CEL-SCI Reports April 2014 is Another Record Month for Patient Enrollment in Its Phase III Head and Neck Cancer Trial
May 01 2014 - 8:00AM
Business Wire
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.
CEL-SCI CorporationGavin de Windt, 703-506-9460
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