CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the
"Company") and its Clinical Research Organization (CRO) Ergomed plc
(AIM:ERGO) today announced that they have expanded their
co-development agreement with increased activities to be undertaken
by Ergomed. Pursuant to the expanded co-development agreement,
Ergomed’s contribution to the Phase 3 study will increase from
$10,000,000 to $12,000,000. The companies are undertaking the Phase
3 trial of CEL-SCI’s investigational immunotherapy Multikine*
(Leukocyte Interleukin, Injection) in patients with advanced
primary head and neck cancer.
Under the extended agreement, Ergomed will contribute up to
$12,000,000 towards the cost of performing clinical services for
the Phase 3 study in exchange for a single digit percentage of
milestone and royalty payments, up to a specified maximum amount.
Well over 500 patients have been enrolled in the world’s largest
Phase 3 trial for head and neck cancer.
Ergomed CEO Miroslav Reljanovic stated, “At this point in the
clinical trial we have decided to increase our investment in the
development of Multikine, as we believe that it holds the potential
to treat head and neck cancer in a new way. Our potential returns
from this agreement will increase in line with our investment.”
CEL-SCI CEO Geert Kersten added, “Working with a skilled CRO,
our Phase 3 trial is making significant progress towards completing
study enrollment goals. We are pleased to enter into this expanded
co-development agreement with Ergomed. It further aligns Ergomed’s
goals with CEL-SCI’s as Ergomed will be rewarded for its
$12,000,000 co-development investment from the commercialization of
the drug.”
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced
primary squamous cell carcinoma of the head and neck. The objective
of the study is to demonstrate a statistically significant
improvement in the overall survival of enrolled patients who are
treated with the Multikine treatment regimen plus standard of care
("SOC") vs. subjects who are treated with SOC only.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an
investigational immunotherapeutic agent that is being tested in an
open-label, randomized, controlled, global pivotal Phase 3 clinical
trial as a potential first-line treatment for advanced primary
squamous cell carcinoma of the head and neck. Multikine is designed
to be a different type of therapy in the fight against cancer: one
that appears to have the potential to work with the body's natural
immune system in the fight against tumors.
Multikine is also being tested in a Phase 1 study under a
Cooperative Research and Development Agreement ("CRADA") with the
U.S. Naval Medical Center, San Diego, and at the University of
California, San Francisco (UCSF), as a potential treatment for
peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel
Palefsky, a world renowned scientist and Key Opinion Leader (KOL)
in human papilloma virus (HPV) research and the prevention of anal
cancer, is the Principal Investigator at UCSF, which was added to
the study in July 2015.
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 UCSF.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) 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.
About Ergomed
Founded in 1997, Ergomed plc is a profitable UK-based company,
providing drug development services to the pharmaceutical industry
and has a growing portfolio of co-development partnerships. It
operates in over 40 countries.
Ergomed provides clinical development, trial management and
pharmacovigilance services to over 60 clients ranging from top 10
pharmaceutical and generics companies to small and mid-sized drug
development companies. Ergomed successfully manages clinical
development from Phase I through to late phase programmes.
Ergomed has wide therapeutic expertise, with a particular focus
in oncology, neurology and immunology and the development of orphan
drugs. Ergomed's approach to clinical trials is differentiated from
that of other providers by its innovative Study Site Management
model and the use of Study Physician Teams, resulting in a close
relationship between Ergomed and the physicians involved in
clinical trials.
As well as providing high quality clinical development services,
Ergomed is building a portfolio of co-development partnerships with
pharma and biotech companies. Here Ergomed shares the risks and
rewards of drug development, leveraging its expertise and services
in return for carried interest in the drugs under development. - a
low risk investment model for potential high returns. For further
information, visit: http://ergomedplc.com.
Global pharmacovigilance and medical information services are
provided through its group company PrimeVigilance.
www.primevigilance.com
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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version on businesswire.com: http://www.businesswire.com/news/home/20151005005578/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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