StemCell Therapy

The first-in-human, universal chimeric receptor antigen (CAR) T-cell (CAR-T) therapy GC027 was tolerable and resulted in antileukemic responses among patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL), according to results from a phase 1 trial presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I 2020.1

Theuniversal CAR T cells target CD7, which, according to Xinxin Wang, PhD, ofGracell Biotechnologies Co, Ltd, in China, and lead author and presenter of thestudy, is a good target for T-ALL because it is expressed by more than 95% ofT-ALL patients.

GC027 isallogeneic, which may prevent the development of graft-versus-host disease. Theproduct is introduced using lentivirus for rapid elimination of T-ALL cells. Preclinicalstudies showed efficacy in a T-ALL xenograft model, and this prospective studyevaluated the safety and efficacy in humans.

Thesingle-arm, open-label study treated 5 adult patients with relapsed/refractoryCD7-positive T-ALL with a single infusion of 1 of 3 different dose levels ofG027: 0.6 x 107/kg, 3 x 107/kg, and 1.5 x 107/kg.Lymphodepletion therapy was administered prior to the G027 infusion. Theprimary endpoint was safety and the secondary endpoints included objectiveresponse rate (ORR) within 3 months after G027 infusion.

Patientswith extramedullary or central nervous system disease were excluded. Atbaseline, the median age was 24 (range, 19-38). Patients were heavilypretreated, with 5 median number of prior therapies (range, 1-9). Two patientshad high-risk disease and the median bone marrow tumor burden was a median of38.2% of blasts. None of the patients had undergone a prior allogeneic hematopoieticstem cell transplant.

Allpatients developed cytokine release syndrome (CRS), 4 of which were grade 3 and1 was grade 4. All cases were manageable and resolved with treatment andsupportive care. None of the patients developed neurotoxicity.

The completeremission (CR)/CR with incomplete hematologic recovery was 100%. By day 28, 4patients achieved a CR with negative for minimal residual disease (MRD) and 3of these patients remained MRD negative up to day 161. One patient achieved CRbut was MRD positive, and relapsed by day 29.

Peak CART-cell expansion in peripheral blood occurred between week 1 and 2.

As the first-in-human, universal CAR T-cell therapy for adult relapsed/refractory T-ALL, Dr Wang said, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. She added that trial enrollment is ongoing.

Reference

Wang X, Li S, Gao L, et al. Clinical safety and efficacy study of TruUCAR GC027: The first-in-human, universal CAR-T therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I; April 27-28, 2020. Abstract CT052.

This article originally appeared on Cancer Therapy Advisor

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First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL - Oncology Nurse Advisor

Alessandra de Oliveira Pinheiro,1 Valria M Lara,1 Aline F Souza,1 Juliana B Casals,2 Fabiana F Bressan,1 Paulo Fantinato Neto,1 Vanessa C Oliveira,1 Daniele S Martins,1 Carlos E Ambrosio1

1Department of Veterinary Medicine, Faculty of Animal Science and Food Engineering, University of So Paulo, Pirassununga, So Paulo, Brazil; 2Private Veterinary Practice, Pirassununga, So Paulo, Brazil

Correspondence: Carlos E AmbrosioDepartment of Veterinary Medicine, Faculty of Animal Science and Food Engineering, University of So Paulo, FZEA- Av. Duque de Caxias Norte, 225, ZMV, Pirassununga 13635-900, So Paulo, BrazilTel +55 19 3565-4113 Email ceambrosio@usp.br

Purpose: Amniotic membrane stem cells have a high capacity of proliferation, cell expansion, and plasticity, as well as immunomodulatory properties that contribute to maternal-fetal tolerance. Owing to the lack of research on human amniotic membrane at different gestational stages, the canine model is considered ideal because of its genetic and physiological similarities. We aimed to characterize the canine amniotic membrane (CAM) cell lineage in different gestational stages and evaluate the expression of immunomodulatory genes.Materials and Methods: Twenty CAMs from early (20 30 days) (n=7), mid- (31 45 days) (n=7), and late gestation (46 63 days) (n=6) stages were studied. The cell features were assessed by cell viability tests, growth curve, colony-forming units, in vitro differentiation, cell labeling for different immunophenotypes, and pluripotent potential markers. The cells were subjected to RT-PCR and qPCR analysis to determine the expression of IDO, HGF, EGF, PGE2, and IL-10 genes.Results: CAM cells exhibited a fibroblastoid morphology and adherence to plastic with an average cell viability of 78.5%. The growth curve indicated a growth peak in the second passage and we obtained an average of 138.2 colonies. Osteogenic, chondrogenic, and adipogenic lineages were confirmed by in vitro differentiation assays. Cellular immunophenotyping experiments confirmed the presence of positive mesenchymal markers (CD90 and CD105) and the low or negative expression of hematopoietic markers (CD45 and CD34). Qualitative analysis of the immunomodulatory functions indicated the expression of the IDO, HGF, EGF5, and PGE2 genes. When stimulated by interferon-gamma, CAM cells exhibited higher IDO levels throughout gestation.Conclusion: The CAMs from different gestational stages presented features consistent with mesenchymal stem cell lineage; better results were observed during the late gestation stage. Therefore, the gestational stage is a key factor that may influence the functionality of therapies when using fetal membrane tissues from different periods of pregnancy.

Keywords: canine stem cells, immunomodulation, fetal annexes

This work is published by Dove Medical Press Limited, and licensed under a Creative Commons Attribution License.The full terms of the License are available at http://creativecommons.org/licenses/by/4.0/.The license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Characterization and Immunomodulation of Canine Amniotic Membrane Stem | SCCAA - Dove Medical Press

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its oncology program will be presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program from May 29-31. More than 80 abstracts in nearly 20 types of solid tumors and blood cancers have been accepted across Mercks broad cancer portfolio and investigational pipeline, including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (in collaboration with Eisai); LYNPARZA (in collaboration with AstraZeneca); and MK-6482 (formerly PT2977), an investigational, oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor.

Despite the challenges we all face due to the COVID-19 pandemic, Merck remains fully committed to supporting the cancer community and to advancing important scientific research from our clinical program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The data to be presented at this years ASCO demonstrate how our deep and diverse oncology portfolio continues to show meaningful outcomes for patients in new tumor types and stages of disease, while long-term survival data for KEYTRUDA in non-small cell lung cancer, renal cell carcinoma and melanoma further support its important role in these types of cancer.

Key abstracts including late-breakers, oral sessions, and select poster discussions and posters to be presented at ASCO include:

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ASCO20 Virtual Scientific Program on Tuesday, June 2 at 2 p.m. ET. Details will be provided at a date closer to the event at http://investors.merck.com/home/default.aspx.

Details on Abstracts Listed Above, Additional Presentations and Key Abstracts with Mercks Collaboration Partners

KEYTRUDA

Breast Cancer

Bladder Cancer

Classical Hodgkin Lymphoma

Colorectal Cancer

Lung Cancer

Renal Cell Carcinoma

Prostate Cancer

Melanoma

Ovarian Cancer

Head and Neck Cancer

KEYTRUDA plus LENVIMA (in collaboration with Eisai)

Hepatocellular Carcinoma

Renal Cell Carcinoma

Endometrial Cancer

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

MK-6482

Renal Cell Carcinoma

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

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Merck to Present New Data from its Broad Oncology Portfolio and Pipeline at the ASCO20 Virtual Scientific Program - Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (Nasdaq: AVRO) and Magenta Therapeutics (Nasdaq: MGTA) today announced a research and clinical collaboration agreement to evaluate the potential utility of MGTA-117, Magentas novel targeted antibody-drug conjugate (ADC) for conditioning patients before they receive one of AVROBIOs investigational lentiviral gene therapies.

