CEL-SCI
Corporation (NYSE MKT: CVM) today announced it has expanded
its Phase III Head and Neck Cancer clinical trial of its investigational
cancer immunotherapy treatment Multikine* (Leukocyte Interleukin,
Injection) in the U.S. with the addition of a new site in Scottsdale,
Arizona. The 21st
Century Oncology clinic in Scottsdale, along with the Arizona
Cancer Research Alliance, has just joined the study and is actively
screening patients for enrollment into the trial. The Multikine Phase
III study is enrolling patients with advanced primary, not yet treated,
head and neck cancer.
“Our clinical trial is now active in over 40 medical centers
internationally and we are pleased to expand the number of sites in the
U.S. More American patients now have the option of enrolling in this
trial for Multikine, which aims to use the body’s own natural immune
system to fight cancer. We look forward to working with 21st Century
Oncology, and the Arizona Cancer Research Center to bring the potential
of this innovative new method of treating cancer patients to Arizona,”
stated CEL-SCI Chief Executive Officer Geert Kersten.
The Arizona Cancer Research Alliance (ACRA) is a community-based network
for testing and validating medical interventions with the potential to
diagnose, treat, ameliorate or cure cancer. The alliance is focused on
creating infrastructure to support physicians who are believed to be
responsible for over 80% of the care provided to patients with cancer.
21st Century Oncology is the largest global, physician-led provider of
integrated cancer care services, operating 166 treatment centers, with
133 centers in 16 states in the U.S. and 33 centers in six Latin
American countries.
The Principal Investigator for the Scottsdale site is Dr.
Steven Finkelstein, whose clinical expertise includes radiation
oncology, surgical oncology and clinical immunotherapy in the treatment
of head and neck malignancies, prostate, breast, lung, and colorectal
cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation
Oncologist, National Director of the Translational Research Consortium,
Adjunct Associate Professor at Translational Genomic Research Institute,
and Executive Director of the Arizona Cancer Research Alliance.
21st Century Oncology’s Scottsdale clinic is the
organization’s second clinic to join CEL-SCI’s trial as part of the
CEL-SCI trial expansion. CEL-SCI recently
announced 21st Century Oncology’s Greenville, North
Carolina site had also joined the study.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an immunotherapeutic
agent that is being tested in a global, multi-center, randomized,
controlled, 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 the clinical development of 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