StemCell Therapy

Paragon Biosciences, a life science innovator that creates, invests in and builds life science companies in biopharmaceuticals, cell and gene therapy and synthetic biology utilizing artificial intelligence, has launched CiRC Biosciences, a cell therapy company developing treatments for serious diseases with high, unmet needs with an initial focus on the eye."The addition of CiRC Biosciences to our portfolio builds upon our cell and gene therapy platform, an area that has tremendous potential to address serious genetic diseases," said Jeff Aronin, founder, chairman and chief executive officer, Paragon Biosciences. "CiRC Biosciences gives us the science to target retinal diseases that could lead to vision restoration with numerous other applications in the years ahead."CiRC Biosciences is currently advancing pre-clinical development of chemically induced retinal cells for vision restoration in Geographic Atrophy Age-Related Macular Degeneration (Dry AMD), which is the most common cause of irreversible vision loss over the age of 65, and advanced Retinitis Pigmentosa (RP), a genetic disorder that causes tunnel vision and eventual blindness. There are no U.S. Food & Drug Administration (FDA) approved treatments to restore vision loss in Dry AMD or RP.The company's novel mechanism of action is designed for direct chemical conversion of fibroblasts into other cell types using a cocktail of small molecules in an 11-day chemical conversion process. Pre-clinical studies have shown efficacy in blind mice that demonstrated vision restoration. CiRC Biosciences has provisional patent applications to protect its platform."Our technology transforms ordinary skin cells into specialized retinal cells using a cocktail of small molecules," said Sai Chavala, M.D., co-founder and chief scientific officer, CiRC Biosciences. "This process is potentially safer, quicker, more cost effective and easier to manufacturer than using traditional stem cells. Working with Paragon Biosciences to build and advance CiRC Biosciences provides us the opportunity to efficiently progress this technology through research and development stages.CiRC Biosciences first reported its discovery in the highly respected scientific journal Nature (April 15, 2020). A recently published New England Journal of Medicine article (Nov. 5, 2020) discussed CiRC's technology of using chemically induced cells to restore retinal function. The article concluded, "The new and emerging strategies for the rescue, regeneration, and replacement of photoreceptors suggest a bright future in the fight to preserve and restore vision in blinding eye diseases."The abstract in Nature is available here.Access to the NEJM article is available here.

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Paragon Biosciences Expands Cell And Gene Therapy Platform - Contract Pharma

PROVIDENCE, R.I.[Brown University] New research provides insights into the treatment of Christianson syndrome (CS), an X-linked genetic disease characterized by reduced brain growth after birth, intellectual disability, epilepsy and difficulties with balance and speech.

One of the major challenges in developing treatments for human brain disorders, like CS, is developing an experimental system for testing potential therapeutics on human neurons, said study senior author Dr. Eric Morrow, an associate professor of molecular biology, neuroscience and psychiatry at Brown University. In recent years, advanced stem cell therapies that use tissues from patients have provided powerful new approaches for engineering human neurons from the patients themselves, who may undergo the treatment in the future.

For the study, published in Science Translational Medicine on Feb. 10, 2021, Morrow and his colleagues obtained blood samples from five CS patients and the patients unaffected brothers. They then reprogrammed these blood cells into stem cells, and these stem cells were converted into neurons in a petri dish. As a result, they obtained neurons that were representative of those from CS patients, and they used these neurons to test treatments.

Morrow who directs the Center for Translational Neuroscience at the Carney Institute for Brain Science and the Brown Institute for Translational Science said the team also used a new gene-editing approach that employs CRISPR-Cas9 technologies to correct patient mutations back to a healthy gene sequence.

CS is caused by a mutation in a gene encoding for NHE6, a protein that helps regulate acid levels within cell structures called endosomes. Past research suggests that the loss of NHE6 causes endosomes to become overly acidic, which disrupts the abilities of developing neurons to branch out and form connections in the growing brain.

Loss of this important protein can arise from a variety of gene mutations in patients. The majority of CS mutations are called nonsense mutations, which prevent NHE6 from being produced at all; four of the five CS patients involved in this study exhibited this class of mutation. However, some CS patients exhibit missense mutations. Individuals with missense mutations still have some NHE6, but it is produced in smaller amounts, and the protein fails to function as it should.

The research team tested two main forms of treatment on the stem-cell-derived neurons: first, gene transfer, which involves adding a healthy NHE6 gene into the cell; and second, administration of trophic factors, which are substances that promote neuron growth and encourage neurons to develop connections with other neurons. The researchers found that the neurons response to treatment depended on the class of mutation present.

The gene transfer studies, which may represent the first steps toward developing gene therapy, were successful in neurons with nonsense mutations. After the researchers inserted a functional NHE6 gene into nonsense-mutation CS neurons, the neurons branched out properly. In neurons with missense mutations, however, gene transfer failed completely. Further tests suggested that the abnormal NHE6 produced as a result of missense mutations may interfere with normal NHE6, thereby rendering gene transfer therapy ineffective in patient cells with these mutations.

In contrast, administration of trophic factors, such as brain-derived neurotrophic factor (BDNF) and insulin-like growth factor-1 (IGF-1), successfully promoted proper branching in all the CS neurons studied, regardless of mutation type.

While these initial results are encouraging, Morrow hopes that future studies will examine these treatments in animal models.

Our results provide an initial proof-of-concept for these treatment strategies, indicating that they should be studied further, he said. However, we may ultimately need to pay close attention to the class of mutation that a patient has when we choose a specific treatment.

In addition to Morrow, the research team included scientists from Brown University, the University of South Carolina and the Icahn School of Medicine at Mount Sinai. The study was supported by multiple grants from the National Institutes of Health as well as a number of awards from foundations and academic institutions.

This news story was authored by contributing science writerKerry Benson.

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Neurons from patient blood cells enable researchers to test treatments for genetic brain disease - Brown University

DetailsCategory: DNA RNA and CellsPublished on Monday, 08 February 2021 16:09Hits: 412

- Phase 1/2 trial expected to commence in first half of 2021

- Company has three INDs cleared for rare monogenic CNS disorders

PHILADELPHIA, PA, USA I February 08, 2021 I Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBKR03, an adeno-associated virus (AAV)-delivery gene therapy being studied for the treatment of early infantile Krabbe disease (Globoid Cell Leukodystrophy). Currently, there are no approved disease-modifying therapies available for Krabbe disease, a rare lysosomal storage disease that most often presents early in a childs life, resulting in rapid progressive damage to both the brain and peripheral nervous system and mortality by two years of age. Underscoring the urgent medical need in the patient population, the FDA has previously granted Passage Bio both Orphan Drug and Rare Pediatric Disease designations for PBKR03 for treatment in Krabbe disease.

As part of our commitment to deliver a transformative, one-time gene therapy to the children and their families who suffer from the devastating effects of Krabbe disease, we are excited to advance toward clinically evaluating the potential life-changing benefits of PBKR03, said Bruce Goldsmith, Ph.D., chief executive officer of Passage Bio. The FDA clearance of our IND for PBKR03 is an important milestone for Passage Bio, paving the way for the start of our third clinical program in rare monogenic CNS disorders in the first half of 2021. Having solidified our clinical trial preparedness and manufacturing readiness during the past year, we are well-positioned to move with urgency to advance PBKR03 into the clinic.

PBKR03 utilizes a next-generation proprietary AAV capsid to deliver, through intra-cisterna magna (ICM) administration, a functional GALC gene to Krabbe patients with mutations in the gene that codes for galactosylceramidase (GAL-C). Low GAL-C activity results in accumulation of psychosine which is toxic to the myelin-producing oligodendrocytes of the CNS and Schwann cells in the periphery, resulting in damage to both the central and peripheral nervous systems. PBKR03 has the potential to treat both the central nervous system and peripheral nerve manifestations observed in Krabbe disease patients.

Compelling preclinical data support advancement into clinical trials

PBKR03 is supported by extensive preclinical studies, conducted by our collaborator, the University of Pennsylvanias Gene Therapy Program, showing meaningful transduction of both the central and peripheral nervous system in animal models, with restoration of myelination in the brain and peripheral nerves. In a naturally occurring Krabbe animal model, a single ICM injection of an AAVhu68 capsid containing the normal canine GALC gene showed normalization of GALC activity, reduction of cerebral spinal fluid psychosine levels, normalization of peripheral nerve conduction velocity, improvement in brain myelination, reduction in brain inflammation and increased survival.

Phase 1/2 study anticipated for 1H21

Passage Bio expects to initiate a Phase1/2 clinical trial for PBKR03 in the first half of 2021. The trial is designed as a dose escalation study of a single ICM dose of PBKR03 in pediatric subjects with early infantile Krabbe disease. The primary endpoint of the Phase 1/2 study is safety and tolerability; secondary endpoints include CSF and serum GALC levels, disease biomarkers, and clinical outcome measures. Initial data from the trial is anticipated to potentially readout in late 2021 or early 2022, depending on the timing of when the first patient is treated in the study.

PENN Financial Disclosure

The University of Pennsylvania (Penn) and its Gene Therapy Program receives sponsored research funding from Passage Bio, and Penn has licensed intellectual property to Passage Bio that may result in future financial returns to Penn.

About Krabbe Disease

Krabbe disease is a rare and often life-threatening lysosomal storage disease caused by mutations in the GALC gene, which encodes galactosylceramidase, an enzyme that breaks down galactosylceramide and psychosine. Without adequate levels of galactosylceramidase, psychosine accumulates, causing widespread death of myelin-producing cells and progressive damage to nerves in both the brain and peripheral tissues. The early infantile form of the disease is the most severe and common, typically manifesting before six months of age and accounting for 60 percent to 70 percent of diagnoses. In these patients, the disease course is highly predictable and rapidly progresses to include loss of acquired milestones, staring episodes, apnea, peripheral neuropathy, severe weakness, unresponsiveness to stimuli, seizures, blindness, deafness and eventual death by two years of age. Late infantile patients, defined by onset between seven to twelve months of age, present similar symptoms and have a median survival of approximately five years from onset of symptoms. The estimated worldwide incidence of Krabbe disease is 2.6 in 100,000 births, which is higher than reported due to lack of adequate screening at birth.

About Passage Bio

At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvanias Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with enhanced access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at http://www.passagebio.com.

SOURCE: Passage Bio

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FDA Clears IND Application for Passage Bio's Gene Therapy Candidate PBKR03 for Treatment of Patients with Early Infantile Krabbe Disease, A Rare...

