VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") today announced that its investigational LEAPS rheumatoid arthritis vaccine candidate has been accepted for a new program of technology commercialization and niche analysis managed by Foresight Science & Technology for the U.S. National Institutes of Health (NIH). CEL-SCI’s selection into this commercialization program, including market entry strategy and launch tactics, is an extension of the Phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 awarded to CEL-SCI in July 2014 from the NIH’s National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS).
Only a select number of SBIR recipients are additionally awarded the commercialization and launch niche analysis program, which will examine the market in depth for the LEAPS rheumatoid arthritis vaccine. This analysis will include interviews with experts and end-users, recommendations for a market entry, launch tactics and revenue projections. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.
“As we advance the clinical development program for our LEAPS rheumatoid arthritis vaccine, we are very pleased that the NIH has recognized the potential market value of this product. We believe the commercialization and program niche analysis will be of value to CEL-SCI as we apply for a Phase II SBIR grant to continue to support our efforts of bringing LEAPS into human clinical trials,” stated Daniel Zimmerman, Ph.D., Senior Vice President Research and Development, Cellular Immunology.
L.E.A.P.S. (Ligand Epitope Antigen Presentation System) is a CEL-SCI patented platform technology designed to stimulate antigen-specific immune responses in T-cells using synthetic peptides. LEAPS constructs physically link the antigenic peptide with a T-cell binding ligand and are delivered directly to the recipient immune system by injection or mucosal absorption, potentially enhancing T-cell responses to a particular antigen.
In pre-clinical work conducted by Tibor Glant, MD, Ph.D. and his team at Rush University Medical Center in Chicago in collaboration with CEL-SCI, data showed that the administration of a proprietary peptide using CEL-SCI's LEAPS technology prevented the development, and lessened the severity, including inflammation, of experimental rheumatoid arthritis when it was administered after the disease was induced in animals. This data was presented in May 2013 by Dr. Zimmerman, at the symposium on "Therapeutic Approaches to Autoimmunity" during the American Association of Immunologists (AAI) 100th annual meeting.
About Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% of the global population and is associated with significant morbidity and increased mortality. Anti-TNF related therapies are the current standard treatment of patients with advanced RA, but over half of the RA patients do not respond to current anti-TNF drugs such as etanercept (Enbrel®) and infliximab (Remicade®).
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current SOC as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase 1 trial in conjunction with the U.S. Naval Medical Center, San Diego, under a CRADA and at the University of California, San Francisco (UCSF).
CEL-SCI is also developing its pre-clinical LEAPS technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis.
The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
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. 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 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-SCI Corporation's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2014. 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 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 have 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 (Leukocyte Interleukin, Injection). 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 currently in progress.