CEL-SCI Expands its Global Phase III Immunotherapy Head & Neck Cancer Trial into Centre Hospitalier Universitaire de Quebec i...
August 19 2014 - 8:00AM
Business Wire
CHUQ is the latest medical center to join
CEL-SCI’s trial in North America
CEL-SCI Corporation (NYSE MKT:CVM) today announced its
Phase III Head and Neck Cancer clinical trial of its
investigational cancer immunotherapy treatment Multikine*
(Leukocyte Interleukin, Injection) has added Centre Hospitalier
Universitaire de Québec (CHUQ)’s L’Hotel Dieu de Quebec to its
growing number of clinical sites in North America. CHUQ is a
network of three teaching hospitals affiliated with the medical
school of Université Laval and several specialized institutions in
Quebec City. CEL-SCI plans to activate additional clinical sites
for accelerated patient enrollment in Canada.
The Principal Investigator for CEL-SCI’s Phase III trial at CHUQ
is Dr. André Fortin, a radiation oncologist and visiting professor.
He is responsible for the research protocols of radiation therapy
for the oncology group at CHUQ. Dr. Fortin has extensive expertise
in the treatment of cancers using radiation therapy for head and
neck, pulmonary, and digestive cancers. He is very involved in
clinical research within the department as evidenced by his
numerous publications.
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. CEL-SCI’s
Multikine investigational immunotherapy is intended to create an
anti-tumor immune response to reduce local/regional tumor
recurrence and thereby increase the survival rate of these
patients.
“We are adding many additional centers in Canada and the U.S.
for the world’s largest Phase III trial in head and neck cancer.
This will hopefully keep us on schedule to complete global
enrollment with approximately 880 patients by the end of 2015,”
stated CEL-SCI Chief Executive Officer Geert Kersten.
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
investigational 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 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 U.S.
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’s work is focused on finding the best way to activate
the immune system to fight cancer and infectious diseases. Its lead
investigational therapy Multikine (Leukocyte Interleukin,
Injection) is currently being studied in a pivotal Phase III
clinical trial against head and neck cancer. If the study endpoint,
which is a 10% improvement in overall survival of the subjects
treated with Multikine treatment regimen as compared to subjects
treated with current standard of care only is satisfied, the study
results will be used to support applications which will be
submitted to regulatory agencies in order to receive from these
agencies commercial marketing approvals for Multikine in major
markets around the world. Additional clinical indications for
Multikine which are being investigated include cervical dysplasia
in HIV/HPV co-infected women, and the treatment of peri-anal warts
in HIV/HPV co-infected men and women. A Phase I trial of the former
indication has been completed at the University of Maryland. The
latter indication is now in a Phase I trial in conjunction with the
U.S. Navy under a CRADA (Cooperative Research and Development
Agreement).
CEL-SCI is also developing its LEAPS technology for the
treatment of pandemic influenza and as a potential therapeutic
vaccine against rheumatoid arthritis. The Company has recently
received a Phase I SBIR Grant from the NIH to develop LEAPS as a
potential treatment for RA with Rush University researchers. 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 press release, 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,
703-506-9460www.cel-sci.com
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