New York, Feb. 05, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Gene Therapy Market by Therapeutic Approach, Type of Gene Therapy, Type of Vectors Used, Therapeutic Areas, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2020-2030" - https://www.reportlinker.com/p06020737/?utm_source=GNW Considering the current pace of research and product development activity in this field, experts believe that the number of clinical research initiatives involving gene therapies are likely to grow by 17% annually. In this context, the USFDA released a notification, mentioning that it now expects to receive twice as many gene therapy applications each year, starting 2020. Despite the ongoing pandemic, it is worth highlighting that gene therapy companies raised approximately USD 5.5 billion in capital investments, in 2020 alone. This is indicative of the promising therapeutic potential of this emerging class of pharmacological interventions, which has led investors to bet heavily on the success of different gene therapy candidates in the long term.

Several technology platforms are currently available for discovery and development of various types of gene therapies. In fact, advances in bioanalytical methods (such as genome sequencing), and genome editing and manipulation technologies (such as molecular switches), have enabled the development of novel therapy development tools / platforms. In fact, technology licensing is a lucrative source of income for stakeholders in this industry, particularly for those with proprietary gene editing platforms. Given the growing demand for interventions that focus on the amelioration of the underlying (genetic) causes of diseases, it is expected that the gene therapy pipeline will continue to steadily expand. Moreover, promising results from ongoing clinical research initiatives are likely to bring in more investments to support therapy product development initiatives in this domain. Therefore, we are led to believe that the global gene therapy market is poised to witness significant growth in the foreseen future.

SCOPE OF THE REPORT The Gene Therapy Market (4th Edition) by Therapeutic Approach (Gene Augmentation, Oncolytic Viral Therapy, Immunotherapy and Others), Type of Gene Therapy (Ex vivo and In vivo), Type of Vectors used (Adeno Associated Virus, Adenovirus, Herpes Simplex Virus, Lentivirus, Plasmid DNA, Retrovirus and Others), Target Therapeutic Areas (Autoimmune Disorders, Cardiovascular Diseases, Dermatological Disorders, Genetic Disorders, Hematological Disorders, Metabolic Disorders, Muscle-related Diseases, Oncological Disorders, Ophthalmic Diseases and Others), Route of Administration (Intraarticular, Intracerebellar, Intradermal, Intramuscular, Intratumoral, Intravenous, Intravesical, Intravitreal, Subretinal and Others), and Key Geographical Regions (US, EU5 and rest of the world): Industry Trends and Global Forecasts, 2020-2030 report features an extensive study of the current market landscape of gene therapies, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies, immunotherapies and gene editing therapies. The study also features an elaborate discussion on the future potential of this evolving market.

Amongst other elements, the report features: - A detailed review of the overall market landscape of gene therapies and gene editing therapies, including information on phase of development (marketed, clinical, preclinical and discovery) of pipeline candidates, key therapeutic areas (autoimmune disorders, cardiovascular diseases, dermatological disorders, genetic disorders, hematological disorders, immunological disorders, infectious diseases, inflammatory disorders, liver diseases, metabolic disorders, muscle-related diseases, nervous system disorders, oncological disorders, ophthalmic diseases and others), target disease indication(s), type of vector used, type of gene, therapeutic approach (gene augmentation, oncolytic viral therapy and others), type of gene therapy (ex vivo and in vivo), route of administration and special drug designation(s) awarded (if any). - A detailed review of the players engaged in the development of gene therapies, along with information on their year of establishment, company size, location of headquarters, regional landscape and key players engaged in this domain. - An elaborate discussion on the various types of viral and non-viral vectors, along with information on design, manufacturing requirements, advantages and limitations of currently available gene delivery vectors. - A discussion on the regulatory landscape related to gene therapies across various geographies, namely North America (the US and Canada), Europe and Asia-Pacific (Australia, China, Hong Kong, Japan and South Korea), providing details related to the various challenges associated with obtaining reimbursements for gene therapies. - Detailed profiles of marketed and late stage (phase II/III and above) gene therapies, including development timeline of the therapy, information on the current development status, mechanism of action, affiliated technology, strength of patent portfolio, dosage and manufacturing details, as well as details related to the developer company. - An elaborate discussion on the various commercialization strategies that can be adopted by drug developers across different stages of therapy development, including prior to drug launch, at / during drug launch and post-marketing. - A review of the various emerging technologies and therapy development platforms that are being used to design and manufacture gene therapies, featuring detailed profiles of technologies that were / are being used for the development of four or more products / product candidates. - An in-depth analysis of various patents that have been filed / granted related to gene therapies and gene editing therapies, since 2016. The analysis assesses several relevant parameters associated with the patents, including type of patent (granted patents, patent applications and others), publication year, regional applicability, CPC symbols, emerging focus areas, leading industry players (in terms of the number of patents filed / granted), and patent valuation. - A detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2020, based on several relevant parameters, such as year of agreement, type of deal, geographical location of the companies involved, key value drivers, highest phase of development of the acquired company product and target therapeutic area. - An analysis of the investments made at various stages of development in companies that are focused in this area, between 2015-2020, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other equity offerings. - A detailed geographical clinical trial analysis of completed, ongoing and planned studies of numerous gene therapies, based on various relevant parameters, such as trial registration year, trial status, trial phase, target therapeutic area, geography, type of sponsor, prominent treatment sites and enrolled patient population. - An analysis of the various factors that are likely to influence the pricing of gene therapies, featuring different models / approaches that may be adopted by manufacturers to decide the prices of these therapies. - An analysis of the big biopharma players engaged in this domain, featuring a heat map based on parameters, such as number of gene therapies under development, funding information, partnership activity and strength of patent portfolio. - An informed estimate of the annual demand for gene therapies, taking into account the marketed gene-based therapies and clinical studies evaluating gene therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength. - A case study on the prevalent and emerging trends related to vector manufacturing, along with information on companies offering contract services for manufacturing vectors. The study also includes a detailed discussion on the manufacturing processes associated with various types of vectors. - A discussion on the various operating models adopted by gene therapy developers for supply chain management, highlighting the stakeholders involved, factors affecting the supply of therapeutic products and challenges encountered by developers across the different stages of the gene therapy supply chain.

One of the key objectives of the report was to estimate the existing market size and the future opportunity associated with gene therapies, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2020-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] therapeutic approach (gene augmentation, oncolytic viral therapy, immunotherapy and others), [B] type of gene therapy (ex vivo and in vivo), [C] type of vectors used (adeno associated virus, adenovirus, herpes simplex virus, lentivirus, plasmid DNA, retrovirus and others), [D] target therapeutic areas (autoimmune disorders, cardiovascular diseases, dermatological disorders, genetic disorders, hematological disorders, metabolic disorders, muscle-related diseases, oncological disorders, ophthalmic diseases and others), [E] route of administration (intraarticular, intracerebellar, intradermal, intramuscular, intratumoral, intravenous, intravesical, intravitreal, subretinal and others), and [F] key geographical regions (US, EU5 and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industrys growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: - Adam Rogers (CEO, Hemera Biosciences) - Al Hawkins (CEO, Milo Biotechnology) - Buel Dan Rodgers (Founder & CEO, AAVogen) - Christopher Reinhard (CEO and Chairman, Gene Therapeutics (previously known as Cardium Therapeutics)) - Michael Triplett (CEO, Myonexus Therapeutics) - Robert Jan Lamers (CEO, Arthrogen) - Ryo Kubota (CEO, Chairman & President, Acucela) - Tom Wilton (CBO, LogicBio Therapeutics) - Jeffrey Hung (CCO, Vigene Biosciences) - Cedric Szpirer (Executive & Scientific Director, Delphi Genetics) - Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) - Molly Cameron (Corporate Communications Manager, Orchard Therapeutics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include - Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts views

While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED - Who are the leading industry players engaged in the development of gene therapies? - How many gene therapy candidates are present in the current development pipeline? Which key disease indications are targeted by such products? - Which types of vectors are most commonly used for effective delivery of gene therapies? - What are the key regulatory requirements for gene therapy approval, across various geographies? - Which commercialization strategies are most commonly adopted by gene therapy developers, across different stages of development? - What are the different pricing models and reimbursement strategies currently being adopted for gene therapies? - What are the various technology platforms that are either available in the market or are being designed for the development of gene therapies? - Who are the key CMOs / CDMOs engaged in supplying viral / plasmid vectors for gene therapy development? - What are the key value drivers of the merger and acquisition activity in the gene therapy industry? - Who are the key stakeholders that have actively made investments in the gene therapy domain? - Which are the most active trial sites (in terms of number of clinical studies being conducted) related to this domain? - How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES Chapter 2 provides an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the market for gene therapies and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general overview of gene therapies, including a discussion on their historical background. It further highlights the different types of gene therapies (namely somatic and germline therapies, and in vivo and ex vivo therapies), potential application areas of such products and route of administration of these therapeutic interventions. In addition, it provides information on the concept of gene editing, highlighting key historical milestones, applications and various techniques used for gene editing. The also chapter includes a discussion on the advantages and disadvantages associated with gene therapies. Further, it features a brief discussion on the ethical and social concerns related to gene therapies, while highlighting future constraints and challenges related to the manufacturing and commercial viability of such product candidates.

Chapter 4 provides a general introduction to the various types of viral and non-viral gene delivery vectors. It includes a detailed discussion on the design, manufacturing requirements, advantages and limitations of currently available vectors.

Chapter 5 features a detailed discussion on the regulatory landscape related to gene therapies across various geographies, such as the US, Canada, Europe, Australia, China, Hong Kong, Japan and South Korea. Further, it highlights an emerging concept of reimbursement which was recently adopted by multiple gene therapy developers, along with a discussion on several issues associated with reimbursement of gene therapies.

Chapter 6 includes information on over 800 gene therapies and gene editing therapies that are currently approved or are in different stages of development. It features a detailed analysis of pipeline molecules, based on several relevant parameters, such as key therapeutic areas (autoimmune disorders, cardiovascular diseases, dermatological disorders, genetic disorders, hematological disorders, immunological disorders, infectious diseases, inflammatory disorders, liver diseases, metabolic disorders, muscle-related diseases, nervous system disorders, oncological disorders, ophthalmic diseases and others), target disease indication(s), phase of development (marketed, clinical, preclinical and discovery), type of vector used, type of gene, type of gene therapy (ex vivo and in vivo), therapeutic approach (gene augmentation, oncolytic viral therapy and others), route of administration and special drug designation (if any). Further, we have presented a grid analysis of gene therapies based on phase of development, therapeutic area and therapeutic approach.

Chapter 7 provides a detailed review of the players engaged in the development of gene therapies, along with information on their year of establishment, company size, location of headquarters, regional landscape and key players engaged in this domain. Further, we have presented a logo landscape of product developers in North America, Europe and the Asia-Pacific region on the basis of company size.

Chapter 8 provides detailed profiles of marketed gene therapies. Each profile includes information about the innovator company, its product pipeline (focused on gene therapy only), development timeline of the therapy, its mechanism of action, target indication, current status of development, details related to manufacturing, dosage and sales, the companys patent portfolio and collaborations focused on its gene therapy product / technology.

