VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that the European Patent Office has issued CEL-SCI patent: European Patent 2989121 to be published on October 7, 2020, and titled Method of Preparation and Composition of Peptide Constructs for Treatment of Rheumatoid Arthritis for the Companys LEAPS platform technology. CEL-SCIs LEAPS technology relates to peptide constructs which may be useful in the treatment or prevention of autoimmune diseases, particularly rheumatoid arthritis, asthma, allergies, and host versus graft (or graft versus host) rejection.
The basic goal of this technology is to 'modulate' the immune system of a patient with Rheumatoid Arthritis, and other autoimmune diseases, away from the body attacking itself to a more normal immune response where the body does not attack itself. This should result in a decrease or elimination of the symptoms of the disease. We are in the process of completing pre-IND studies for CEL-4000, being developed against Rheumatoid Arthritis, and hope to start human studies with CEL-4000 next year. LEAPS is also currently being tested at the University of Georgia vaccine center against COVID-19, said Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology.
The LEAPS platform technology is being developed as a potential therapeutic vaccine for rheumatoid arthritis under phase I and phase II SBIR grants of over $1.7 million from National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the U.S. National Institutes of Health (NIH) which was used in part to fund IND enabling studies in non-human primates.
In animal challenge tests conducted in arthritic diseased animals using CEL-4000 as a therapeutic treatment in collaboration with our Rush Universities Medical center collaborators and co-inventors on this patent, LEAPS platform technology has been shown to direct the immune response preferentially to a cellular (e.g. T-cell) response, reducing pro inflammatory cytokines (IFN and IL17A) and enhancing production of anti-inflammatory cytokines (IL4 and IL10). Additional studies in other disease models have shown either cellular, humoral (antibody) or mixed pathway immune responses depending on the disease model and the desired type of protection.
LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen. Usually given after the disease process is initiated and underway. That is not being used as a preventative agent or conventional preventative vaccine.
The LEAPS conjugates can potentially be utilized to treat diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., rheumatoid arthritis), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's).
About CEL-SCI Corporation
CEL-SCI believes that boosting a patients immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the studys protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen first - for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system see the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the bodys immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the database lock and analysis phase.
The Companys LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk patients. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCIs filings with the Securities and Exchange Commission, including but not limited to its amended report on Form 10-K/A for the year ended September 30, 2019. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
Read the original post:
CEL-SCI Awarded European Patent for LEAPS Vaccine in Treatment of Rheumatoid Arthritis - Business Wire
- Team USA diver from The Woodlands fights juvenile arthritis - FOX 26 Houston - May 5th, 2024
- The best products for arthritis in hands 2024 - National Geographic - May 5th, 2024
- Analysis Strongly Supports Turmeric Supplementation to Improve Arthritis and Osteopenia - Good News Network - May 5th, 2024
- May is arthritis awareness month - SSM Health - May 5th, 2024
- Lower CVD Risk With Stable DMARD Therapy in Seropositive RA - Medscape - May 5th, 2024
- Arthritis Pain: Which Vitamins and Minerals Are Best? - Shape Magazine - May 5th, 2024
- Psoriatic Arthritis Triggers: Stress, Illness, Weather and More - Health Central - May 5th, 2024