The collaboration will combine AVROBIOs leadership in lentiviral gene therapies with Magentas expertise in ADC-based conditioning and is expected to further the two companies shared mission to enable patients to live free from disease. Under the collaboration, AVROBIO and Magenta will jointly evaluate MGTA-117 in conjunction with one or more of AVROBIOs investigational gene therapies. Magenta will retain all commercial rights to MGTA-117. AVROBIO will retain all commercial rights to its gene therapies and will be responsible for the clinical trial costs related to the evaluation of MGTA-117 with AVROBIOs gene therapies.

This agreement with Magenta springs from our strategic focus on maintaining technology leadership in gene therapy, said Geoff MacKay, AVROBIOs president and CEO. AVROBIO has always led by investing early in technological innovations that further the field of lentiviral gene therapy, such as plato, our proprietary platform designed to optimize the safety, potency and durability of our investigational lentiviral gene therapies. Were continually assessing new technologies that could be complementary to our plato platform to sustain our cutting-edge advantage and continue to evolve platos capabilities.

We believe targeted ADCs represent the next generation of medicines to prepare patients for gene therapy or transplant in a targeted, precise way. AVROBIOs investigational gene therapies complement our platform as well as our focus and commitment to patients. This partnership will allow Magenta to validate our conditioning platform in lentiviral gene therapy applications, said Jason Gardner, D.Phil., president and chief executive officer, Magenta Therapeutics. Weve selected ADCs as the preferred modality for our conditioning programs, as we believe they offer the most promising option for more patients. We have optimized our ADCs for gene therapy and transplant settings and look forward to collaborating with AVROBIO to evaluate MGTA-117 in specific gene therapy settings. Magenta will continue to develop MGTA-117 in other diseases, including blood cancers and genetic diseases.

MGTA-117, Magentas most advanced conditioning program, is a CD117-targeted antibody engineered for the transplant setting and conjugated to amanitin, a toxin in-licensed from Heidelberg Pharma. It is designed to precisely deplete only hematopoietic stem and progenitor cells and has shown high selectivity, potent efficacy, wide safety margins and broad tolerability in non-human primate models, suggesting that it may be capable of clearing space in bone marrow to support long-term engraftment and rapid recovery in humans. Magenta plans to complete IND-enabling studies this year.

AVROBIO currently uses a personalized conditioning regimen with precision dosing of busulfan, an extensively validated conditioning agent generally considered to be the gold standard for ex vivo lentiviral gene therapy, based on decades of general use and administration to hundreds of patients treated with lentiviral gene therapy candidates. The treating clinician uses therapeutic drug monitoring (TDM) to evaluate how quickly the patient metabolizes busulfan and adjusts the dose regimen accordingly with the goal of achieving the optimum result. AVROBIO has reported early clinical data with this precision conditioning regimen with TDM in its own clinical trials, adding to a body of data that suggest busulfan can effectively clear space in the patients bone marrow, where stem cells engraft, produce generations of daughter cells carrying the therapeutic gene and make the functional protein the patient needs to maintain cellular health.

About AVROBIO

Our mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease. AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients. Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com. Follow Magenta on Twitter: @magentatx.

AVROBIO Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as aims, anticipates, believes, could, designed to, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs, the expected safety profile of our investigational gene therapies, and the potential and expected benefits of MGTA-117, Magentas investigational antibody-drug conjugate, including the ability of MGTA-117 to deplete hematopoietic stem and progenitor cells in order to clear space in bone marrow to support long-term engraftment in humans, as well as MGTA-117s potential application to AVROBIOs investigational gene therapies. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that AVROBIO may not realize the intended benefit of MGTA-117 with respect to AVROBIOs investigational gene therapies, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Magenta Therapeutics Forward Looking Statements

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including, without limitation, statements regarding the research and clinical collaboration agreement between Magenta and AVROBIO, including the timing, progress and success of the collaboration contemplated under the agreement, the successful evaluation MGTA-117 in conjunction with one or more of AVROBIOs investigational gene therapies under the agreement, the anticipated cost allocation and other commercial terms under the agreement, Magentas strategy and business plan, as well as the future development, manufacture and commercialization between AVROBIO and Magenta. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavor, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation, risks set forth under the caption Risk Factors in Magentas most recent Annual Report on Form 10-K, as updated by Magentas most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission, as well as risks, uncertainties and assumptions regarding the impact of the COVID-19 pandemic to Magentas business, operations, strategy, goals and anticipated timelines, including, without limitation, Magentas ongoing and planned preclinical activities, ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, timelines for regulatory submissions and financial position. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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AVROBIO and Magenta Therapeutics Announce Collaboration to Evaluate Targeted Antibody-Drug Conjugate as a Potential Conditioning Regimen for...

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, "Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results" (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemanns presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineages website.

"This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient," stated Brian M. Culley, Lineage CEO. "As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market."

"As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response," stated Christopher D. Riemann, M.D. "The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire followup period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI."

KOL Call Information and Webcast

Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineages website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.

Story continues

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineages objectives with respect to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Contacts

Lineage Cell Therapeutics, Inc. IR Ioana C. Hone(ir@lineagecell.com)(442) 287-8963

Solebury Trout IR Gitanjali Jain Ogawa(Gogawa@troutgroup.com)(646) 378-2949

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Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy - Yahoo Finance

VANCOUVER, Washington, May 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the Company is expecting enrollment completion for its 75 patient, Phase 2 double blinded, placebo controlled, randomized study by the end of this month.

CytoDyn has submitted a request to the FDA to grant expanded access, also known as compassionate use, to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections. Many severe and critically-ill patients, who have received off-label immunomodulatory treatments for COVID-19, are excluded from participation in the Companys Phase 2b/3 clinical trial and could potentially benefit from access to leronlimab under a compassionate use program.

There are 49 COVID-19 patients who have enrolled for treatment with leronlimab through eIND. Four out of 11 critically ill patients with a multitude of pre-existing conditions survived after treatment, and of the next 38 patients, many were extubated, improved, or were discharged.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We are very excited about the continuing positive responses from eIND patients following their treatment with leronlimab. We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program. During this past Saturday, we had to overcome many obstacles for two patients who desperately wanted leronlimab. One patient was in the same hospital that enrolled the first 11 patients and the second was a VIP patient in Los Angeles. Under the compassionate use program, we could avoid and quickly overcome this type of stress and turmoil which was very difficult for the patients, their families, the physicians, and CytoDyn. The daughter of a patient who was on a machine used for severe heart and lung failure contacted us directly and expressed her immense gratitude believing leronlimab saved her mothers life. These are amazing times for us at CytoDyn; with the opportunity to wake up every day with the potential of saving somebodys life. For sure, I could never have imagined such an incredible honor.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation and a rolling review previously assigned by the FDA and plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible...