Chapter 9 features an elaborate discussion on the various strategies that can be adopted by therapy developers across key commercialization stages, including prior to drug launch, during drug launch and post-launch. In addition, it presents an in-depth analysis of the key commercialization strategies that have been adopted by developers of gene therapies approved during the period 2015-2020.

Chapter 10 provides detailed profiles of drugs that are in advanced stages of clinical development (phase II/III and above). Each drug profile provides information on the current developmental status of the drug, its route of administration, developers, primary target indication, special drug designation received, target gene, dosage, mechanism of action, technology, patent portfolio, clinical trials and collaborations (if any).

Chapter 11 provides a list of technology platforms that are either available in the market or in the process of being designed for the development of gene therapies. In addition, it features brief profiles of some of the key technologies. Each profile features details on the various pipeline molecules that have been / are being developed using the technology, its advantages and the partnerships that have been established related to the technology platform. Further, the chapter includes detailed discussions on various novel and innovative technologies, along with brief information about key technology providers.

Chapter 12 highlights the potential target indications (segregated by therapeutic areas) that are currently the prime focus of companies developing gene therapies. These include genetic disorders, metabolic disorders, nervous system disorders, oncological disorders and ophthalmic diseases.

Chapter 13 provides an overview of the various patents that have been filed / granted in relation to gene therapy and gene editing technologies. It also features a detailed analysis, highlighting the prevalent trends related to type of patent, publication year, regional applicability, CPC symbols, emerging areas and leading industry players (in terms of number of patents filed). In addition, it features a competitive benchmarking analysis of the patent portfolios of leading industry players and patent valuation. For the purpose of this analysis, we have taken into consideration patents that have been filed / granted since 2016.

Chapter 14 features a detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2020, based on several relevant parameters, such as year of agreement, type of deal, geographical location of the companies involved, key value drivers, highest phase of development of the acquired company product and target therapeutic area.

Chapter 15 presents details on various funding instances, investments and grants reported within the gene therapy domain. The chapter includes information on various types of investments (such as venture capital financing, debt financing, grants, capital raised from IPO and subsequent offerings) received by the companies between 2015 and 2020, highlighting the growing interest of the venture capital community and other strategic investors in this market.

Chapter 16 presents a detailed, geographical clinical trial analysis of completed, ongoing and planned studies focused on gene therapies, based on various relevant parameters, such as trial registration year, trial status, trial phase, target therapeutic area, geography, type of sponsor, prominent treatment sites and enrolled patient population.

Chapter 17 highlights our views on the various factors that may be taken into consideration while deciding the price of a gene therapy. It features discussions on different pricing models / approaches, based on the size of the target population, which a pharmaceutical company may choose to adopt in order to decide the price of its proprietary products.

Chapter 18 highlights top big biopharma players engaged in the field of gene therapy, featuring a heat map analysis based on several parameters, including therapeutic area, type of vector used, therapeutic approach and type of gene therapy.

Chapter 19 features an informed estimate of the annual demand for gene therapies, taking into account the marketed gene-based therapies and clinical studies evaluating gene therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength.

Chapter 20 presents an elaborate market forecast analysis, highlighting the future potential of the market till the year 2030. It also includes future sales projections of gene therapies that are either marketed or in advanced stages of clinical development (phase II/III and above). Sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of [A] therapeutic approach (gene augmentation, oncolytic viral therapy, immunotherapy and others), [B] type of gene therapy (ex vivo and in vivo), [C] type of vector used (adeno associated virus, adenovirus, herpes simplex virus, lentivirus, plasmid DNA, retrovirus and others), [D] target therapeutic area (autoimmune disorders, cardiovascular diseases, dermatological disorders, genetic disorders, hematological disorders, metabolic disorders, muscle-related diseases, oncological disorders, ophthalmic diseases and others), [E] route of administration (intraarticular, intracerebellar, intradermal, intramuscular, intratumoral, intravenous, intravesical, intravitreal, subretinal and others), and [F] key geographical regions (US, EU5 and rest of the world).

Chapter 21 provides insights on viral vector manufacturing, highlighting the steps and processes related to manufacturing and bioprocessing of vectors. In addition, it features the challenges that exist in this domain. Further, the chapter provides details on various players that offer contract manufacturing services for viral and plasmid vectors.

Chapter 22 provides a glimpse of the gene therapy supply chain. It discusses the steps for implementing a robust model and provides information related to the global regulations for supply chain. Moreover, the chapter discusses the challenges associated with supply chain of gene therapies. In addition, it features the technological solutions that can be adopted for the management of gene therapy supply chain.

Chapter 23 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the gene therapy market.

Chapter 24 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Adam Rogers (CEO, Hemera Biosciences), Al Hawkins (CEO, Milo Biotechnology), Buel Dan Rodgers (Founder & CEO, AAVogen), Christopher Reinhard (CEO & Chairman, Gene Therapeutics (previously known as Cardium Therapeutics)), Michael Triplett (CEO, Myonexus Therapeutics), Robert Jan Lamers (CEO, Arthrogen), Ryo Kubota (CEO, Chairman & President, Acucela), Tom Wilton (CBO, LogicBio Therapeutics), Jeffrey Hung (CCO, Vigene Biosciences), Cedric Szpirer (Executive & Scientific Director, Delphi Genetics), Marco Schmeer (Project Manager) & Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Molly Cameron (Corporate Communications Manager, Orchard Therapeutics). In addition, a brief profile of each company has been provided.

Chapter 25 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 26 is an appendix, which contains a list of companies and organizations mentioned in this report.Read the full report: https://www.reportlinker.com/p06020737/?utm_source=GNW

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Gene Therapy Market by Therapeutic Approach, Type of Gene Therapy, Type of Vectors Used, Therapeutic Areas, Route of Administration, and Key...

Breyanzi (lisocabtagene maraleucel) was approved on the 54 percent complete remission rate achieved in diffuse large B-cell lymphoma trials.

Breyanzi (lisocabtagene maraleucel), a chimeric antigen receptor (CAR) T cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or relapsed, after at least two other types of systemic treatment has been approved by the US Food and Drug Administration (FDA).

According to the agency, Breyanzi is the third gene therapy approved in the US for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

Todays approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes, commented Dr Peter Marks, director of the FDAs Center for Biologics Evaluation and Research. Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.

DLBCL is the most common type of non-Hodgkin lymphoma in adults. Approximately 77,000 new cases of non-Hodgkin lymphoma are diagnosed in the US each year, with DLBCL accounting for around a third of newly diagnosed cases.

Breyanzi is customised for each patient; their T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates targeting and killing of the lymphoma cells. Once the cells are modified, they are infused back into the patient.

The safety and efficacy of the treatment were established in a multi-centre clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment with Breyanzi was 54 percent.

The treatment can cause severe side effects, including cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T cells, causing high fever and flu-like symptoms and neurologic toxicities. Both CRS and neurological events can be life-threatening, so the therapy is being approved with a risk evaluation and mitigation strategy (REMS) which includes elements to assure safe use (ETASU).

The requirements include, among other things, that healthcare facilities that dispense Breyanzi be specially certified, with staff involved in the prescribing, dispensing or administering of the treatment being trained to recognise and manage the risks of CRS and neurologic toxicities.

Other side effects include hypersensitivity reactions, serious infections, low blood cell counts and a weakened immune system. According to the FDA, side effects generally appear within the first one to two weeks following treatment, but some side effects may occur later.

To further evaluate the long-term safety, the FDA is also requiring the manufacturer to conduct a post-marketing observational study involving patients treated with Breyanzi.

The approval was granted to Juno Therapeutics Inc., a Bristol-Myers Squibb Company.

View original post here:
FDA approves third gene therapy for large B-cell lymphoma - European Pharmaceutical Review

REDWOOD CITY, Calif., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the presentation of data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration (AMD). These data were previously presented as part of a corporate update on Saturday, November 14, 2020.

Oral Presentation Title: Intravitreal Gene Therapy for Exudative AMD and Diabetic RetinopathyDate and Time: Saturday, February 13, 2021 at 9:30 am ETSession V: Gene Therapy for Exudative AMD and Diabetic RetinopathyPresenter: Arshad M. Khanani, M.D., M.A., Director of Clinical Research, Sierra Eye Associates

A copy of this presentation will be available as the presentation begins in the publications and presentation section of Adverums website.

About Adverum BiotechnologiesAdverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visitwww.adverum.com.

Read more:
Adverum to Present Data from the OPTIC Phase 1 Trial with ADVM-022 Intravitreal Gene Therapy in Wet AMD at the Angiogenesis, Exudation, and...

Gene therapy companies have been under pressure lately, but Orchard Therapeutics got a lift yesterday from promising early data with its mucopolysaccharidosis type I candidateOTL-203.

The company is seeking to supersede the current standard of care, enzyme-replacement therapy or bone marrow transplant. But other gene therapy contenders are not too far behind, notablyRegenxbio, which in December started a proof-of-concept study of its rival project, RGX-111.

Good IDUA

Both projects seek to deliver the -l-iduronidase (IDUA) gene, which is mutated in MPS-I, leading to a deficiency of the IDUA enzyme. This enzyme usually breaks down glycosaminoglycans (GAGs), so in MPS-I patients these build up, causing tissue and organ damage. Symptoms of MSP-I, also known as Hurler syndrome, include cognitive impairment and skeletal deformity; if left untreated, patients rarely survive beyond the age of 10.

And both OTL-203 and RGX-111 are designed as one-time therapies, whereas the current enzyme replacement, Biomarin/Sanofis Aldurazyme, is given intravenously once a week.

However, the gene therapy candidates go about restoring IDUA enzyme activity in different ways. OTL-203 uses hematopoietic stem cells taken from the patient, then genetically modified using a lentiviral vector to express the IDUA gene, before being reinfused.

RGX-111, meanwhile, uses an adeno-associated viral vector to deliver the gene directly to the brain, getting around a central problem with Aldurazyme, which cannot cross the blood-brain barrier.

Getting into the brain should not be a problem for OTL-203 either, Orchards head of medical affairs, Leslie Meltzer, told Evaluate Vantage. She explained that hematopoietic stem cells naturally cross the blood-brain barrier and, once in the CNS, differentiate into a microglial-like cell.

This claim appears to be supported by the latest data, which admittedly come in just a handful of subjects. The eight-patient phase I/II trial, presented at the World Symposium yesterday, found increases in the IDUA enzyme in patients blood and cerebrospinal fluid. There was also a decrease in GAGs in the CSF and urine.

Encouragingly, this activity appears to have translated into a clinical benefit: all eight patients showed stable cognitive scores and stable motor function versus baseline, as well as growth in the normal range for patients age.

Its a progressive disease, so youd expect these things to worsen over time, but the fact they continued to be stable is very promising, Ms Meltzer said.She admitted that the data were early, with only around a year of follow-up on most of the clinical endpoints.

