CEL-SCI Completes Key Milestone with Clearance to Conduct Phase III Trial in 21 Countries
February 27 2015 - 3:22PM
Business Wire
Belarus is 21st country to
clear CEL-SCI’s trial for patient enrollment
CEL-SCI Corporation (NYSE MKT: CVM) today announced the
Ministry of Health of the Republic of Belarus has cleared the
Company to commence patient enrollment for its Phase III head and
neck cancer trial of its investigational cancer immunotherapy
treatment Multikine* (Leukocyte Interleukin, Injection). Belarus is
the 21th country to approve CEL-SCI’s Phase III trial.
“This means that CEL-SCI has now reached a key milestone in this
pivotal Phase III clinical trial, receiving clearance in the
planned 20 countries in addition to the United States. Well over 10
countries have been added to the study since we dismissed the prior
clinical research organization (CRO). With the very large increase
in enrollment in the study under the new CRO, we now also see
strong interest from doctors and clinical centers in other
countries too. Therefore, we are working on further expanding this
global trial beyond the 21 countries in which we are already
cleared to conduct the study. We expect that expanding the
geography of the trial will yet further accelerate patient
recruitment,” stated CEL-SCI Chief Executive Officer Geert
Kersten.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with
advanced primary, not yet treated, head and neck cancer. 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 III
clinical trial as a potential first-line treatment for advanced
primary head and neck cancer. If approved for use following
completion of CEL-SCI's clinical development program for head and
neck cancer, Multikine would 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. CEL-SCI is aiming to complete enrollment of subjects to the
Phase III head and neck cancer study by the end of 2015.
In October 2013, CEL-SCI announced that it had signed a CRADA
(Cooperative Research and Development Agreement) with the US Naval
Medical Center, San Diego, to develop Multikine as a potential
treatment for HIV/HPV co-infected men and women with peri-anal
warts. The Phase I trial started enrolling patients in September
2014. CEL-SCI also entered into two new co-development agreements
with Ergomed to further clinically develop Multikine for cervical
dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal
warts in HIV/HPV co-infected men and women.
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. CEL-SCI
believes that the best way may be to activate the immune system of
patients before they have received surgery, radiation and/or
chemotherapy. Its lead investigational therapy Multikine (Leukocyte
Interleukin, Injection) is currently being studied in a pivotal
Phase III clinical trial against head and neck cancer. If the study
endpoint, which is a 10% improvement in overall survival of the
subjects treated with Multikine treatment regimen as compared to
subjects treated with current standard of care only is satisfied,
the study results will be used to support applications which will
be submitted to regulatory agencies in order to receive from these
agencies commercial marketing approvals for Multikine in major
markets around the world. Additional clinical indications for
Multikine which are being investigated include 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 I trial of the former
indication has been completed at the University of Maryland. The
latter indication is now in a Phase I trial in conjunction with the
U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the
treatment of pandemic influenza and as a potential therapeutic
vaccine against rheumatoid arthritis. CEL-SCI received a Phase I
SBIR Grant from the National Institutes of Health to develop LEAPS
as a potential treatment for rheumatoid arthritis with researchers
from Rush University Medical Center in Chicago, Illinois. The
Company has operations in Vienna, Virginia, and in/near Baltimore,
Maryland.
For more information, please visit www.cel-sci.com.
* 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 our 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 (Leukocyte Interleukin,
Injection). Further research is required, and early-phase clinical
trial results must be confirmed in the well-controlled, Phase III
clinical trial of this investigational therapy that is currently in
progress.
When used in this report, 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 which 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 SEC
filings, including but not limited to its report on Form 10-K 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.
CEL-SCI CorporationGavin de Windt, 703-506-9460
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