CEL-SCI Corporation (NYSE MKT: CVM) today provided an update on
the Phase III Clinical Trial of its investigational drug Multikine*
(Leukocyte Interleukin, Injection) for the treatment of head and neck
cancer. The Company announced that it has hired two clinical research
organizations (CRO’s) who will manage the global Phase III study; Aptiv
Solutions and Ergomed who are both international leaders in managing
oncology trials. Both CRO’s will help the Company expand the trial by
60-80 clinical sites globally. These two CRO’s have replaced the current
CRO managing the study. To date, the study has enrolled 117 patients and
has been conducted at 39 sites in 8 countries, including three centers
in Israel where CEL-SCI’s partner Teva Pharmaceuticals has the marketing
rights, and nine centers in Taiwan where the Company’s partner Orient
Europhama has the marketing rights.
Under a co-development agreement, Ergomed will contribute up to $10
million towards the study where it will perform clinical services in
exchange for a single digit percentage of milestone and royalty
payments, up to a specified maximum amount. Ergomed, a privately-held
firm headquartered in Europe with global operations, has entered into
five similar co-development agreements, including one with Genzyme
(purchased by Sanofi in 2011 for over $20 billion). Ergomed will be
responsible for the majority of the new patient enrollment since it has
a novel model for clinical site management to accelerate patient
recruitment and retention. For example, they have almost 25 physicians
who can directly call on clinical sites to aid recruitment and
retention. Some of the Ergomed physicians also have experience of being
clinical investigators themselves. CEL-SCI believes that this
interaction on a physician to physician level is what is needed to help
physicians increase enrollment in the Multikine study.
“We are pleased that we have partnered with two highly experienced and
committed CRO’s to manage the global Phase III trial going forward,”
said Geert Kersten, CEL-SCI’s CEO. “Each of the CRO’s has assigned
accomplished teams to our study. Ergomed’s co-development agreement to
cover up to $10 million of clinical expenses is important since Ergomed
is responsible for most of the patient enrollment and patient enrollment
is the rate limiting step in the study. We believe that the
co-development model aligns their interests with those of CEL-SCI,
leading to fast enrollment and completion of the study. The Company is
also very familiar with Aptiv’s capabilities, as we have worked with
Aptiv on a number of projects, such as the development of the Phase III
protocol. Both CRO’s have a long and successful track record in
oncology.”
“These changes were necessary as most of the key personnel at the prior
CRO who were involved in our study departed after the CRO was acquired.
This had a very negative effect on study enrollment. As a result, the
number of patients that have been enrolled and treated in the study fell
below the level agreed to with the CRO. However, a sufficient number of
patients have been enrolled to date for the trial to be assessed and
pass the Independent Data Safety and Monitoring Committee (IDMC) initial
safety evaluation of the study in the fall of 2012. We believe that,
with the expanded number of sites and two very focused CRO’s, we will be
able to accelerate the enrollment process significantly and complete the
Study in a timely manner.”
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 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.
Multikine is intended to create an anti-tumor immune response to reduce
local / regional tumor recurrence and thereby increase the survival of
these patients.
CEL-SCI's lead investigational therapy 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 by regulatory agencies (e.g. FDA) 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 aims to employ 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.
* 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, 2012. 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.