Orchard plans to start a registrational study by the end of this year.Ms Meltzer would not give any details ondesign, saying this would be finalised after feedback from regulators.

Regenxbios proof-of-concept study of RGX-111 is due to complete in November, putting the project about a year behind OTL-203.

One candidate that will go no further is Sangamos SB-318. The company reported disappointing data with the in vivo zinc finger nuclease genome-editing project two years ago, and has since said it would focus on second-generation zinc finger projects.

Still, even two gene therapies might be too many for an ultra-rare disease like MPS-I, which affects just one in 100,000 people. Asked whether this market could support more than one gene therapy, Ms Meltzer said newborn screening recently implemented in countries including the UScould lead to a revision of that estimate.

But, as in other rare disorders that have attracted several gene therapy players, a battle over a limited patient pool could be shaping up.

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World Symposium Orchard leads the crop of Hurler syndrome hopefuls - Vantage

Article reflects Companys leadership and innovation in scalable, reproducible manufacture of adeno-associated virus (AAV)-based gene therapies

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company focused on developing adeno-associated virus (AAV) based gene therapies for the treatment of rare inherited diseases, announced that Sue Washer, President & Chief Executive Officer and Dave Knop, Vice President of Process Development, have been awarded first place in the BioProcess International (BPI) magazine inaugural Readers Choice Awards program, cell and gene therapies category, for their article, Viral-Vectored Gene Therapies: Harnessing Their Potential Through Scalable, Reproducible Manufacturing Processes.

High-productivity approaches to AAV manufacturing processes, like AGTCs HSV-helper based platform, will be crucial if we are to address the unmet clinical need growing across a variety of indications, said AGTC President and CEO, Sue Washer. There is no question that investing in the manufacturing process is imperative and our early commitment in this area has put AGTC in a strong position with respect to the purity and quality needed for late stage development and commercialization.

Concentrating on articles published from September 2019 through June 2020, and using rankings based on views, engagement, and download rates, BioProcess International identified the four most popular articles within each of its six pillars of bioprocessing coverage. The AGTC authors article received the highest number of votes from BPI readers, who ranked the nominees in terms of their innovativeness, presentability and applicability.

The eBook featuring the first-place article by Washer and Knop, as well as summarized versions of the second- and third-place articles, are available by visiting: https://bioprocessintl.com/wp-content/uploads/2020/11/18-11-eBook-RCA-CellGeneTherapies.pdf.

About AGTCAGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. The Companys most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Its preclinical programs build on the Companys industry-leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders.

IR/PR CONTACTS:David Carey (IR) or Glenn Silver (PR)Lazar FINN PartnersT: (212) 867-1768 or (646) 871-8485david.carey@finnpartners.com or glenn.silver@finnpartners.com

Corporate Contact:Bill SullivanChief Financial OfficerApplied Genetic Technologies CorporationT: (617) 843-5728bsullivan@agtc.com

Stephen PotterChief Business OfficerApplied Genetic Technologies CorporationT: (617) 413-2754spotter@agtc.com

See the original post:
AGTC Executives Awarded First Place in the BioProcess International Reader's Choice Awards, Cell & Gene Therapies Category - GlobeNewswire

NEW YORK, Feb. 11, 2021 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today highlighted its presence at the 2021 Transplantation & Cellular Therapy (TCT) Annual Meeting, which is being held virtually from February 8th 12th. The TCT meeting organizes thousands of transplant professionals from over five hundred transplant centers worldwide and is a seminal event for Actinium given its focus on targeted conditioning for bone marrow transplant (BMT), CAR-T and other adoptive cell therapies and gene therapy. At TCT, Actinium's pivotal Phase 3 trial SIERRA trial for Iomab-B was featured in 2 oral presentations, as well as CME event focused on AML and BMT and in investigator interactions led by Actinium's clinical development and medical affairs teams.

Dr. Mark Berger, Actinium's Chief Medical Officer, said, "TCT is the ideal venue to showcase Actinium's Iomab-B and Iomab-ACT targeted conditioning programs given the concentrated audience of thought leaders in these fields that TCT brings together. The timing of TCT is also ideal as it follows shortly after ASH resulting in a data rich period for Actinium that drives investigator interest. This is particularly the case this year as we have built strong momentum in SIERRA following positive data from 75% enrollment featured in 2 oral presentations at ASH and now in 2 oral presentations at this year's TCT, which has driven high levels of investigator and referring physician interactions. We have coupled this with bolstered outreach efforts, which will continue beyond TCT, that have resulted in new site activation despite the advanced stage of SIERRA and robust enrollment rates that give us great confidence in completing SIERRA enrollment rapidly."

Summary data presented in TCT oral presentations include:

-100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician's choice of salvage therapy on the control arm- 79% of all patients enrolled on SIERRA were able to proceed to BMT despite being a patient population not considered eligible for BMT with standard approaches-Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events

TCT Oral Presentation: Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered

Phase 3 SIERRA 75% Enrollment Results

Baseline Characteristics

Iomab-B Arm(N=56)

Conventional Care (CC) Arm(N=57)

Age (yrs, median, range)

63 (55-77)

65 (55-77)

Cytogenetic and Molecular Risk1, 2

Favorable: 4%Intermediate: 35%

Adverse: 61%

Favorable: 5%

Intermediate: 32%

Adverse: 63%

% TransplantedIntent-to-Treat Group

88% (49/56)

18% (10/57)

64% (30/47)

Results

Underwent Iomab-B based Conditioning and HCT (N=49)3

Achieved CR and received standard of care HCT (N=10)

Randomized to Conventional Care and Crossed Over to Iomab-B with HCT (N=30)4

Cross-over Rate

n/a

n/a

Received Therapeutic Dose of Iomab-B (N=30)

Transplanted (N=30)

64% (30/47)

% Transplanted

100% (49/49)

18% (10/57)

100% (30/30)

% Marrow Blast @ randomization (median, range)

29% (4-95)5

20% (5-97)

28% (6-87)

Days to ANC Engraftment

14 (9-22)6

17 (13-83)7

14 (10-37)8

Days to Platelet Engraftment

18 (4-39)6

22 (8-35)7

19 (1-38)8

Days to HCT (Post Randomization)

30 (23-60)

67 (52-104)

62 (36-100)9

Myeloablative Dose Delivered to Bone Marrow

14.7 (4.6-32) Gv

n/a

15.5 (6.3-42) Gv

592 (313-1013) mCi

646 (354-1027) mCi

100-day non-Relapse Transplant-Related Mortality

4%

(2/45 Evaluable)

20%

(2/10 Evaluable)

10.7%

(3/28 Evaluable)

1) Iomab-B arm: data unavailable (4) and patient was excluded (1)

2) Per NCCN guidelines version 3. 2020

3) No therapy dose (7) due to: declining KPS (4), Infusion reaction (1), unfavorable biodistribution (1), post- randomization eligibility (1). Two (2) did not receive DI and five (5) received DI without proceeding to TI.

4) Thirteen (13) patients ineligible for crossover due to: hospice care/progression (4), declined/ineligible for HCT (5), died pre-crossover (4). Additionally, four (4) patients were eligible for crossover and did not receive Iomab-B due to declining KPS.

5) One (1) patient with 4% blasts in the marrow had circulating AML blasts

6) ANC engraftment data not available (4), platelet engraftment data not available (7)

7) ANC and platelet engraftment data not available (1)

8) ANC engraftment data not available (1), platelet engraftment data not available (2)

9) One (1) patient at 161 days had delayed transplant due to infection & respiratory failure, received Iomab & transplant when stable, not included in range

https://tct.confex.com/tct/2021/meetingapp.cgi/Paper/16878

TCT Oral Presentation: Myeloablative Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Spares the GI Tract and Has Low Incidence of Severe Mucositis, Febrile Neutropenia and Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Adverse Event

Iomab-B Arm (N=56)

Conventional Care Arm (N=57)

Received Iomab-B/HCT

(N=49)1

Achieved CR and received Std HCT (N=10)

No CR Crossed over to Iomab-B/HCT (N=30)

Sepsis

% (N)

4.2 (2)*

30.0 (3)

23.3 (7)

Febrile Neutropenia Gr 3-4

% (N)

41.7 (20)

50.0 (5)

40.0 (12)

Mucositis Gr 3-4

% (N)

10.4 (5)

30.0 (3)

16.7 (5)

Day +100 Non-Relapse Mortality3

2/45(4.4%)

Here is the original post:
Actinium Showcases Targeted Conditioning Program with 2 Oral Presentations Highlighting Iomab-B and Pivotal Phase 3 SIERRA Trial at 2021...

VM202, a plasmid DNA that expresses 2 isoforms of hepatocyte growth factor, is both safe and effective in providing long-lasting pain relief in painful diabetic peripheral neuropathy (DPN), according to results of a phase 3-1b study published in Clinical and Translational Science.

Following positive efficacy and safety data results from phase 1 and 2 studies, researchers conducted a large scale, double-blind, placebo-controlled phase 2 study of VM202 for painful DPN. The study was conducted in 2 parts: the main study took place over 9 months (DPN 3-1; ClinicalTrials.gov identifier NCT02427464; N=500 participants), followed by a noninterventional 3-month safety and efficacy extension that included a subset of later-enrolling main study participants (DPN 3-1b; ClinicalTrials.gov identifier NCT04055090; n=101).

Researchers hypothesized that VM202 administration would reduce the average daily diabetic peripheral neuropathy pain scores more than placebo. The primary efficacy endpoint was the mean 24-hour numerical rating scale pain score, recorded in a daily pain and sleep diary at 3 months.

In both studies, most participants were White (74.4% and 80.2%) with an overall mean age of 61.5 years. Many participants had comorbid conditions, including hypertension, dyslipidemia, and obesity.

Between-group demographic and baseline characteristics were similar. At the time of randomization, roughly half of the participants were not receiving either pregabalin or gabapentin to manage DPN.

Researchers assessed safety based on incidence of treatment-emergent adverse events, serious adverse events, and adverse events of special interest (injection site reactions, ophthalmologic or acute cardiac events, foot ulcers, and symptoms of central nervous system depression).

In DPN 3-1, 72.6% of those treated with VM202 and 68.9% of those treated with placebo reported at least 1 treatment-emergent adverse event. The most common adverse events were infections and infestations, which were similar between groups.

Adverse events of special interest occurred in 17.2% and 16.8% of VM202 and placebo patients, respectively. The most common adverse events were diabetic retinopathy, peripheral edema, and skin ulcers. The incidence of these events that were deemed related to the study drug was low, with no difference between groups.

Serious adverse events were reported in 9.6% of the VM202 group and 9.9% of the placebo group. In the VM202 group, adenocarcinoma and vitreous hemorrhage were deemed possibly related to the study drug. Three myocardial infarctions were deemed not related to the study drug due to patients medical history.

