CEL-SCI Awarded Patent for LEAPS Vaccine in Treatment of Rheumatoid Arthritis
January 08 2018 - 7:50AM
Business Wire
LEAPS Platform Technology is currently being
developed as a therapeutic vaccine for rheumatoid arthritis with
support of a NIAMS grant of the NIH
CEL-SCI Corporation (NYSE American: CVM) today announced
that the European Patent Office has issued CEL-SCI patent EP
2254588B1 titled, “Method of Preparation and Composition of Peptide
Constructs for Treatment of Rheumatoid Arthritis” for the Company’s
LEAPS™(*) platform technology. CEL-SCI’s 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 LEAPS platform technology is currently being developed as a
potential therapeutic vaccine for rheumatoid arthritis under a $1.5
million grant from National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) of the U.S. National
Insitututes of Health (NIH). Upon completion of preclinical
investigational new drug (IND) enabling studies for the LEAPS-based
rheumatoid arthritis vaccine candidate, CEL-SCI intends to file an
IND application with the U.S. Food and Drug Administration to allow
the rheumatoid arthritis vaccine to be tested in humans to
determine its safety and potential therapeutic usefulness.
“As we move the first LEAPS platform vaccine candidate towards
potential human studies, we are pleased to have this important
patent issued in Europe. This patent, and other patent applications
currently being pursued around the world, expand and fortify our
intellectual property coverage for our LEAPS technology platform,”
said Dr. Daniel Zimmerman, Senior Vice President of Research,
Cellular Immunology.
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.
In animal challenge tests conducted in collaboration with the
NIH, the US Navy, and several highly regarded universities, LEAPS
platform technology has been shown to direct the immune response
preferentially to a cellular (e.g. T-cell), humoral (antibody) or
mixed pathway. It 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 is a Phase 3 cancer immunotherapy company. When it comes
to cancer immunotherapy, CEL-SCI believes it is most logical to
boost the patient’s immune system while it is still intact in order
to have the greatest possible impact on survival. Therefore,
CEL-SCI treats patients who are newly diagnosed with head and neck
cancer with its lead investigational immunotherapy Multikine**
(Leukocyte Interleukin, Injection), BEFORE they have received
surgery, radiation and/or chemotherapy. This approach is unique.
Most other cancer immunotherapies are used only after conventional
therapies have been tried and/or failed. Head and neck cancer
represents about 6% of all cancers. Multikine has received Orphan
Drug designation from the FDA for the treatment of head and neck
cancer patients with advanced squamous cell carcinoma.
The Company’s LEAPS technology is being developed as a potential
therapeutic vaccine for rheumatoid arthritis and is supported by a
grant from the National Institute of Arthritis and Musculoskeletal
and Skin Diseases of the National Institutes of Health. 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’s filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K for the year
ended September 30, 2017. 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.
* LEAPS is the trademark that CEL-SCI has registered for this
investigational technology, currently in preclinical development.
LEAPS has not been licensed or approved for sale, barter or
exchange anywhere in the world.
** 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.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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