CEL-SCI
Corporation (NYSE MKT: CVM) today announced that during the
month of April 2014 the Company enrolled 21 patients with advanced
primary, not yet treated, head and neck cancer into its global Phase III
head and neck cancer trial for its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection). This marks a substantial
increase over the previous monthly record of 14 patients in March 2014.
CEL-SCI’s trial is now active in 46 clinical centers in 12 countries.
Further expansion is underway to a total of about 20 countries and about
100 clinical centers. So far, 183 patients have been enrolled in the
study.
“During the past months we have seen very rapid increases in rate of
enrollment in this study. We think that increases in the enrollment rate
in our trial in recent months are, in part, due to the addition of new
centers and the intense site support by our clinical research
organization Ergomed. In addition, we have observed a definite increase
in interest by investigators in enrolling subjects in our study once
they have gained some experience with Multikine in their own patients
and once they become more familiar with it. As we continue to add new
centers in our study and as the investigators become more experienced
with using Multikine, we can expect that the rate of enrollment in our
study will continue to increase and make it possible to reach our goal
of full enrollment by the end of 2015,” commented Geert Kersten,
CEL-SCI’s Chief Executive Officer.
Multikine was reported to be well tolerated and was used safely in
CEL-SCI’s Phase II studies in head and neck cancer, as reported by the
Phase II study investigators. In the Phase II trial, which formed the
basis for the Phase III study, Multikine administration appeared to have
caused, on average, the reduction/elimination of about 50% of the cancer
cells of treated patients, as determined by pathology. Also, based on
pathology reports, about 12% of patients had no remaining cancer cells
after their treatment with Multikine Phase II results published (by
Timar et al) in the Journal of Clinical Oncology.
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 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 is dedicated to research and development directed at improving
the treatment of cancer and other diseases by utilizing the immune
system, the body's natural defense system. Its lead investigational
therapy is Multikine (Leukocyte Interleukin, Injection), currently being
studied in a pivotal global Phase III clinical trial. CEL-SCI is also
investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment
for H1N1 hospitalized patients and as a vaccine (CEL-2000) for
Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS
technology platform. The investigational immunotherapy LEAPS-H1N1-DC
treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu
(H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned
about the possible emergence of a new more virulent hybrid virus through
the combination of H1N1 and Avian Flu, or maybe Spanish Flu. 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.
Copyright Business Wire 2014