- Arthritis Foundation Partners with Target to Produce Ease of Use Design Guides for Product and Packaging Design - AccessWire - May 5th, 2024
- MSPCA seeks donations to help offset cost of surgery for German shepherd with severe arthritis - Boston News ... - Boston News, Weather, Sports | WHDH... - May 5th, 2024
- Team USA diver from The Woodlands fights juvenile arthritis - FOX 5 Atlanta - May 5th, 2024
- May 18: It's time to Walk to Cure Arthritis - Manchester Ink Link - May 5th, 2024
- Cracking Knuckles Causes Arthritis And Other Common Myths Debunked - Onlymyhealth - May 5th, 2024
- Fast Five Quiz: The Role of Joint Replacement Surgery in PsA - Page 2 - Medscape Reference - May 5th, 2024
- Arthritic Therapeutic Market Poised to Surpass $136.1+ Billion Globally by 2032, Fueled by a 5.5% CA - PharmiWeb.com - May 5th, 2024
- Pharmacist explains best diet to reduce arthritis, inflammation and joint pain - The Mirror - March 10th, 2024
- Teen Raises Funds to Fight Arthritis - Arthritis Foundation - March 10th, 2024
- Is there a higher risk of depression among specific populations of patients with rheumatoid arthritis? - News-Medical.Net - March 10th, 2024
- Here's How to Explain Your Arthritis Pain to Your Doctor So They Actually Get It - Northwest Georgia News - March 10th, 2024
- Despite Their Prevalence, Arthritis, Neck and Back Pain Receive Few Research Dollars, Analysis Finds | BIDMC of ... - Beth Israel Deaconess Medical... - March 10th, 2024
- This Is the Difference Between Rheumatoid and Psoriatic Arthritis - Prescott Daily Courier - March 10th, 2024
- The #1 Early Sign of Arthritis Most People Miss, According to a Rheumatologist - Northwest Georgia News - March 10th, 2024
- The Efficacy and Safety of Apremilast in the Management of Psoriatic Arthritis: A Systematic Review and Meta-Analysis - Cureus - March 10th, 2024
- MU Researchers Participating in International Clinical Study Targeting Prevention of Osteoarthritis - University of Missouri School of Medicine - March 10th, 2024
- Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5 - The Center for Biosimilars - March 10th, 2024
- A Gender-Bias-Mitigated, Data-Driven Precision Medicine System to Assist in the Selection of Biological Treatments of ... - Cureus - March 10th, 2024
- Young arthritis cases are on the rise, new research suggests - The Examiner - March 10th, 2024
- Quiz: ACR Guideline for the Treatment of Psoriatic Arthritis - MD Magazine - February 10th, 2024
- Psoriatic arthritis: What to know about medications for children - Medical News Today - February 10th, 2024
- Ancient Egyptian woman had holes on her bones. Experts say its rare case of disease - Miami Herald - February 10th, 2024
- Arthritis and Pregnancy: Fertility, Gestation, Postpartum - Verywell Health - February 10th, 2024
- 3500-year-old burial of Nubian woman reveals 1 of world's earliest known cases of rheumatoid arthritis - Livescience.com - February 10th, 2024
- Impact of frailty severity and severe pain on cognitive function for community-dwelling older adults with arthritis: a cross ... - Nature.com - February 10th, 2024
- IHL-675A: Advancing Towards Innovative Arthritis Solutions, with Mark Bleackley, PhD - MD Magazine - February 10th, 2024
- Insomnia, Shorter Sleep Duration Linked to the Risk of Autoimmune Arthritis - MD Magazine - February 10th, 2024
- Advancements in Psoriatic Arthritis Treatment for Children: A Beacon of Hope - Medriva - February 10th, 2024
- Breakthrough Molecule RvT4 Reverses Inflammation and Clears Arterial Blockages in Rheumatoid Arthritis Patients - SciTechDaily - February 10th, 2024
- Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva - February 10th, 2024
- EULAR Recommendations on Imaging in Crystal-Induced Arthropathies (CiA) - Medriva - February 10th, 2024
- The Importance of Ultrasound-Guided Synovial Biopsy in the Workup of Seronegative Inflammatory Arthritis: A Case ... - Cureus - February 10th, 2024
- Autoimmune diseases like lupus, MS, and rheumatoid arthritis strike far more women than men. Scientists now think they know why - Fortune - February 2nd, 2024
- Multiple Ulcers in the Ileum and Lymphadenopathy Following the Usage of Methotrexate in a Patient With Rheumatoid ... - Cureus - February 2nd, 2024
