The Philippines is the 19th Country to Clear CEL-SCI for Patient Enrollment in Its Phase III Head and Neck Cancer Trial
February 11 2015 - 8:00AM
Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
the Philippines Regulatory Agency (PFDA) has cleared the Company to
commence patient enrollment of the Phase III head and neck cancer
trial of its investigational cancer immunotherapy treatment
Multikine* (Leukocyte Interleukin, Injection) in the Philippines.
Three hospitals in the Philippines are expected to join the
study.
This marks the 19th country to approve CEL-SCI’s Phase III
trial, which is expected to expand into a total of approximately
100 clinical centers in about 20 countries in addition to the U.S.
The trial has over 350 patients enrolled.
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 announced that it 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. Its lead
investigational immunotherapy Multikine (Leukocyte Interleukin,
Injection) is currently being studied in a pivotal Phase III
clinical trial against advanced primary (not yet treated) 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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