In DPN 3-1b, 15.4% and 22.2% of VM202- and placebo-treated patients, respectively, experienced treatment-emergent adverse events. Adverse events of special interest were experienced by 3.1% and 2.8% of VM202- and placebo-treated patients, and included peripheral edema, chest pain, and angina pectoris. One participant in the VM202 group and 2 in the placebo group reported serious adverse events, but all 3 of these participants had relevant medical histories.

DPN 3-1 failed to meet the primary endpoints, with between-group differences that were not statistically significant for any endpoint measure. When the participants who were not receiving concurrent gabapentinoids were analyzed separately (n=251), endpoints remained statistically nonsignificant compared with placebo.

In DPN 3-1b, efficacy data differed strikingly, despite similar participant demographic and baseline characteristics. Although there was no significant pain severity difference at baseline, there were significant reductions in the primary efficacy endpoints at 12 months in the VM202 group compared with placebo. Significant pain reductions were also noted at 6 and 9 months, and greater pain reductions were identified in patients who were not taking gabapentin or pregabalin during the 12-month study, which was consistent with Phase 2 study results.

The researchers stated, To our knowledge, this is the first Phase 3 gene therapy study for pain that has ever been done. VM202 did not meet efficacy endpoints in the fullpopulation, but VM202 demonstrated long-term, clinically significant reductions in pain in [DPN 3-1b], particularly in [participants] not on gabapentinoids

They concluded, Given the excellent safety profile of VM202, the potential for disease modifying effects, and the high unmet medical needs of the DPN patient population not on gabapentinoids, further study is warranted.

Disclosure: This clinical trial was supported by Helixmith Inc. Please see the original reference for a full list of authors disclosures.

Kessler JA, Shaibani A, Sang CN, et al; for the VM202 Study Group. Gene therapy for diabetic peripheral neuropathy: a randomized, placebo-controlled phase 3 study of VM202, a plasmid DNA encoding human hepatocyte growth factor. Published online January 19, 2021. Clin Transl Sci. doi:10.1111/cts.12977

Read the original here:
VM202 Is Safe and Effective for Painful Diabetic Peripheral Neuropathy - Clinical Pain Advisor

Global Ischemic Optic Neuropathy Treatment Market: Overview

Technological progress made in the treatment of ischemic optic neuropathy coupled with the availability of alternative drugs is expected to boost the growth of the global ischemic optic neuropathy treatment market over the period of analysis, from 2020 to 2030. Ischemic optic neuropathies (IONs) are one of the major reasons for seriously impaired vision or blindness usually amongst the elderly and middle-aged people. However, the disease can affect anyone and no human age is immune to it. Increased prevalence of the disease is anticipated to propel expansion of the global ischemic optic neuropathy treatment market in the years to come.

Ischemic optic neuropathies (IONs) come in two types, namely posterior ischemic optic neuropathy (PION) and anterior ischemic optic neuropathy (AION). Inflammation of the arteries that supply blood to the optic nerve causes anterior ischemic optic neuropathy and reasons other than inflammation cause non-anterior ischemic optic neuropathy. However, anterior ischemic optic neuropathy is more commonly found in people than posterior ischemic optic neuropathy. Immediate treatment is needed in case of anterior ischemic optic neuropathy to prevent loss of vision in the affected eye as it also causes damage in the other eye in a span of just 5 to 10 days.

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Hypercholesterolemia, diabetes, and hypertension are some of the causes of the disease. In addition, other medical conditions such as failure of autoregulation, severe anemia, vasospasm, nocturnal hypotension, sleep apnea, and hypoperfusion are likely to cause ischemic optic neuropathies.

Disease type, treatment type, end user, and region are the four important parameters based on which the global ischemic optic neuropathy treatment market has been classified. The thorough evaluation of the market comes with the objective of providing stakeholders with a detailed and clear analysis of the global ischemic optic neuropathy treatment market.

Global Ischemic Optic Neuropathy Treatment Market: Notable Developments

One of the significant developments that give a quick view of the dynamics pertaining to the global ischemic optic neuropathy treatment market is mentioned as below:

In July 2019, Pfizer Inc. acquired US-based pharmaceutical company, Array BioPharma Inc. This acquisition is estimated to strengthen innovative biopharmaceutical business and assist in the meeting the unmet medical needs of diseases like cancer and other rare diseases.

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Some of the prominent organizations in the global Ischemic optic neuropathy treatment market comprise the below-mentioned:

Global Ischemic Optic Neuropathy Treatment Market: Key Trends

The global ischemic optic neuropathy treatment market is characterized by the presence of the following restraints, drivers, and opportunities.

Increased Demand from Various End Use Sectors to Fuel Market Growth

The development of the global ischemic optic neuropathy treatment market is anticipated to register high growth rate over the tenure of assessment. The increased use of intravitreal implants for treating ophthalmology diseases is expected to open new avenues of growth for the global ischemic optic neuropathy treatment market over the forecast period, from 2020 to 2030. Many of the leading drug manufacturing and pharmaceutical companies from the developed countries are making high investment in the research and development activities so to develop better and advanced solutions and reduce the burden of vision and eye-related diseases. Increased spending in infrastructure and new, advanced technologies in ophthalmology therapeutics are likely to account for a larger share of the market in the years to come.

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For patients suffering from ischemic optic neuropathy, corticosteroid is considered as the first choice of therapy, particularly in countries like Russia, France, Germany, and the US. However, several patients have developed resistance to anti-VEGF, which is likely to boost growth of the global ischemic optic neuropathy treatment market over the period of analysis, from 2020 to 2030.

Global Ischemic Optic Neuropathy Treatment Market: Geographical Analysis

North America is estimated to exert dominance over the global ischemic optic neuropathy treatment market and the region is likely to retain its prominence throughout the period of analysis, from 2020 to 2030. Availability of advanced healthcare infrastructure together with increased spending on the research and development activities in the field of ophthalmology is expected to propel growth of the global ischemic optic neuropathy treatment market in the years to come.

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New Jersey, United States,- Verified Market Reports has recently published a market research report titled, Neuropathy Pain Treatment Market Size, Status and Forecast 2021-2027. Analysts have used primary and secondary research methodologies to determine the path of the market. The data includes historic and forecast values for a well-rounded understanding. It is a phenomenal compilation of important studies that explore the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the Neuropathy Pain Treatment market. Players can use the accurate market facts and figures and statistical studies provided in the report to understand the current and future growth of the Neuropathy Pain Treatment market.

This report includes the assessment of various drivers, government policies, technological innovations, upcoming technologies, opportunities, market risks, restraints, market barriers, challenges, trends, competitive landscape, and segments which gives an exact picture of the growth of the Neuropathy Pain Treatment market.

Competitive analysis:

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The report covers the following key players in the Neuropathy Pain Treatment Market:

Pfizer Depomed Eli Lilly Endo Grnenthal Group Arbor Pharmaceuticals

Segmentation of Neuropathy Pain Treatment Market:

The Neuropathy Pain Treatment market report has been segmented into Types, Applications, and End-users. It provides the market share of each segment participating in the Neuropathy Pain Treatment market. Companies operating in this market have a thorough understanding of the fastest-growing segment. That way, they can identify their target customers and allocate their resources wisely. Segment analysis helps create the perfect environment for engagement, customer loyalty, and acquisition. This section will help companies operating in the Neuropathy Pain Treatment market identify key areas of intervention while making their strategic investments.

By the product type, the market is primarily split into:

Calcium Channel Alpha 2-delta Ligands Serotonin-norepinephrine Reuptake Inhibitors

By the application, this report covers the following segments:

Retail Pharmacies Hospitals

Neuropathy Pain Treatment Market Report Scope

Regional analysis:

The Neuropathy Pain Treatment market report covers the analysis of various regions such as North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Market trends change by region and result in changes due to their physical environment. The report, therefore, covers key regions with sales, revenue, market share and growth rate of Neuropathy Pain Treatment in these regions from 2020 to 2027. It analyzes the region with the highest market share as well as the fastest growing region of the Neuropathy Pain Treatment market. The report by region is then broken down into analyzes at the country level. For example, North America is divided into the United States and Canada. Europe includes the UK, France, and Germany, followed by APAC, which includes countries like China, India, and Japan. Latin America is made up of countries like Mexico and Brazil, and the MEA countries included in the Neuropathy Pain Treatment market are the GCC countries and South Africa.

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The research methodology used to aggregate the Neuropathy Pain Treatment market report involves a combination of primary and secondary research approaches. The research team starts desk research from various sources to collect data on the Neuropathy Pain Treatment market. The report combined its data from reliable secondary sources such as company annual reports, industry publications, news, government websites and more. In addition, the primary research includes interviews to get first-hand market intelligence. Our analysts interviewed several C-level executives, decision-makers, board members, key opinion leaders, industry veterans and other stakeholders in the Neuropathy Pain Treatment market. All of the data is then combined and presented in a report to enable a deep understanding and analysis of the Neuropathy Pain Treatment market.

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Neuropathy Pain Treatment Market Size | Latest COVID19 Impact Analysis | Demand, Growth, Trends, Segmentation and Forecasts to 2027 - NeighborWebSJ

Global Neuropathy Pain Treatment Market 2020 by Company, Regions, Type and Application, Forecast to 2025 presents a point of view for the existing market trends, metrics, drivers, and restrictions, and all the important segments. The report specializes in an in-depth study of the global Neuropathy Pain Treatment market with a focus on the global market trend. The report is suitably segmented and sub-segmented so that it can shed light on every aspect of the market such as type of product, application, and region. The research contains key statistics on the market status of the leading market players and offers key trends and opportunities in the market. The report prophesies future revenue, growth, and trend of the market on the basis of recent developments and past data. Then the research emphasizes faster-growing segments and emerging trends in the market.

The report has extracted a systematic analysis of actual and projected market data. Key points covered are Drivers, restraints, opportunities, market revenue, trends shares, vendor profiling, manufacturers or players. The report layouts the global Neuropathy Pain Treatment market segments by defining and evaluating them, and forecast the global market size. The report identifies various developments, broad opportunities, and market growth factors. The study covers current status, market share, future patterns, development rate, SWOT examination, sales channels, to anticipate growth scenarios for the years 2020-2025. It aims to recommend analysis of the market with regards to growth trends, prospects, and players contribution in the market development.

DOWNLOAD FREE SAMPLE REPORT: https://www.marketquest.biz/sample-request/9018

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

Exploring Growth Rate Over A Period:

This report contains data regarding the rise in sales within a given consumer base for the forecast period, 2020 to 2025. With this precisely documented report, business owners can scale up their business. Product owners can use this information along with the driving factors such as demographics and revenue generated from other products discussed in the report to get a better analysis of their products and services. Besides, the research analysts have compared the global Neuropathy Pain Treatment market growth rate with the product sales to assist business owners to determine the success or failure of a specific product or service.