- These are the best arthritis creams of 2024, according to health experts - Yahoo Life - February 2nd, 2024
- Do Your Joints Ache When a Storm Is Brewing? Here's What's Really Happening - DISCOVER Magazine - February 2nd, 2024
- Olympic bronze medalist opens up about balancing arthritis with motherhood and triathlon - TRI247 - February 2nd, 2024
- Some Dinosaurs May Have Had Arthritis 90 Million Years Ago - IFLScience - February 2nd, 2024
- 3500-year-old remains of ancient Egyptian suffering from rheumatoid arthritis uncovered - Xinhua - February 2nd, 2024
- Lupus and other autoimmune diseases strike far more women than men. Now there's a clue why - The Associated Press - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day on February 2: What you need to know - CNBCTV18 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day 2024: Signs, Symptoms, Diagnosis, and Prevention - News18 - February 2nd, 2024
- Improving arthritis in cold weather | Health Smart - WPMT FOX 43 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day: History, Significance And All You Need To Know - ABP Live - February 2nd, 2024
- Dietary Factors Tied to Osteoarthritis Pain | MedPage Today - Medpage Today - February 2nd, 2024
- Cold-weather coping tips for people with arthritis, osteoporosis and lung diseases - Southernminn.com - February 2nd, 2024
- How to manage arthritis and joint pain: Effective tips for knee pain relief - Health shots - February 2nd, 2024
- New study illuminates the genetics of thumb arthritis treatment - News-Medical.Net - January 25th, 2024
- Rheumatoid arthritis: 30 minutes of walking may lower blood pressure - Medical News Today - January 25th, 2024
- RA Disease Activity Assessed Too Little After Starting TNFi - Medscape - January 25th, 2024
- Lifestyle tips for youth's bone health: Avoid these habits to prevent arthritis - Hindustan Times - January 25th, 2024
- Best arthritis pain relief cream of 2024, according to experts - AOL - January 25th, 2024
- Vasculitis, an Early Unusual Presentation of Rheumatoid Arthritis: A Case Report - Cureus - January 25th, 2024
- Patients with later menarche, earlier menopause have higher risk for rheumatoid arthritis - Healio - January 25th, 2024
- Investigating Maternal Inflammatory Arthritis and Pregnancy Outcomes < Yale School of Medicine - Yale School of Medicine - January 25th, 2024
- Rheumatoid Arthritis and Diabetes: What's the Connection? - Health Central - January 25th, 2024
- Oxidative DNA Damage and Zinc Status in Patients With Rheumatoid Arthritis in Duhok, Iraq - Cureus - January 25th, 2024
- Changes Afoot for the Treatment of Psoriatic Arthritis with Marked Gains in Preference and Utilization of IL-17 Inhibitors - Yahoo Finance - January 25th, 2024
- The Connection Between Potassium and Rheumatoid Arthritis - Health Central - January 25th, 2024
- What Is the ACR20 (American College of Rheumatology) Criteria? - Health Central - January 25th, 2024
- RA Treatment Advances and Where They Are Headed - Health Central - January 25th, 2024
- TMC Medical Minutes- Arthritis & Cold Weather - KXII - January 25th, 2024
- How to deal with joint and arthritis pain in the cold weather - Crossroads Today - January 25th, 2024
- Arthritis: Regular exercises, calcium-rich diet and other habits to keep your bones strong and healthy - Moneycontrol - January 25th, 2024
- Men With Arthritis Have Higher Fertility Rates, Study Finds - Zenger.News - January 25th, 2024
- Pain on Top of Foot: 5 Causes, Swelling, Treatment - Verywell Health - January 25th, 2024
- Understanding Rheumatoid Arthritis in Women: Genetics, Hormones, and Impact - Medriva - January 25th, 2024
- Arthritis | Johns Hopkins Medicine - January 9th, 2024
- Ideal cardiovascular health metrics have better identification of arthritis - BMC Public Health - BMC Public Health - January 9th, 2024
- Acupuncture for Arthritis: Benefits and Risks - Verywell Health - January 9th, 2024
- Why do arthritic horses have more trouble during the winter? - EQUUS Magazine - January 9th, 2024
- Rather than roll over and die, I'm like, 'No, I still want to play': Steve Morse says arthritis diagnosis forced him to ... - Guitar.com - January 9th, 2024
- Top Signs that Your RA Treatment May No Longer Be Working - Health Central - January 9th, 2024