Cryopreservation has become an indispensable step in the daily routine of scientific research as well as in a number of medical applications, ranging from assisted reproduction and transplantations to cell-based therapies and biomarker identification. It is hardly possible to picture todays scientific and medical advancements without this technique.The successful development and implementation of all the therapeutic and scientific discoveries involving cryopreservation relies on the correct and safe translation of the method from the laboratory to the clinical and manufacturing scale.

With the need to correctly use this technique, more research is focusing on optimizing cryopreservation methods and investigating what the long-term effects and consequences are on the physiology of the cryopreserved material.

An important part of cell therapy research is focused on adult stem cells (ASCs). ASCs can be derived from different sources such as peripheral blood, bone marrow or adipose tissue and display strong promises because of their capacity to differentiate into any cell type of the human body.In recent work3, the team of Michael Pepper at the Institute for Cellular and Molecular Medicine in Pretoria, South Africa, explored the effects of cryopreservation on the differentiation ability of adipose tissue-derived stem cells (ADSCs). After analyzing gene expression of key adipogenic genes and the degree of differentiating cells, characterized with high levels of CD36 and intracellular lipid droplets, the scientists reported that slow freeze cryopreservation of cells shortly after their isolation causes no alterations on their ability to differentiate. Pepper is convinced of the necessity to perform such analysis when cryopreserving important cell pools: It is critical to do a post-thaw analysis of cell function to determine how the cryopreservation may have affected the cells.His team is analyzing the effects of cryopreservation on other cell types largely used in cell-based therapies such as hematological stem cells and peripheral blood mononuclear cells (PBMCs). Although they didnt observe major alterations in terms of immunophenotyping or the post-thaw proliferation of the cells, Pepper expresses his concern that more subtle characteristics might be affected.

Correct cryopreservation of cells intended for therapeutic use is crucial. This is very important particularly as cells may persist for a long time in the recipient. This area of cell therapy research definitely requires more attention, Pepper says. Moreover, his words reflect on the need to evaluate not only the direct post-thaw recovery, but to look deeper into the late-onset effects cryopreservation might have and ensure that transplanted cells have preserved their therapeutic properties.

In contrast to slow freezing, vitrification relies on the fast freezing of the material by putting it in high concentration of cryoprotectant and in contact with liquid nitrogen. This method allows the direct transition of water from liquid to solid state without crystal formation. The highly concentrated cryoprotectant prevents ice formation and therefore there is no need for slow cooling.

Although vitrification has a great potential, there are a couple of parameters that are a point of concern. The quick and drastic freeze is possible thanks to the high concentration of cryoprotectant, but the latter is also associated with higher toxicity. In some cases, an additional limitation is the direct contact of the sample with liquid nitrogen which is a predisposition for viral or bacterial contamination.The team of Christiani Amorim at the Institute for Experimental and Clinical Research in Louvain, Belgium, is approaching the challenges of vitrification in the context of ovarian auto-transplantation. Ovarian auto-transplantation consists of preserving a piece of ovarian tissue with active follicles from the pre-therapeutic ovary of a cancer patient, as chemotherapy often has damaging effects on the reproductive organs. This tissue sample will be conserved and auto-transplanted onto the patients ovary when she has recovered and wishes to become pregnant.In their recent research4, the authors used stepped vitrification, in which the concentration of the cryoprotectant is gradually increased while simultaneously temperature decreases. This avoids ice crystal formation and also prevents cryoprotectant toxicity.Although stepped vitrification has previously given good results in bovine ovarian tissue5, this was not the case for human ovarian tissue. The scientists didnt detect normal follicles following thawing and linked this to high cryoprotectant toxicity. Indeed, they observed all signs of dimethyl sulfoxide (DMSO)-related cell membrane damage: significant organelle damage, cell membrane disintegration and apoptosis. These observations imply on the variability of outcomes that the method could give when applied to the same type of tissue but from a different organism.Amorim is positive about the future of their method and recognizes the need for further research on the topic: I can see a great potential in the stepped vitrification approach, but I also believe that there is a lot we still need to learn before thinking about using it as method of choice for human ovarian tissue cryopreservation. The high cryoprotectant concentration that should be applied in this approach is my first concern. () Our study clearly showed that 50% DMSO is too high, so we need to try lower concentrations or combine it with other cryoprotectants.

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Freezing Life: The Current Trends in Cryopreservation - Technology Networks

MIAMI (CBSMiami) The FDA gave Baptist Health approval to test a stem cell treatment on COVID-19 patients and so far its come back with positive results.

The treatment has proven successful with three patients.

One of those patients, Ruth Ramirez says it saved her life.

Ramirez was discharged from the hospital on Friday afternoon.

They saved my life. They definitely saved my life, said Ramirez.

Ramirez recently received stem cells from an umbilical cord known as mesenchymal cells.

Mesenchymal stem cells have the ability to reduce cytokine levels, said doctor Guenther Koehne.

Baptist Hospital says patients like Ramirez showed a reduction of their oxygen requirement from 100% to less than 50% within days of the infusion, accompanied by a significant reduction in levels of various key circulating inflammatory markers.

I couldnt breathe. I had a fever a headache I was nauseous, said Ramirez.

Ruth, an employee of the Miami Cancer Institute, tested positive for COVID-19 back on April 7th. She was admitted to the ICU and ended up on a ventilator fighting for her life.

Knowing she may lose consciousness she gave her sister power of attorney. That is when doctors Koehne and Javier Perez Fernandez approached the family about this FDA approved experimental therapy.

Im a person who jumps. I jump with hope with the best outcome there is on the other side. I think she took that into consideration with my characteristic and said Ruth would probably do this.

According to friends, Ruth was in ICU for three weeks, on a ventilator, and unable to breathe on her own.

All that time, she was away from her two small kids. That was several days ago.

On Friday, she was discharged.

To be here in this room, alone, and not being able to hold them. It was hard you know its hard.

As soon as they told me that I was going home I was like what?? And that I tested negative again I was like wait!! That changed my mood completely

Still fuzzy on the timeline, Ruth says shes unsure where along the way she received the treatment but is thankful for the doctors and wants others to know there is hope.

You know I hear the bells here all the time the eye of the tiger thats the song that you walk out of when you come out with coronavirus. Its such a pleasure hearing it all the time now. More than I heard it yesterday.

Not only did the doctors step up, but so did her co-workers who set up this Ruthie-strong go fund me page to help with bills and expenses.

They also helped take care of her family.

They would send food to them. Groceries. My kids were taken care of my sister was taken care of. She didnt have to leave from the house.

Theyre just amazing.

The University of Miami is also working on a clinical trial using mesenchymal cells which we reported on in April.

Click here if you would like to donate to her GoFundMe page.

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Coronavirus Update: Baptist Hospital Patient Credits Stem Cell Treatment With Saving Her Life - CBS Miami

HONG KONG, April 27, 2020 /PRNewswire/ -- Global Cord Blood Corporation (NYSE: CO) ("GCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, today provided an update on the impact of the 2019 novel coronavirus ("COVID-19") on the Company's expected fiscal 2021 operations.

Based on information available to date, management estimates that the Company's new subscriber number in fiscal 2021 will decrease to 60,000-65,000, a 19%-29% decrease from the Company's fiscal 2020 new subscriber target, which is 80,000-85,000.

