CEL-SCI Reports March 2014 is Record Month for Patient Enrollment in Phase III Head and Neck Cancer Trial
01 April 2014 - 11:30PM
Business Wire
Accelerating pace of patient enrollment
driven by commitment and capabilities of new CROs and increasing
number of clinical centers participating in the trial
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
during the month of March the Company enrolled 14 patients with
advanced primary, not yet treated, head and neck cancer into its
global Phase III head and neck cancer trial. This marks the largest
number of patients enrolled in the Company’s trial with its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) in any month to date.
CEL-SCI’s trial, the largest Phase III head and neck cancer
trial in the world, is now active in 12 countries through about 40
clinical sites. During the month of March five clinical centers
were added to the study. By the end of 2015 the study is expected
to complete enrollment of 880 patients through over 100 clinical
centers. As the number of clinical centers increases, patient
enrollment is scheduled to accelerate each month.
“In the balance of 2014 and 2015 we plan to add about 60
additional clinical centers to our study. With our new clinical
research organizations, Ergomed and Aptiv Solutions, on board we
are confident that we will meet our objective of completing patient
enrollment by the end of 2015. We anticipate consistent
month-over-month increases in the number of new patients enrolled,”
commented CEL-SCI Chief Executive Officer Geert Kersten.
Multikine was well tolerated and used safely in CEL-SCI’s Phase
II studies in head and neck cancer, as reported by the Phase II
study investigators. In the trial, which formed the basis for the
Phase III study, Multikine administration appeared to have caused,
on average, the disappearance of about 50% of the cancer cells of
treated patients. Based on pathology reports, 12% of patients had
no remaining cancer cells after treatment with Multikine. These
results were published 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 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 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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