CEL-SCI Receives Regulatory Clearance to Expand Phase III Head and Neck Cancer Trial into Turkey
July 22 2014 - 8:30AM
Business Wire
16th country to participate in
world’s largest phase III trial in head and neck cancer
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
Turkey’s Ministry of Health has cleared the company to begin
patient enrollment in CEL-SCI’s global pivotal Phase III Head and
Neck Cancer clinical trial of its investigational cancer
immunotherapy treatment Multikine* (Leukocyte Interleukin,
Injection). The Company expects to enroll patients through three
clinical centers in Turkey. Turkey thus becomes the 16th country to
participate in the world’s largest Phase III head and neck cancer
trial.
“As we add more countries and subsequently more clinical
centers, we see an acceleration of the pace of the Phase III trial.
In the most recently reported three month period, we saw a 93%
increase in patient enrollment over the prior three month period,”
stated CEL-SCI Chief Executive Officer Geert Kersten. “We are
pleased with the progress of our clinical program as we investigate
the efficacy of Multikine immunotherapy to treat cancer.”
Head and neck cancer accounts for about 6% of all cancers, with
approximately 600,000 new cases reported annually worldwide.
CEL-SCI has received U.S. Orphan Drug designation for Multikine in
head and neck cancer in the US.
Further expansion of the Phase III trial is underway with a goal
to have a total of 880 patients enrolled through about 100 clinical
centers by the end of 2015. Over 220 patients have been enrolled in
the study to date.
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 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
immunotherapeutic agent that is being tested in a 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. The trial is expected to expand
into a total of approximately 100-110 clinical centers in about 20
countries.
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. 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 women who are
co-infected with HIV and HPV and for peri-anal warts in men and
women who are co-infected with HIV and HPV.
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 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 (Cooperative Research and Development
Agreement).
CEL-SCI is also developing its LEAPS technology for the
treatment of pandemic influenza and as a potential therapeutic
vaccine against rheumatoid arthritis. 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, 2013. 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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