Under the anti-pandemic policies and measures taken by the Chinese government, the risk levels associated with major cities has decreased, and social and economic activities are gradually resuming. However, hospitals, which are the Company's key promotion and marketing channel, remain at the forefront in fighting this pandemic and remain under strict supervision and control. In the Company's key markets of Beijing municipality, Guangdong province, and Zhejiang province, the Company's usual marketing and promotion activities are significantly impacted by the control measures implemented by authorities and hospitals, prompting it to constantly readjust its marketing and promotion activities.

During this difficult time, the Company has prioritized employee safety and protection by providing personal protective equipment ("PPE") to everyone, especially the frontline sales team, and by implementing additional disinfection measures and work streams in its day-to-day operating procedures. The management team has also recalibrated its marketing and promotion efforts in order to better serve and engage with target and existing clients. As a result, operating costs have increased.

The negative economic impact brought forth by the COVID-19 pandemic has affected numerous industries and further erodes already weak consumer sentiment. GCBC management expects that these conditions, compounded by other factors, will adversely affect and potentially delay potential clients' pregnancy plans. Therefore, management believes it is possible that the number of newborns in the Company's respective regions will remain low in the near term. While the world is facing various challenges in response to COVID-19, China may continue to tighten its anti-pandemic policies and measures, which would add further headwinds to the recovery pace of China's economy and consumer confidence. GCBC management does not expect these conditions to be significantly improved in the near term.

Under the impact of the COVID-19 pandemic, the Company management is not optimistic regarding the general operating environment. Current operating data points to the low end of the expected fiscal 2021 new subscriber range. The management would like to remind investors that the above estimation is a forecast that reflects the Company's current and preliminary views, which is subject to change and substantial uncertainties, particularly in view of the potential impact of the COVID-19 outbreak, the effects of which are difficult to analyze and predict. The management will continue to monitor the evolvement of the pandemic and does not exclude the possibility of further adjusting the Group strategy and target as future situation and events unfold. Meanwhile, the management will continue to proactively explore and identify opportunities within the healthcare industry value chain to ensure the Group future growth over the long run.

About Global Cord Blood Corporation

Global Cord Blood Corporation is the first and largest umbilical cord blood banking operator in China in terms of geographical coverage and the only cord blood banking operator with multiple licenses. Global Cord Blood Corporation provides cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services. For more information, please visit the Company's website at: http://www.globalcordbloodcorp.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These statements relate to future events or the Company's future financial performance. The Company has attempted to identify forward-looking statements by terminology including "anticipates", "believes", "expects", "can", "continue", "could", "estimates", "intends", "may", "plans", "potential", "predict", "should" or "will" or the negative of these terms or other comparable terminology. These statements are only predictions, uncertainties and other factors may cause the Company's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The information in this press release is not intended to project future performance of the Company. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company does not guarantee future results, levels of activity, performance or achievements. The Company expectations are as of the date this press release is issued, and the Company does not intend to update any of the forward-looking statements after the date this press release is issued to conform these statements to actual results, unless required by law.

For more information, please contact:

Global Cord Blood CorporationInvestor Relations DepartmentTel: (+852) 3605-8180Email: ir@globalcordbloodcorp.com

ICR, Inc.William ZimaTel: (+86) 10-6583-7511U.S. Tel: (646) 405-5185Email: William.zima@icrinc.com

View original content:http://www.prnewswire.com/news-releases/global-cord-blood-corporation-provides-further-update-on-covid-19-301047374.html

SOURCE Global Cord Blood Corporation

Company Codes: NYSE:CO

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Global Cord Blood Corporation Provides Further Update on COVID-19 - BioSpace

Stem Cell Restore is a formula that works toward improving your health on a cellular level to decrease age-related weakness and fatigue. This product employs natural ingredients for reaching its goals such as resveratrol, black current cocktail, icariin, and grape seed.

Multiple research works from renowned universities back the approach that this product takes. The best part is that it makes you feel stronger, younger, more refreshed, and more energetic without requiring you to get injected with needles. A simple and convenient solution. Another anti-aging plus weight loss supplement that you can opt for is Resurge. This is a new formula by John Barban. Interested folks can learn more about Resurge customer reviews on USAToday.

Stem Cell Restore Review

Aging is the only thing in your life that is bound to happen. Unfortunately, it is not the best experience. Sure, it gives you wisdom, but those wrinkles, that weakness, declining energy levels all these negative factors completely loot the good things. After all, no one likes to wake up in the morning to feel down and weak. No one likes it when it their joints ache or when they look in the mirror to see a dull reflection.

This brings us to possible solutions that you can go for. One of these is Stem Cell Restore. This is a potent dietary supplement that has been made using natural ingredients. The product is backed by science which is what marks it as reliable. Since it comes in the form of capsules, it can be a convenient addition to your routine. Hence, if you are on the lookout for an age-reversing formula, this is one that you can invest in.

Why Choose This Product?

Around the globe, women and men alike are waiting for a magical solution for saving themselves from accelerated aging. There certainly are many options available out there. However, most of these are not worth it. Why? Because they come with negative side effects. Not to mention, these so-called techniques for erasing the effects of aging are all supremely painful. They involve countless injections or an elaborate surgery.

Would you like to still go for these youth preserving tactics? Surely, youre at the very least hesitant. If you decide to go ahead nevertheless, know that the procedures are expensive. They cost hundreds of dollars and still, they are unnatural and eventually make your skin sag. This is where Stem Cell Restore comes into the picture and steals the limelight. The dietary supplement is based on the concept of stem cell surgery.

However, it has three favorable points that win over any surgery. First of all, it doesnt cost as much. In fact, you get to become youthful, energetic, and strong all with a solution that is less than $100. Secondly, the product happens to be completely natural. It doesnt contain any harmful components such as chemicals, additives, preservatives, and the like. This translates to safe usage. Lastly, theres no needles involved; you are just supposed to take the pills regularly.

Working Of This Product

Stem Cell Restore taps into the idea of repairing cells and rejuvenating them. By doing so, it is able to refresh your health completely. All your parts from tendons and joints to your heart and kidneys are able to function better as a result. Old cells are repaired at a fast rate and new ones are created. This makes you feel fresher, and more active. Its not uncommon of people to experience bodily aches and fatigue after crossing 30 years of age.

This product is a suitable solution for everyone. It gets to the core of preserving youth and improves health. Moreover, it also tackles the issue of inflammation which is what disturbs health in numerous ways. Unlike mainstream products, your skin is not the only organ that benefits. In fact, your entire body experiences the effects. To reach its goals, the formula employs only natural ingredients which are effective at their job. As mentioned above, Resurge is another formula for deep sleep and anti-aging. It comes with a money-back guarantee. You can check out more Resurge reviews on Yahoo Finance before deciding which one to buy among the two.

Ingredients Of This Product

Stem Cell Restore has an entirely natural composition. It doesnt comprise of any such ingredients which can have damaging effects in the short- or long-run. The product is a winner mainly because of this. No additives, fillers or other such harmful components are present in the formula. Since all the ingredients are completely organic you dont have to worry about any negative side effects of use. Lets take a look at the ingredients:

Pricing Of The Product

Did you know that you can get this product for absolutely free? Yes, thats true. For a trial period, the dietary supplement is entirely free of cost. You just have to pay for shipping and handling which just requires $9.95 from your wallet. The trail period lasts for 30 days.