Leading companies covered in this research report: Pfizer, Endo, Depomed, Eli Lilly, Arbor Pharmaceuticals, Grnenthal Group

Market segmentation by product types: Calcium Channel Alpha 2-delta Ligands, Serotonin-norepinephrine Reuptake Inhibitors, Others

Market segmentation by applications: Retail Pharmacies, Hospitals, Others

Key regions and countries covered in this research report: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), MENA (Saudi Arabia, UAE, Turkey and South Africa)

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Moreover, the report will help the industry players in deciding the investment feasibility and development status across the globe. The analysis of global Neuropathy Pain Treatment market share, revenue, pricing analysis, SWOT analysis is covered for all the key market players. All the product segments and sub-segments are studied in detail in this report.

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Global Neuropathy Pain Treatment Market 2020 2025 Business Statistics of Report that Emphasizes the impact of COVID-19 FLA News - FLA News

According to the new market research report Neuropathy Pain Treatment Market Strategic recommendations, Trends, Segmentation, Use Case Analysis, Competitive Intelligence, Global and Regional Forecast (to 2026), published by In4Research, the global Neuropathy Pain Treatment Market size in the post-COVID-19 scenario is projected to grow significantly by 2026.

Study Objectives of Global Neuropathy Pain Treatment Market:

Request for a sample copy of the report to get extensive insights into Neuropathy Pain Treatment market at https://www.in4research.com/sample-request/53942

Research Coverage of Neuropathy Pain Treatment Market:

The market study covers the Neuropathy Pain Treatment market size across different segments. It aims at estimating the market size and the growth potential across different segments, including application, type, organization size, vertical, and region. The study further includes an in-depth competitive analysis of the leading market players, along with their company profiles, key observations related to product and business offerings, recent developments, and market strategies.

Major Key Players Covered in The Neuropathy Pain Treatment Market Report include

Neuropathy Pain Treatment Market Segmentation by Type, Application, and Region as follows:

By Type:

By Application:

Geographically, this report is segmented into several key Regions along with their respective countries, with production, consumption, revenue, and market share and growth rate of Neuropathy Pain Treatment in the following regions:

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Valuable Points Covered in Neuropathy Pain Treatment Research Study are:

Moreover, the analyst who has authored the report has completely estimated the market potential of the key applications and recognized the future opportunities. The top players in the global Neuropathy Pain Treatment market are covered based on their market size, served market, products, applications, and regional growth. The report comprises the industry deliverables such as market size, sales volume, valuation forecast, etc. The report focuses on the upstream raw material analysis, downstream analysis, manufacturing base, and import-export details.

Any Questions/Queries or need help? Speak with our analyst https://www.in4research.com/speak-to-analyst/53942

Key Topics Covered in Neuropathy Pain Treatment Research Study are:

Introduction

Value Chain Analysis

Porters Five Forces Analysis

Pricing Analysis

And more

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Recent Study on Neuropathy Pain Treatment Market 2021 Including Key Players, Applications, and Growth Size By 2026 NeighborWebSJ - NeighborWebSJ

Market Study Report, LLC, has recently added a report on ' Diabetic Neuropathy market' which offers a comprehensive synopsis of revolving market valuation, market size, SWOT analysis, revenue estimation and geographical spectrum of the market. The report further elucidates primary business obstacles and growth prospects within the forecasted timeline, while examining the current competitive sphere involving key players of the ' Diabetic Neuropathy market'.

The research analysis of Diabetic Neuropathy market provides a broad perspective of the major development trends, limitations, and restraints as well as growth opportunities, which are slated to define the industry growth rate in the subsequent years.

Request a sample Report of Diabetic Neuropathy Market at:https://www.marketstudyreport.com/request-a-sample/3171246?utm_source=Algosonline.com&utm_medium=Ram

According to the report, the Diabetic Neuropathy market is predicted to witness a y-o-y growth rate during the analysis timeframe (2021-2026) and generate lucrative returns by the end of the forecast duration.

The advent of COVID-19 pandemic is expected to have some modifications to the growth of this business vertical. Various organizations operating in this industry landscape are compelled to revisit their respective budgets in order to establish a proper profit trajectory for the ensuing years. Thus, the study offers an in-depth analysis regarding the impact of the COVID-19 pandemic on the overall industry remuneration.

Apart from this, the document also highlights the various segmentations and their individual contribution towards the overall market outlook.

Major information from the Diabetic Neuropathy market report:

Ask for Discount on Diabetic Neuropathy Market Report at:https://www.marketstudyreport.com/check-for-discount/3171246?utm_source=Algosonline.com&utm_medium=Ram

Diabetic Neuropathy Market segments covered in the report:

Regional segmentation: North America, Europe, Asia-Pacific, South America, Middle East and Africa

Product types:

Applications spectrum:

Competitive outlook:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-diabetic-neuropathy-market-2021-by-company-regions-type-and-application-forecast-to-2026

Key Highlights Questions?

Table of Content:

Read More Reports On: https://www.marketwatch.com/press-release/monodose-packaging-for-probiotics-and-nutraceutical-market-share-growth-statistics-by-application-production-revenue-forecast-to-2026-2021-02-05

Contact Us:Corporate Sales,Market Study Report LLCPhone:1-302-273-0910Toll Free:1-866-764-2150Email:[emailprotected]

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Diabetic Neuropathy Market Outlook, Strategies, Manufacturers, Countries, Type and Application, Global Forecast To 2026 - AlgosOnline

Pipeline strategies by manufacturers are focused on introducing advanced drugs with minimum side effects to increase market share. For instance, Pfizer sponsored drug Pregabalin, effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma that is in phase 3 clinical trials. Increasing research and development activities to develop medications for indications such as post-herpetic neuralgia are creating significant opportunities for manufactures to flourish in the market.

Reaching the revenues of overUS$ 6 Bnat the end of 2019, the globalneuropathic pain management marketis projected for a healthy CAGR during the forecast period (2019 2029). Increasing prevalence of neuropathic pain disorders and growing awareness about pain medication are boosting the demand for pain management drugs.

Want a sneak peek into the Neuropathic Pain Market? Access the Table of Content of Neuropathic Pain Market report! @https://www.persistencemarketresearch.com/market-research/neuropathic-pain-market/toc

Pipeline strategies by manufacturers are focused on introducing advanced drugs with minimum side effects to increase market share. For instance, Pfizer sponsored drug Pregabalin, effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma that is in phase 3 clinical trials. Increasing research and development activities to develop medications for indications such as post-herpetic neuralgia are creating significant opportunities for manufactures to flourish in the market.

Get going with a sample of Neuropathic Pain Market report!@https://www.persistencemarketresearch.com/samples/4149

Company Profiles

Key Takeaways Neuropathic Pain Management Market Study

Increasing prevalence of diabetic neuropathy and availability of approved neuropathy pain medications have significantly added to the opportunities for market growth, thereby fostering the rate of adoption of neuropathic pain management drugs.

Increasing R&D Spending by Pharmaceuticals Companies Shaping Future

One of the key factors observed to impact the neuropathic pain management market growth is the development of new drugs for treatment of neuropathic and chronic pains. Companies are focusing on clinical trials to develop drugs for efficient treatment of neuropathic pain. For instance, Eli Lilly and Company developed Duloxetine (LY248686) for Diabetic Peripheral Neuropathic Pain (DPNP) that is under phase 4 clinical trial.

At the same time, companies are focused on expanding therapeutic applications of drugs such as opioids and steroids for neuropathic pain management without causing any serious side effects to patients. Currently, more than 100 clinical trials are been carried out for pain management. Among those clinical trials, nearly half of the clinical trials are for various indications of neuropathic pain such as diabetic neuropathy and post-herpetic neuralgia.

What Does the Report Cover?

The neuropathic pain management market, a new study from Persistence Market Research, provides unparalleled insights on evolution of the neuropathic pain management market during 2014 2018 and presents demand projections during 2019 2029 on the basis of drug class (tricyclic anti-depressants, anticonvulsants, SNRIs, capsaicin cream, local anesthesia, opioids, steroids, and others), indication (diabetic neuropathy, trigeminal neuralgia, post-herpetic neuralgia, chemotherapy-induced peripheral neuropathy and others), distribution channel (retail pharmacies, hospital pharmacies, and online pharmacies) across prominent regions (North America, Latin America, Europe, Asia Pacific and MEA).

About UsPersistence Market Research (PMR), as a 3rd-party research organization, does operate through an exclusive amalgamation of market research and data analytics for helping business ride high, irrespective of the turbulence faced on the account of financial/natural crunches.Contact Us:Persistence Market Research (PMR)Address 305 Broadway, 7th Floor, New York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales sales@persistencemarketresearch.com

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North America to Stand in a Better Stead in the Neuropathic Pain Market between 2020 and 2030 - Industry Today

Diabetes is a common condition that affects around five million people in the UK. But a lot of people may not even know that they have diabetes. You could be at risk if you develop a subtle pain in your legs.

Diabetes is a life-long condition, and 90 percent of all cases are caused by type 2 diabetes.

Type 2 diabetes is where the body struggles to produce enough of the hormone insulin.

Insulin helps the body to convert sugar in the blood into useable energy.

But if your body isn't getting enough insulin, the amount of sugar in your blood starts to rise, which can lead to diabetes.

READ MORE: Type 2 diabetes symptoms - 'dark adaption' could be a warning sign

"Diabetic neuropathy is a type of nerve damage that can occur if you have diabetes," said the Mayo Clinic.

"High blood sugar can injure nerves throughout your body. Diabetic neuropathy most often damages nerves in your legs and feet.

"Depending on the affected nerves, diabetic neuropathy symptoms can range from pain and numbness in your legs and feet to problems with your digestive system, urinary tract, blood vessels and heart.

"Some people have mild symptoms. But for others, diabetic neuropathy can be quite painful and disabling."

Meanwhile, other common symptoms of diabetes include passing more urine than normal, and feeling unusually tired.

Some people also find that they're always feeling thirsty, despite drinking plenty of fluids.

Speak to a doctor if you're worried about the signs of diabetes.

Diagnosing the condition early could help to lower your risk of diabetes complications, including strokes or heart disease.

Read more from the original source:
Diabetes symptoms: Sign in your legs of high blood sugar - the 'pain' you shouldn't ignore - Express

DUBLIN, Ireland, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, today reported financial results for the fourth quarter and full year 2020. In addition, the Company provided 2021 financial guidance and an update on its R&D programs.

