CEL-SCI’s Rheumatoid Arthritis Vaccine Selected for Commercialization & Program Niche Analysis Plan by U.S. National Instit...
November 04 2015 - 10:00AM
Business Wire
NIH previously granted $225,000 to CEL-SCI
for its LEAPS technology which has shown to prevent the development
and lessen the severity of rheumatoid arthritis in preclinical
studies
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.
About LEAPS
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.
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. 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.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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