If the product satisfies you, its yours and automatically charges are deducted from your account or card. Thats simple and gives you a chance to see whether or not this supplement actually works. There are also three bonus products that tag along with this supplement. These come for free as well. Heres a list of the bonus product that accompany:

Verdict

Stem Cell Restore is a great product for maintaining youthful energy and strength. The product is great for recovering from the pain and fatigue that usually occurs after the age of 30. This formula repairs and encourages the production of cells through the body. In this way, it improves each organs functionality and hence, overall health. You can know more about this dietary supplement by visiting its website online.

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Stem Cell Restore Helps Regain Youthful Strength And Energy - ZOBUZ - Zobuz

The market expects Fate Therapeutics (FATE) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2020. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus Estimate

This clinical-stage biotech company that develops stem cell treatments is expected to post quarterly loss of $0.38 per share in its upcoming report, which represents a year-over-year change of -26.7%.

Revenues are expected to be $2.07 million, down 21.3% from the year-ago quarter.

Estimate Revisions Trend

The consensus EPS estimate for the quarter has been revised 49.28% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings Whisper

Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Fate Therapeutics?

For Fate Therapeutics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +13.16%.

Story continues

On the other hand, the stock currently carries a Zacks Rank of #2.

So, this combination indicates that Fate Therapeutics will most likely beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?

Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Fate Therapeutics would post a loss of $0.39 per share when it actually produced a loss of $0.37, delivering a surprise of +5.13%.

Over the last four quarters, the company has beaten consensus EPS estimates just once.

Bottom Line

An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Fate Therapeutics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportFate Therapeutics, Inc. (FATE) : Free Stock Analysis ReportTo read this article on Zacks.com click here.

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Fate Therapeutics (FATE) Expected to Beat Earnings Estimates: Should You Buy? - Yahoo Finance

Study on the Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market

The report on the global Platelet Rich Plasma and Stem Cell Alopecia Treatment market reveals that the Platelet Rich Plasma and Stem Cell Alopecia Treatment market is anticipated to grow at a CAGR of ~XX% during the forecast period (2019-2029). The report provides a thorough assessment of the impact of the COVID-19 pandemic on the current and future prospects of the Platelet Rich Plasma and Stem Cell Alopecia Treatment market across various geographies. Further, the report provides accurate data related to the business continuity and contingency strategies adopted by leading market players operating in the Platelet Rich Plasma and Stem Cell Alopecia Treatment market.

The quantitative and qualitative assessment of the various segments of the Platelet Rich Plasma and Stem Cell Alopecia Treatment market enables stakeholders, investors, upcoming and established market players to devise robust business development strategies. The report tracks the recent developments within the Platelet Rich Plasma and Stem Cell Alopecia Treatment market in terms of innovation, technological progress, regulatory framework, supply chain bottlenecks, and more.

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Major Doubts Pertaining to the Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Addressed in the Report

Segmentation Analysis of the Platelet Rich Plasma and Stem Cell Alopecia Treatment Market

The growth potential of the Platelet Rich Plasma and Stem Cell Alopecia Treatment market in each region is accurately depicted in the report. The market attractiveness index included in the report enables readers to identify the most lucrative pockets within the Platelet Rich Plasma and Stem Cell Alopecia Treatment market and make informed business decisions.

The report throws light on the adoption pattern of different products along with a thorough analysis of the pricing and supply-demand ratio of each product.

Competitive Landscape

The competitive landscape section of the report tracks the business proceedings of the key players operating in the Platelet Rich Plasma and Stem Cell Alopecia Treatment market. The pricing, marketing, sales, and promotional strategies adopted by each market player is represented in the report. The contingency strategies of different players amidst the COVID-19 pandemic are touched upon in the presented report.

Market: Drivers and RestrainsThe research report has incorporated the analysis of different factors that augment the markets growth. It constitutes trends, restraints, and drivers that transform the market in either a positive or negative manner. This section also provides the scope of different segments and applications that can potentially influence the market in the future. The detailed information is based on current trends and historic milestones. This section also provides an analysis of the volume of sales about the global market and also about each type from 2015 to 2026. This section mentions the volume of sales by region from 2015 to 2026. Pricing analysis is included in the report according to each type from the year 2015 to 2026, manufacturer from 2015 to 2020, region from 2015 to 2020, and global price from 2015 to 2026.A thorough evaluation of the restrains included in the report portrays the contrast to drivers and gives room for strategic planning. Factors that overshadow the market growth are pivotal as they can be understood to devise different bends for getting hold of the lucrative opportunities that are present in the ever-growing market. Additionally, insights into market experts opinions have been taken to understand the market better.Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market: Segment Analysis The research report includes specific segments such as application and product type. Each type provides information about the sales during the forecast period of 2015 to 2026. The application segment also provides revenue by volume and sales during the forecast period of 2015 to 2026. Understanding the segments helps in identifying the importance of different factors that aid the market growth.Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market: Regional AnalysisThe research report includes a detailed study of regions of North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market: Competitive LandscapeThis section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.Following are the segments covered by the report are:Androgenic AlopeciaCongenital AlopeciaCicatricial Or Scarring AlopeciaBy Application:HospitalDermatology ClinicOtherKey Players:The Key manufacturers that are operating in the global Platelet Rich Plasma and Stem Cell Alopecia Treatment market are:KerastemEclipseRegen Lab SAStemcell TechnologiesRepliCel Life SciencesHistogenGlofinn Oy.Competitive LandscapeThe analysts have provided a comprehensive analysis of the competitive landscape of the global Platelet Rich Plasma and Stem Cell Alopecia Treatment market with the company market structure and market share analysis of the top players. The innovative trends and developments, mergers and acquisitions, product portfolio, and new product innovation to provide a dashboard view of the market, ultimately providing the readers accurate measure of the current market developments, business strategies, and key financials.

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Key Findings of the Report

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Coronavirus (COVID-19) Business Impact Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Size of Dynamics, Products, Application Forecast...

In the new HBO show Betty, the term "Betty" is used as a somewhat derogatory term by male skateboarders who see women skaters as posing hangers-on. The plot centers around a group of female friends living in New York City, chronicling their day-to-day lives, freely skating through the streets of Manhattan, hitting weed pens, and navigating the winding road of adulthood. Skateboarding is their escape, a means for enjoyment, and a form of expressiondisparaging comments about whatever veiled intentions they seem to have, be damned.

For the actress Ajani Russell, who plays Indigoa young woman trying to mask her silver-spoon upbringing from her homegirlsskincare and makeup are linked to her artistic interests. The Brooklyn-born 22-year-old lives in Los Angeles, where she's been attending classes at Cal Arts and is currently holed up at home during quarantine with her roommate, creating characters using wacky makeup and taking baths to pass the time. Like skating, modeling, and multimedia art projects, beauty is a way for Russel to flesh out her own ideas and gain inspiration. She sees makeup as something that is no longer relegated to one gender or another, a "Betty" or not. It's just a way to have fun, get creative, and for now, stave off some boredom.

