CEL-SCI
Corporation (NYSE MKT:CVM) today announced that in 2014 it
enrolled close to 200 patients with advanced primary, not yet treated,
head and neck cancer into its global pivotal Phase III head and neck
cancer trial for its investigational immunotherapy Multikine* (Leukocyte
Interleukin, Injection). This annual enrollment represents an eight-fold
increase over enrollment of 24 patients in 2013, the year during which
CEL-SCI dismissed its prior clinical research organization (CRO) and
replaced it with new CROs, Aptiv and Ergomed. Twenty one (21) patients
were enrolled in the study during the month of December.
“During 2014 we enrolled more patients than we did in several years when
we worked with our prior CRO. As we continue to work with our new CROs,
we expect strong continued growth in monthly and quarterly patient
enrollment for the balance of 2015,” stated CEL-SCI Chief Executive
Officer Geert Kersten.
A total of 880 patients are expected to be enrolled through
approximately 100 clinical centers in about 20 countries by the end of
2015 in the world’s largest Phase III trial for head and neck cancer.
328 patients have been enrolled in the study by the end of December 2014.
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.
The trial is expected to expand into a total of approximately 100
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, 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.
Copyright Business Wire 2015