We continue to see positive momentum in our pipeline with the recent announcement of the confirmatory, registration-enabling Phase 3 AFFIRM-AL study of birtamimab in AL amyloidosis and positive clinical findings reported in 2020 from both the Phase 2 study of prasinezumab in Parkinsons disease and Phase 1 study of PRX004 in ATTR amyloidosis, said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. We are particularly pleased that our unique protein dysregulation platform has now resulted in the translation of our preclinical findings into clinical benefit for patients across multiple programs in our portfolio. We look forward to a number of significant milestones in 2021, with the planned initiation of 3 late-stage clinical studies, including the birtamimab AFFIRM-AL study, the prasinezumab Phase 2b study and the PRX004 Phase 2/3 study. In addition to these late-stage programs, we have also advanced the three targets under our global neuroscience collaboration with Bristol-Myers Squibb and expect to file an IND for PRX005 this year. Our strong cash position and potential partner payments provide a foundational capital position to fund the company through value-creating milestones as we transition to a fully integrated commercial company.

Story continues

Full Year 2020 and Recent Developments:

Birtamimab, a potential treatment for AL amyloidosis, is a humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Based on significant survival benefit observed in the previous VITAL study in Mayo Stage IV patients (HR=0.413, p=0.025, over 9 months) and multiple in-depth discussions with the U.S. Food and Drug Administration (FDA), Prothena announced plans in February 2021 to advance birtamimab into the confirmatory Phase 3 AFFIRM-AL study in Mayo Stage IV patients with AL amyloidosis. AFFIRM-AL is a global, registration-enabling Phase 3 study that will be conducted with a primary endpoint of all-cause mortality at p0.10 under a Special Protocol Assessment (SPA) agreement with FDA.

Prasinezumab, a potential treatment for Parkinsons disease, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

Presented results from Phase 2 PASADENA study showing prasinezumab significantly slows progression on pre-specified clinical measures of Parkinsons disease in September 2020 at the International Parkinson and Movement Disorder Societys 2020 Congress. Prasinezumab is the first potentially disease-modifying, anti-alpha-synuclein antibody to demonstrate signals of efficacy on multiple pre-specified secondary and exploratory clinical endpoints in patients with early Parkinsons disease.

Announced that Roche and Prothena will advance prasinezumab into a late-stage Phase 2b study in patients with early Parkinsons disease. The study will be designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinsons disease on stable levodopa therapy. Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage development.

PRX004, a potential treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein

Reported results from the Phase 1 study of PRX004, the first anti-amyloid immunotherapy designed to deplete amyloid to demonstrate efficacy in ATTR amyloidosis. In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels.

PRX012, a potential treatment for Alzheimers disease, is monoclonal antibody targeting key epitopes within the N-terminus of A

Multi-immunogen vaccine, for the potential prevention and treatment of Alzheimers disease, is a multi-immunogen A-tau vaccine

Presented data on a multi-immunogen vaccine that targets key A and tau epitopes, the two main pathological proteins involved in the cause and progression of Alzheimers disease, at the CTAD Conference in November 2020

Corporate

Appointed Brandon Smith as Chief Business Officer, responsible for leading Prothenas business development activities, portfolio strategic planning and alliance management activities. Mr. Smith joined Prothena after serving as Chief Operating Officer at Iconic Therapeutics

Upcoming Milestones:

Birtamimab

Prasinezumab

New pre-specified exploratory subgroup analyses from Part 1 of the Phase 2 PASADENA study to be presented at the 15th International Conference for Alzheimers and Parkinsons Diseases in March 2021 (ADPD 2021)

$60 million clinical milestone payment to be achieved upon first patient dosed in late-stage Phase 2b study in patients with early Parkinsons disease; further details expected in 2Q 2021

Results from Part 2 of the PASADENA study expected to be presented at an upcoming medical conference

PRX004

PRX005

Preclinical data to be presented in March at ADPD 2021

IND filing expected 3Q 2021

$80 million potential payment from Bristol-Myers Squibb upon exercising their US license option in 2021

PRX012

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

H.C. Wainwright Global Life Sciences Conference on Tuesday and Wednesday, March 9-10, 2021, virtual presentations will be available on demand both days

Oppenheimer 31st Annual Healthcare Conference on Wednesday March 17, 2021 at 10:00 AM ET

Stifels 3rd Annual CNS Day on Thursday April 1, 2021 at 8:00 AM ET

Fourth Quarter and Full Year of 2020 Financial Results and 2021 Financial Guidance

For the fourth quarter and full year of 2020, Prothena reported a net loss of $30.7 million and $111.1 million, respectively, as compared to a net loss of $21.6 million and $77.7 million for the fourth quarter and full year of 2019, respectively. Net loss per share for the fourth quarter and full year of 2020 was $0.77 and $2.78, respectively, as compared to a net loss per share of $0.54 and $1.95 for the fourth quarter and full year of 2019, respectively.

Prothena reported total revenue of $0.4 million and $0.9 million for the fourth quarter and full year of 2020, respectively, primarily due to license revenue in the fourth quarter and collaboration revenue for the full year as compared to total revenue of $0.3 million and $0.8 million for the fourth quarter and full year of 2019, respectively, primarily due to Roche collaboration revenue.

Research and development (R&D) expenses totaled $20.8 million and $74.9 million for the fourth quarter and full year of 2020, respectively, as compared to $15.5 million and $50.8 million for the fourth quarter and full year of 2019, respectively. The increase in R&D expense for the fourth quarter and full year of 2020 compared to the same periods in the prior year was primarily due to higher manufacturing costs primarily related to our PRX005, birtamimab and PRX012 programs and to a lesser extent PRX004, higher collaboration expense with Roche related to the prasinezumab program and higher R&D consulting expense. R&D expenses included non-cash share-based compensation expense of $2.1 million and $8.2 million for the fourth quarter and full year of 2020, respectively, as compared to $2.0 million and $8.1 million for the fourth quarter and full year of 2019, respectively.

General and administrative (G&A) expenses totaled $9.9 million and $38.7 million for the fourth quarter and full year of 2020, respectively, as compared to $8.1 million and $35.7 million for the fourth quarter and full year of 2019, respectively. The increase in G&A expenses for the fourth quarter and full year of 2020 compared to the same periods in the prior year was primarily related to higher costs for our director and officer insurance premiums. G&A expenses included non-cash share-based compensation expense of $3.2 million and $13.8 million for the fourth quarter and full year of 2020, respectively, as compared to $3.3 million and $15.5 million for the fourth quarter and full year of 2019, respectively.

Total non-cash share-based compensation expense was $5.2 million and $22.0 million for the fourth quarter and full year of 2020, respectively, as compared to $5.3 million and $23.6 million for the fourth quarter and full year of 2019, respectively.

As of December 31, 2020, Prothena had $298.1 million in cash, cash equivalents and restricted cash and no debt.

As of February 5, 2021, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company expects the full year 2021 net cash used in operating and investing activities to be $51 to $74 million, which includes an expected $60 million milestone payment from Roche upon first patient dosed in the late-stage Phase 2b study of prasinezumab and expects to end the year with approximately $235 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2021 net cash used in operating and investing activities is primarily driven by an estimated net loss of $79 to $111 million, which includes an estimated $20 million of non-cash share-based compensation expense.

Conference Call Details

Prothena management will discuss these results and its 2021 financial guidance during a live audio conference call today, Thursday, February 11, 2021, at 8:30 AM ET. The conference call will be made available on the Company's website at http://www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company's website for at least 90 days.

To access the call via dial-in, please dial (877) 887-5215 (U.S. and Canada toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 5677514. A replay of the call will be available until February 25, 2021 via dial-in at (855) 859-2056 (U.S. toll free) or (404) 537-3406 (international), Conference ID Number 5677514.

About Prothena

Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothenas pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimers disease, Parkinsons disease and a number of other neurodegenerative diseases. For more information, please visit the Companys website at http://www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; our goal of building a protein dysregulation platform; the treatment potential and proposed mechanisms of action of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and multi-immunogen A-tau vaccine; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; amounts we might receive under our collaborations with Roche and Bristol-Myers Squibb; the expected timing of reporting data from prior clinical studies of birtamimab, the Phase 2 clinical study of prasinezumab, and preclinical studies of PRX005; our anticipated net cash burn from operating and investing activities for 2021 and expected cash balance at the end of 2021; and our estimated net loss and non-cash share-based compensation expense for 2021. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the Risk Factors sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2020, discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC, and our Annual Report on Form 10-K to be filed with the SEC for our fiscal year 2020. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

PROTHENA CORPORATION PLCCONSOLIDATED STATEMENTS OF OPERATIONS(unaudited - amounts in thousands except per share data)

Three Months EndedDecember 31,

Twelve Months EndedDecember 31,

2020

2019

2020

2019

Collaboration revenue

$

121

$

256

$

564

$

814

License revenue

239

289

Total revenue

360

256

853

814

Operating expenses:

Research and development

20,760

15,471

74,884

50,836

General and administrative

9,908

8,059

38,703

35,736

Restructuring (credits)

(61

)

Total operating expenses

30,668

23,530

113,587

86,511

Loss from operations

(30,308

)

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Prothena Reports Fourth Quarter and Full Year 2020 Financial Results, and Provides Financial Guidance and R&D Update - Yahoo Finance

Diabetic Foot Ulcer Therapeutics Market is valued at USD 2549.3 Million in 2018 and expected to reach USD 4397.4 Million by 2025 with a CAGR of 8.1% over the forecast period. Increasing geriatric population across the globe is anticipated to drive growth of Global Diabetic Foot Ulcer Therapeutics Market.

Diabetic foot ulcers are a common complication of poorly controlled diabetes, forming as a result of skin tissue breaking down and exposing the layers underneathThere is a more possibility that people with diabetes can develop foot ulcers but good foot care can help prevent them. Theyre most common under the big toes and the balls of feet, and they can affect the feet down to the bones. The risk of developing a diabetic foot ulcer increases with in time. The major causes of diabetic ulcers includes; poor circulation, high blood sugar, nerve damage and irritated or wounded feet. A majority of non-infected foot ulcers are treated without surgery; however, if this treatment fails, surgical management may be appropriate. Major surgical procedures to remove the pressure on affected area majorly include the correction of various deformities such as hammertoes, bunions, or bony bumps and shaving or excision of bone. Healing time depends on a variety of factors which includes; wound size and location, pressure on the wound from walking or standing, blood glucose levels, swelling, circulation, wound care and others. Healing may require few weeks or several months. The top priority in treating the diabetic foot syndrome is to avoid a major amputation.

Get Sample Copy of The Report@https://brandessenceresearch.com/requestSample/PostId/308

Global diabetic foot ulcer therapeutics market report is segmented on the basis of product type, ulcer type, end-user and region & country level. Based upon product type, global diabetic foot ulcer therapeutics market is classified into wound care dressings, therapy devices, biologics, antibiotic medications and others. Based upon ulcer type, global diabetic foot ulcer therapeutics market is divided into neuropathic ulcers, neuro-ischemic ulcers and ischemic ulcers. Based on end-user, the diabetic foot ulcer therapeutics market is classified into hospitals, ambulatory surgical center, specialty clinics and others.

