CEL-SCI Corporation (NYSE MKT: CVM) announced today that an
interim review of the safety data from its open label, randomized,
controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin,
Injection) investigational immunotherapy by an Independent Data
Monitoring Committee (IDMC) raised no safety concerns. The IDMC also
indicated that no safety signals were found that would call into
question the benefit/risk of continuing the study. CEL-SCI considers the
results of the IDMC review to be important since studies have shown that
up to 30% of Phase III trials fail due to safety considerations and the
IDMC’s safety findings from this interim review were similar to those
reported by investigators during CEL-SCI’s Phase I-II trials.
Ultimately, the decision as to whether a drug is safe is made by the FDA
based on an assessment of all of the data from a trial.
IDMCs are committees commonly used by sponsors of clinical trials to
protect the interests of the patients in ongoing trials especially when
the trials involve patients with life threatening diseases, and when, as
in cancer clinical trials, they extend over long periods of time (3-5
years). The committee’s membership should include physicians and
clinical trial scientists knowledgeable in the appropriate disciplines,
including statistics. The CEL-SCI IDMC includes prominent physicians and
scientists from major institutions in the USA and abroad who are key
opinion leaders in head and neck cancer and who are knowledgeable in all
of the disciplines related to CEL-SCI’s study, including statistics.
The Multikine Phase III study is enrolling patients with advanced
primary, not yet treated, head and neck cancer on 3 continents around
the world. The objective of the study is to demonstrate a statistically
significant 10% improvement in overall survival of enrolled patients who
are treated with Multikine plus Standard of Care (SOC) vs. subjects who
are treated with SOC only. The universally accepted current standard of
care for the patient population being enrolled in the CEL-SCI study is
surgery plus radiation or surgery plus concurrent radiation and
chemotherapy, dependent on the risk factors for recurrence found after
surgery. Multikine treated patients receive 15 local injections of
Multikine over a 3 week period prior to standard of care treatment.
Multikine injections are administered in the area around the tumor and
in the area of the adjacent lymphnodes since those two areas are where
the tumor is most likely to recur. Multikine is intended to create an
anti-tumor immune response to reduce local / regional tumor recurrence
and thereby increase the survival of these patients.
Multikine is the first immunotherapeutic agent being developed as a
potential first-line treatment for advanced primary head and neck
cancer. If it were to be approved for use following completion of our
clinical development program, Multikine would become an additional and
different kind of therapy in the fight against cancer: one that employs
our body's natural ability to fight tumors.
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" 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, 2011. 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.