Here, Russell shares her favorite K-beauty products, why skincare is the most important part of the beauty process, and why, despite a traumatic experience on a photoshoot set, she still feels invigorated by the fashion industry.

Its interesting to me that your character in Betty gets scouted to be a model, and you also were cast to model in the Rag and Bone show this past fashion week. Its like art imitating life.

The script is based loosely on things that happened to us in real life. Theyre all topics were passionate about, discussing from our perspectivesthings that havent been seen before, necessarily, on this type of platform. That was one of the things that was the important for us to share with people.

There's a scene in the show in which you're modeling in a photo shoot, and the photographer instructs you to Give me food stamps, give me WIC! That really happened to you?

It was something I experienced a few years ago. They didnt say those words exactly, but the context of the shoot, was a girl gang shoot, cool girls in groups, different types of girl gangs. I showed up to set, and it was mostly trying to be a Chola, Uptown, Latina vibe, but they were cornrowing Russian modelss hair, it was at 7 in the morning, and there was no breakfast. They put a fake scar on one girl, and a fake tattoo on another girl. I heard the makeup artist be like, Make it more ghetto. I was talking to the other models, and they were so uncomfortable. Im Puerto Rican and I was very offended. It was traumatic for me. I left that shoot, I didnt actually follow through with it because once I was in hair and makeup, I looked in the mirror and I was furious.

Despite this negative experience, I noticed on your Instagram and also in the show that beauty and fashion do seem like ways of expressing yourself.

I love beauty, and fashion and I love how both can be tied into art. I'm studying art, so I find myself being inspired by modelingit informs my art, which then informs my skateboarding, and whatever Im working on at the moment.

What are your favorite go-to beauty products?

I am big on skincare, and I love a nice glowa dewy, moisturized look. I have dry skin, so I love Korean beauty. I like Innisfree products. I have this J.One Jelly Pack Primer, which acts as a top layer for all my moisture products. Another one is the Shiseido Aqua Label Special Gel Cream. I bought it at the airport in Japan because I was flying to Milan and I needed a moisturizer. I had been flying all week and my skin was so thirsty. I asked the woman in the cosmetics shop, What is your favorite, most moisturizing product? And she pointed this one out.

Did you learn any beauty tips from your Betty costars?

How to place little gem accessories in patterns on my face, and using different colors for makeup that I would have never thought to try. I remember one episode, Dede [Lovelace] had on neon green mascaraI've used other colors like purple and red on my eyelashes, but not those hot pinks and vibrant colors. That was so cool.

What was one good beauty trick you picked up from the makeup artist Natalie Young on set?

Natalie would do skincare routines with us. After the day was done, she would wash our face with a cold makeup remover cloth, which she would dip in ice, then wipe off all our makeup with it, and then she would put a hot towel on our faces. Then she'd apply serum, and a final light moisturizer. I remember when I was shooting the movie, Skate Kitchen, the makeup artist didnt have a process like Natalie did. I remember my skin was breaking out at that time, because I have very sensitive skin and Im not used to wearing makeup all the time. But the makeup artist on Betty was really attentive to my skin needs.

Natalie was really fun and loved to play around with looks. If there was a look I was really inspired by that I found on Instagram, I'd be like, Can we do something like this? Shed be like, Lets do it. She was all for trying out colors and glitter. I actually found this brand of makeup, Kosas, through her. They have liquid glitter pigments, cream blushes, and highlighters that I love.They also have a tinted skin oil, and it makes my skin look like butter.

What products, if any, did you wear on set?

I dont usually wear makeup on the day-to-day. I like mascara and bronzer or highlighter. I use The Balm cosmetics, they have this nice bronzer called the Betty Lou-manizer.

How have you seen your beauty regimen change in quarantine?

In quarantine, Im making characters with makeup, just because I think its fun and Im bored.

I did a campaign for Wet 'n' Wild a while back. They did this Pac Man collaboration last year, and they sent me the stuff, but I had never used it because its all crazy colors. So now, I'm trying it out. They have blue lip gloss that Ive been really into lately.And I've been doing lots of face masks.

Is there any face mask in particular that youre loving right now?

Im using Formula 10.0.6 Deep Down Detox Ultra-Cleansing Mud Mask. Its a mask with orange and bergamot.

So its not a sheet mask.

No, this ones a clay mask. For paper or sheet masks, theres this Korean brand Malie System that has all these different types of masks. I got the variety pack, with aqua, pomegranate, pearl, snail, and stem cell masks, which I love.

Whats your nightly bedtime beauty routine now?

I wash my face. I have two facial cleansers: one is a Shea Moisture African Black Soap, and its a facial scrub. I use that one, or I use La Roche Posay's cleanser. But I dont think I like the La Roche Posay one as muchit dries out my skin.

But everyone swears by that brand.

Yeah, my roommate was the one who recommended it to me. But you gotta find your own routine, and listen to your skin.

When you wake up in the morning, whats the first thing you do?

I wash my face, with just water. Ill pat my face down and then Ill put on Whamisa's Organic Flower Deep Rich Essence Toner. I love this toner so much. During the day, I use APieu Pure Block Aqua Sun Gel. I put it on every day, since Im in California, and I like to go outside and be in the sun. And I also love the Dr. Barbara Sturm eye cream. That stuff, I dont know what it isits like magic. Itll give you baby eyes.

Whats your ideal spa day and where?

I dont do too many spa days, but if I had to choose, probably a Korean bathhouse. My Korean friend took me one time to a bathhouse in Los Angeles. She was like, youre going to sit in this water for 40 minutes, and when I come back, Im going to scrub you. She scrubbed down my whole body, and there were layers of skin melting off of me. It was so crazy. [Laughs.]. She got some kind of satisfaction she got from scrubbing all my skin off. She was like, Now youre baby smooth.

I also went to the Dr. Sturm store in New York once to get the Glow Facial, I believe it's called. I dont remember the womans name, but she had magic hands. She made me look like a baby: like, two years old, fresh out the womb, theres not a pore in sight on my skin.

Youve gotta find out what that womans name is.

I know. We were talking about her kids, we were really bonding. I have her card somewhere, I saved it in my wallet.

What is your favorite form of self care?

My favorite form of self care probably involves a face mask, a cup of tea, and a bathwatching anime in the bath is my favorite thing to do. I did that two days ago, because I was skateboarding, and I fell. My knee was so swollen so I took a bath. I was in there for, like, two hours and I came out all wrinkled, and my roommate was like, youve been in there for a while. I was wondering if you were okay.

Bathing is an underrated, restorative beauty act. I love soaking in natural hot springs.

I did that once in Tokyo, but only once. And I wish I could do it every single day.

Related: Betty Director Crystal Moselle on the Skate Culture Tipping Point

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Betty Star Ajani Russell Watches Anime in the Bathtub as a Form of Self-Care - W Magazine

The daughter of rock legend Ozzy Osbourne and talk-show favourite Sharon, Kelly was always destined for a career in the spotlight.

After topping the charts, Kelly became a staple of the silver screen - but she really found her groove on TV, critiquing celebrity style and showing that unapologetic Osbourne family wit.

Watch the full story above

Now, Kelly is taking the social distancing message to her millions of followers - making headlines with her Stay Home for Ozzy campaign.