The regions covered in this Global Diabetic Foot Ulcer Therapeutics Market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, the market of diabetic foot ulcer therapeutics is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, Middle East Asia (UAE, Saudi Arabia, Egypt) GCC, Africa, etc.

Some major key players for global diabetic foot ulcer therapeutics market are Acelity L.P. Inc., 3M Healthcare, ConvaTec, Inc., Medline Industries, Inc., Medtronic Plc., Coloplast A/S, Smith & Nephew Plc., B. Braun Melsungen AG, Molnlycke Health Care AB, Organogenesis, Inc., BSN Medical GMBH and others.

Increasing Geriatric Population Coupled with the Increasing Prevalence of Diabetes Worldwide Drives Global Diabetic Foot Ulcer Therapeutics Market

The major factor driving the growth of global diabetic foot ulcer therapeutics market is increasing incidences of foot ulcers coupled with the increasing prevalence of diabetes. For example; As per National Center for Biotechnology Information; The prevalence of diabetic foot ulcer among diabetic patients in Gondar University Referral Hospital was found to be high. Residence, higher BMI (overweight and obesity), types of diabetes, neuropathy, and foot self-care practice were factors significantly associated with diabetic foot ulcer. In addition, increasing inclination towards the avoidance of surgeries and amputation is also supplementing the growth of diabetic foot ulcer market. Furthermore, increasing geriatric population is also fostering the market growth as this population is more prone to diabetes. However, high cost of ulcer treatments may hamper the market growth. In spite of that, increasing advancements in and adoption of innovative ways of treatments can provide various opportunities for the further growth of the market.

North America is Expected to Dominate the Global Diabetic Foot Ulcer Therapeutics Market

The global diabetic foot ulcer therapeutics market is segmented into North America, Europe, Asia-Pacific Latin America and Middle East & Africa. North America is expected to dominate the global diabetic foot ulcer therapeutics market within the forecast period attributed to large diabetic patient pool due to the an aging population and the growth of minority populations are expected to add to the diseases prevalence. For example; Centers for Disease Control and Prevention; In the United States, Currently, 1 in 10 Americans has Type 2 diabetes and if current trends continue then 1 in 3 people will have Type 2 diabetes by 2050. But if new cases develop as estimated then its prevalence could double or triple over the next 40 years. In addition, highly developed healthcare infrastructure and increasing adoption of wound care devices are also supplementing the growth of diabetic foot ulcer therapeutics market in this region.

Asia Pacific is anticipated to witness a lucrative growth in global diabetic foot ulcer therapeutics market owing to the increasing geriatric population which is more prone to diabetes. The aging of the population in China and India will bring with it an increase in the burden of chronic disease. The number of people with diabetes in China is projected to increase 103.4 percent, from 20.8 million to 42.3 million, between 2000 and 2030. In comparison, the rate of diabetes in India is expected to increase 150.5 percent, from 31.7 million to 79.4 million, over the same period.

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Key Benefits Market Report

Market Segmentation:-

By Product Type:

By Ulcer Type:

By End-User:

By Regional & Country Level:

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Pain is a common cancer symptom. In fact, its estimated that approximately 66 percent of people with cancer will experience pain as a symptom at some point.

Cancer pain can have several causes. These can include the cancer itself or the effects of various treatments or surgeries that are used to treat the cancer.

While all cancers can cause pain, some, such as those affecting the bones or pancreas, are more frequently associated with pain. Regardless of the type of cancer, its important that remember that cancer pain can often be treated.

Continue reading below to learn more about cancer and pain, how this pain can be managed, and more.

All cancers have the potential to cause pain. The amount of cancer pain you may experience can depend on many different factors, including:

According to the National Cancer Institute, younger individuals are more likely to experience cancer pain and people with advanced cancer tend to experience more severe pain.

When the cancer itself causes pain, its often due to a tumor thats pressing on other organs, bones, or nerves. Tumors can also spread to other areas, such as the spinal cord and bones, leading to pain as well.

Below, well discuss some types of cancer that are commonly associated with pain and why the pain may occur. As we do so, its important to keep in mind that even severe cancer pain can be treated.

Bone cancer is when cancer occurs in your bones. Cancer that originates in the bone, which is called primary bone cancer, is actually quite rare in adults. In fact, it makes up only 0.2 percent of all cancers.

Many times, when someone has bone cancer, its actually due to cancer thats spread to the bones from another location in the body. This can happen with many types of cancer, such as those of the breast, lung, and prostate.

Pain is one of the main symptoms of cancer in the bones. The presence of cancer cells can interfere with the normal maintenance of bone tissue, making your bones weaker. A growing tumor may also press on nerves around the bone.

The pain from bone cancer often begins as a dull pain that comes and goes and is typically worse at night. Eventually, the pain can become constant. Because bone tissue has become weak, its also prone to breaking.

Pancreatic cancer is cancer that develops in your pancreas. The pancreas is an organ that produces enzymes that are important for digestion. It also helps to regulate your blood sugar.

In its early stages, pancreatic cancer can be asymptomatic. Because of this, about 80 percent of pancreatic tumors are detected at more advanced stages. When symptoms are present, they can include abdominal or back pain, jaundice, and weight loss.

Pain from pancreatic cancer can be severe. It can be due to a tumor that presses on surrounding nerves, the spine, or organs in your abdomen like your liver or intestines.

Head and neck cancers are those that start in your:

The symptoms of head and neck cancer can depend on their specific location but often include pain. Like other types of cancer, pain is often due to a tumor that presses on surrounding nerves and structures.

Cancer pain can be exacerbated in the head and neck because the area has a high number of nerves. Additionally, your head and neck contain many structures that are situated within a relatively small space.

A tumor in your head or neck can also cause discomfort by interfering with various body functions. These can include things like eating, swallowing, or breathing.

Your brain and spinal cord make up your central nervous system (CNS). The CNS collects, processes, and responds to sensory information collected from your body and your environment. Think of it as your bodys control center.

Tumors around your brain or spinal cord can put pressure on the surrounding nerves and structures, leading to pain. This can also cause other symptoms like seizures, trouble with movement, and sensory problems.

The most common symptom of a brain tumor in adults is headache. These headaches often become more frequent and severe as time passes.

Pain from a tumor affecting the spinal cord can be characterized as burning, sharp, or tingling. It can happen at a specific location and may also radiate out to other areas of the body. It can be severe and may become constant as time passes.

Lung cancer is cancer that starts in your lungs. Its one of the most common cancers in the world.

Similar to pancreatic cancer, lung cancer has few symptoms in its early stages. Because of this, many times it isnt diagnosed until more advanced stages.

As lung cancer grows and spreads, it can put pressure on your lungs and chest wall. This can lead to chest pain that gets worse when you breathe, cough, or laugh.

Additionally, tumors may partially or completely block some airways. This can also lead to discomfort and can cause distressing symptoms like shortness of breath and wheezing.

There are many different ways to help manage cancer pain. Lets take a deeper dive into some of them below.

Many times, medications are prescribed to help ease cancer pain. Your doctor will select a medication based on whether your pain levels are mild, moderate, or severe.

Some examples of medications that can be given for cancer pain are:

In addition to medications, there are other ways to help manage cancer pain. These can include:

In addition to pain thats caused from the cancer itself, the various types of cancer treatments can also potentially lead to pain. Lets explore this further.

Surgery may be used to remove a tumor from your body. If you have surgery for cancer, its normal to experience postoperative pain in the days or weeks after your procedure.

Pain from surgery is typically treated using medications. Its possible youll need to use stronger pain medications right after your surgery and then switch to less strong medications in the following days.

In some cases, you may experience phantom pain following surgery. This is pain or discomfort that feels like its coming from an area of your body thats been removed. It may happen if youve had a breast or limb surgically removed.

There are several treatment methods that may work for phantom pain. These include medications, TENS, or physical therapy.

Chemotherapy uses strong medications to kill cancer cells. However, it can also lead to side effects that can be painful. One of these is chemotherapy-induced peripheral neuropathy (CIPN), which can cause pain, numbness, and tingling.

According to the National Cancer Institute, studies on medications and natural products to help relieve pain due to CIPN have had mixed results. Some examples of medications that may be used include:

Alterative treatment methods for CIPN are also being explored. Some examples of these include acupuncture and relaxation therapy.

Mouth and throat sores may also develop as a side effect of chemotherapy. While these often go away on their own eventually, you can ease discomfort by applying a topical pain medication and avoiding foods that may irritate the sores.

Radiation therapy utilizes high amounts of radiation to kill cancer cells. Like chemotherapy, it may also cause painful side effects. These can include:

Treatment for the side effects of radiation therapy can depend on the symptoms youre experiencing. They may include pain medications, steroids for inflammation, or antiseizure medications for nerve pain.

Other types of cancer treatments, such as immunotherapy and targeted therapy may cause pain as a side effect as well.

Medications are used to help ease these side effects as you receive treatment. Side effects typically go away once your treatment ends.

Cancer pain can be effectively managed using a variety of methods, helping to ease this symptom and improve your quality of life. Because of this, talk with your doctor if you have cancer and experience pain that:

When you see your doctor, be sure to tell them:

Its likely that youll be asked to rate your pain on a scale. For example, this may be done on scale of 1 to 10, where 1 would mean that youre experiencing little pain and 10 would mean that youre experiencing very severe pain.

Your doctor and care team can use this information as well as your medical history to help develop a plan to better manage your pain.

If youve recently been diagnosed with cancer, you may feel scared or worried. There are resources that can help you to cope with these feelings.

One of these resources is support groups. Support groups are made up of people whose lives have been touched by cancer. These can include other people with cancer, their loved ones, and cancer survivors.

In these groups, you can discuss your experience with cancer, learn about new treatments, and receive support and encouragement from others. Some resources for finding a support group near you are:

Its also possible that you may not be ready to talk about your feelings in a group setting. This is completely normal.

If youre feeling distressed, anxious, or depressed about your diagnosis, it may be beneficial to speak to a mental health professional like a psychologist or psychiatrist. Your doctor can recommend one near you that has experience working with people with cancer.

Pain is a common symptom of cancer. It can be caused by the cancer itself, by the methods used to treat cancer, or both.

Some cancers are associated with more pain than others. These can include those of the bones, pancreas, and head and neck. However, pain can happen with all cancers.

Its always important to keep in mind that cancer pain is treatable. In fact, there are many methods that may be used to manage cancer pain.

Speak to your doctor if you have new pain, pain that doesnt go away, or pain that happens even when you take your current pain medications. They can work with you to adjust your pain management plan to help alleviate cancer pain.

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