There were so many people that werent looking at this in a way which I thought was appropriate, Osbourne said.

It was very selfish, like its not going to affect me.

A lot of people dont have someone to stay home for. So I thought, if you are a fan of my dad and one of those people who dont have parents anymore, then maybe if I do this, people will stay home for my dad.

It did work and it made people look at it differently.

And Im encouraging people to think about everyone else.

Kelly is currently in isolation in Los Angeles and went three weeks without seeing her parents Ozzy and Sharon as they are both high-risk.

Sharon is a cancer survivor, and Ozzy is battling Parkinsons disease.

My dad has been doing a new stem cell treatment, which is actually working, Osbourne.

I think hes frustrated because hes feeling better so he wants to get out and do stuff, and he cant.

My dad has technically been living under quarantine rules for a year and a half. So now that hes feeling better, its so frustrating for him.

He is very, very strict about who were letting in the house, and keeping everything clean.

I am not there - I dont ever want to go into the house.

We do have to work together this week, so the company we are working with is providing us with tests and that way, I can be in the same room as him - but I refuse to be any closer than 12 feet to him.

Its just not worth the risk.

Kelly was also showing symptoms of coronavirus at one point - but has since been tested and confirmed negative.

After the negative test result, she shared an emotional video of her first hug with brother Jack since the pandemic broke.

I can honestly tell you it was the best hug I have ever had in my life, Osbourne said.

It will make me cry, I cant talk about it. Me and him, I hadnt touched another human in over two months. And to get that moment with him was so nice.

We both had a little tear I afterwards.

Like everyone else, I have fears and anxiety about it - but the way I have been looking at it is we will never have a time like this ever again, Osbourne said.

I took the time to think about what else is broken that I needed to fix - whether its things in my house, whether its that box of stuff I promised I would unpack and organise five years ago - and fixing the last little pieces which were broken in me.

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I started working out again, and Im just getting used to being happy with me in my own time.

Granted, I have those moments when I feel sorry for myself - but this was the choice I made.

It has been difficult, but it is for everyone. I just try and think about how I can help rather than sit here and complain.

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Kelly Osbournes heartache over socially distancing from Ozzy and Sharon after coronavirus scare - 7NEWS.com.au

VANCOUVER, Washington, April 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced conditional acceptance by the U.S. Food and Drug Administration (FDA) of the proprietary name Vyrologix (pronounced - vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States. In addition, the Company has also received a notice of allowance from the U.S. Trademark Office for the Vyrologix mark.

Final approval of Vyrologix as the proprietary name for leronlimab is conditional on FDA approval of the Companys Biologics License Application and new drug application.

We are pleased to receive the FDAs conditional acceptance of Vyrologix as the proprietary name for leronlimabs combination therapy treatment of HIV, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. This acceptance builds on the exceptional results from our clinical trials and our collaboration with Vyera Pharmaceuticals to commercialize and market this potential treatment to fulfill the unmet needs of HIV patients. We are also excited about the stylized Vyrologix mark and logo, which we will share immediately upon acceptance of our U.S. trademark application.

The Company also announced the appointment of Michael D. Mulholland as Interim Chief Financial Officer, who most recently served as Executive Advisor to the CEO and Senior Vice President-Finance. Mr. Mulholland joined the Company in December 2012 and served as Chief Financial Officer, Treasurer and Corporate Secretary until November 2019.

Dr. Pourhassan, stated, We are pleased to have Mike return to a senior leadership role. His deep experience and knowledge will help us navigate through the myriad of opportunities before us and assist our team to maximize shareholder value.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498[emailprotected]

Excerpt from:
CytoDyn Announces Vyrologix as Proprietary Name for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients in the United...

Sarojini Harris and team at Jinis Curry will give 30 meals today in their Pay Forward Program

Sarojini Harris, owner and chef behind Jinis Curry is no stranger to feeding hungry folk, but she is taking it to the next level with her Pay Forward Program. Her small family restaurant has been doing take out at the Promenade Food Court since October of 2013. She is open during COVID-19, one of the food options in Wailuku town open from 11am to 2pm for pick up orders. Her menu features curry, dahl, samosas, salad and other lunch plate options. I like to order family style from Jini, so I request curry and dahl in large amounts rather than plate size, and bring home for multiple meals.

Harris says her business has dropped by 80% during this shutdown, but because of her loyal returning customers she remains operational. Harris has been offering free entrees on every plate to first responders and also feeding hungry houseless looking for food. She has had a policy of not turning away hungry and helpless if they cannot pay for years, but realized it is more important than ever during this time.

She set up the Pay Forward lunch pick up program to expand on those concepts. Her first sponsorships came from her customers and sisters Bhagyadeep Singh and Hardeep Singh. They gave their stimulus money to feed Maui residents who lost their jobs and are still waiting for unemployment benefits. You can sponsor a meal as you pick up lunch by adding a little extra to your bill if you are paying by credit card, or dropping some cash into a basket at the register. You can also email Harris at fijiindianfood@gmail.com.

To sign up to get one of her sponsored meals call or text 808-276-7215 to reserve either a chicken curry plate, or vegan curry plate. Her first 30 meals sold out and will be distributed today, May 1st. She is doing another run of meals on Wednesday May 6. Then another is planned for the following Wednesday.

Harris also has $25 and $100 gift vouchers to buy by phone if you want to call in and pay forward meals.

Jinis CurryFiji Indian Food LLCPromenade Foodcourt #4

2050 Main Street, Wailuku, HI 96793Phone: 808-243-3454

Cell: 808-276-7215Website:www.fijiindianfood.com

Facebook:www.facebook.com/FijiIndianFoodLlc

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Jini's Curry Feeds the Hungry with Pay Forward Lunch Program - Maui Time

54 eINDs approved by FDA and 49 patients have been treated with leronlimab thus far

VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administrations (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Story continues

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -...

Company to hold conference call for analysts and investors today at 18:00 CET

Amsterdam, The Netherlands, April 30, 2020 Kiadis Pharma N.V.( Kiadis, Kiadis Pharma or the Company) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces its audited 2019 Annual Results for the year ended December 31, 2019, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.

Arthur Lahr, CEO of Kiadis commented, 2019 was a transformational year for Kiadis with the acquisition of CytoSen Therapeutics in the first half; the termination of the ATIR101 development program in the second half; and the restructuring and refocus of our organization solely on Kiadis natural killer (K-NK) cell therapies in the fourth quarter. We were faced with some difficult decisions during the year, but we were always guided by our core values of always doing what is right and putting our patients first. In the face of adversity, I am proud of the decisions that our team has made and believe that we have emerged in 2020 as a stronger organization.

Key Developments (including post reporting period)

Revenue & Other IncomeThe Group did not record revenue and/or other income in 2019 and 2018.

Operating Expenses

OPERATING RESULTSAs a result of the overall increase in total operating expenses, the Group's operating loss increased from EUR25.2 million in 2018 to EUR73.2 million in 2019.

NET FINANCIAL RESULT

NET RESULTAs a result of the above items, the loss for the year increased by EUR22.8 million to EUR52.6 million in 2019 versus a loss of EUR29.8 million in 2018. CASH FLOWSTotal cash and cash equivalents decreased by EUR30.8 million from EUR60.3 million at year-end 2018 to EUR29.5 million at the end of 2019. This decrease mainly results from the net operating cash outflow amounting to EUR48.3 million, capital expenses of EUR4.5 million and repayments of outstanding loans of EUR5.7 million, offset by the net proceeds of a share offering for a total amount of EUR25.3 million and cash balances of CytoSen for an amount of EUR3.1 million, which we acquired on June 5, 2019.

EQUITYThe Company's equity position amounted to EUR34.3 million at year-end 2019 versus EUR44.1 million at the end of 2018, a decrease of EUR9.8 million. The main drivers of this decrease are the loss for the year of EUR52.6 million offset by net proceeds of a share offering of EUR25.3 million in total and shares issued upon the acquisition of a business combination.Earnings per shareThe undiluted loss per share for 2019 increased to EUR 1.92 compared to EUR 1.46 in 2018.

Annual Report

The Annual Report 2019 is available on Kiadis Pharmas website.

Conference Call and PresentationTo participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:Standard International: +44 (0) 2071 928338Netherlands, Amsterdam: +31 (0) 207956614UK, London: +44 (0) 8444819752US, New York: +16467413167US, toll free: 18778709135

Event Plus Passcode: 4968027

A live audio webcast of the call can be accessed from the Events and Presentations section of the Companys website, https://ir.kiadis.com/events-and-presentations or at https://edge.media-server.com/mmc/p/6ctgdx37.

For more information, please contact:

About Kiadis Pharmas K-NK-Cell Therapies

Kiadis Pharmas K-NK platform is designed to deliver potent NK cells to help each patient, without the need for genetic engineering. Kiadis Pharmas programs consist of off-the-shelf and haploidentical donor NK-cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.

The Companys PM21 particle technology enables improved ex vivo expansion and activation of cytotoxic NK cells supporting multiple high-dose infusions. Kiadis Pharmas proprietary off-the-shelf NK-cell platform is based on NK cells from unique universal donors and can make NK-cell therapy product rapidly and economically available for a broad patient population across a potentially wide range of indications.

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Kiadis Pharma is developing K-NK002, which is administered as an adjunctive immunotherapeutic on top of HSCT, and K-NK003 for the treatment of relapse/refractory acute myeloid leukemia. In addition, Kiadis Pharma has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.

About Kiadis PharmaFounded in 1997, Kiadis Pharma is building a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and offices and activities across the United States, Kiadis Pharma is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life. The Companys shares are listed on the Euronext Amsterdam and Brussels under the ticker KDS. Learn more at http://www.kiadis.com.Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at kiadis.com.

Forward Looking StatementsCertain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharmas or, as appropriate, Kiadis Pharmas officers current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Kiadis Pharma announces annual results for the year ended December 31, 2019 - Yahoo Finance

A BRAVE boy who won the nation's heart in his battle against leukaemia gave his millions of fans a thumbs up after being discharged from hospital and declared cancer free.

Oscar Saxelby-Lee, 6, was diagnosed with an aggressive blood cancer in December 2018 after his parents noticed unusual bruising on his legs.

Doctors gave Oscar, from Worcester, just months to find a stem cell match to save his life which led parents Olivia Saxelby, 25, and Jamie Lee, 28, to launch a UK-wide appeal for donors.

Last March, a record-breaking 4,855 volunteers queued in the freezing rain after Oscar's Pitmaston Primary School in Worcester opened as a testing centre.

A suitable donor was finally found after a staggering 10,000 people were tested across the UK.

Just months later, Oscar's family faced further anguish when his rare T-cell acute lymphoblastic leukaemia returned.

But after a crowdfunding campaign raised 600,000, his family flew him to Singapore to undergo CAR-T therapy - a pioneering treatment not available on the NHS.

Oscar became only the second child in the world to have the treatment before having a second bone marrow transplant.

Now the boy's thrilled mum Olivia has confirmed he is out of hospital and cancer free.

In a touching picture, brave Oscar, nicknamed Ozzy Bear by his parents, posed in his car seat wearing a protective mask and giving a massive thumbs up.

Writing on the 'Hand in Hand for Oscar' Facebook page, followed by millions worldwide, she said: "He's only gone and done it!!!!!!!

"Thank you from the bottom of our hearts to our AMAZING team at National University Hospital - NUH, you have made miracles happen!

Delighted Olivia added: "We love you all!

"HOME SWEET HOME, WHEREVER IT WILL BE!"

Jen Kelly, director of the Grace Kelly Childhood Cancer Trust, who has kept in touch with the family, said:"They have now been in Singapore for six months and it is incredible that he is still cancer free and that his bone marrow transplant has gone well to date.

"We would like to say a big thank you to the people of Worcestershire for helping us give this lifesaving chance to Oscar and his family."

While Oscar is now out of hospital, he is still returning frequently to Singapore for treatment so will remain there for several more months before returning home to Worcester.

Live Blog

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Throughout his treatment, Oscar has kept in touch with his classmates and teachers from his hospital bed via an innovative robot - nicknamed "Ozzybot".

His headteacher Kate Wilcock, who organised the huge donor registration event and Ozzybot lessons, said: "Incredible news his last results are MRD negative, no disease.

"We are absolutely blown away - the dream has become a reality.

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Brave boy, 6, who won the nations heart as he battled leukaemia gives a thumbs up after being discharged f - The Sun

The Autologous Stem Cell and Non-Stem Cell Based Therapies market research encompasses an exhaustive analysis of the market outlook, framework, and socio-economic impacts. The report covers the accurate investigation of the market size, share, product footprint, revenue, and progress rate. Driven by primary and secondary researches, the Autologous Stem Cell and Non-Stem Cell Based Therapies market study offers reliable and authentic projections regarding the technical jargon.

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The major players profiled in this report include:U.S. STEM CELL, INC.Brainstorm Cell TherapeuticsCytoriDendreon CorporationFibrocellLion BiotechnologiesCaladrius BiosciencesOpexa TherapeuticsOrgenesisRegenexxGenzymeAntriaRegeneusMesoblastPluristem Therapeutics IncTigenixMed cell EuropeHolostemMiltenyi Biotec

The end users/applications and product categories analysis:On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-Embryonic Stem CellResident Cardiac Stem CellsAdult Bone MarrowDerived Stem CellsUmbilical Cord Blood Stem Cells

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Autologous Stem Cell and Non-Stem Cell Based Therapies for each application, including-Neurodegenerative DisordersAutoimmune Diseases Cancer and TumorsCardiovascular Diseases

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Objectives of the Autologous Stem Cell and Non-Stem Cell Based Therapies Market Study:

The Autologous Stem Cell and Non-Stem Cell Based Therapies market research focuses on the market structure and various factors (positive and negative) affecting the growth of the market. The study encloses a precise evaluation of the Autologous Stem Cell and Non-Stem Cell Based Therapies market, including growth rate, current scenario, and volume inflation prospects, on the basis of DROT and Porters Five Forces analyses. In addition, the Autologous Stem Cell and Non-Stem Cell Based Therapies market study provides reliable and authentic projections regarding the technical jargon.

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After reading the Autologous Stem Cell and Non-Stem Cell Based Therapies market report, readers can:

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market: Incredible Possibilities, Growth With Industry Study, Detailed Analysis And Forecast To...