CEL-SCI Receives Authorization to Conduct Its Phase 3 Multikine Trial in Italy
May 13 2015 - 9:00AM
Business Wire
Italy is 23rd country to
authorize CEL-SCI’s trial for patient enrollment
CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the
“Company”) today announced that the Italian Medicines Agency (AIFA)
has authorized the Company to commence patient enrollment for its
ongoing Phase 3 trial of its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection) in patients with
advanced primary squamous cell carcinoma of the oral cavity/soft
palate, a type of head and neck cancer. Italy is the 23rd country
to authorize CEL-SCI’s Phase 3 trial for patient enrollment.
Having surpassed its originally planned milestone of receiving
authorization to conduct the Phase 3 study from 21 countries,
CEL-SCI is now aiming to expand the trial into a total of
approximately 100 clinical centers in about 25 countries. As of
April 30, 2015, 437 patients had been enrolled in the global Phase
3 study.
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced
primary squamous cell carcinoma of the head and neck. The objective
of the study is to demonstrate a statistically significant
improvement in the 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 an
open-label, randomized, controlled, global pivotal Phase 3 clinical
trial as a potential first-line treatment for advanced primary
squamous cell carcinoma of the head and neck. Multikine is designed
to 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.
Multikine is also being tested in a Phase 1 study under a
Cooperative Research and Development Agreement (“CRADA”) with the
U.S. Naval Medical Center, San Diego, as a potential treatment for
peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has
also entered into two co-development agreements with Ergomed
Clinical Research Limited to further the 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’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 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. If the study
endpoint, which is a 10% improvement in overall survival of the
subjects treated with the Multikine treatment regimen plus the
current SOC as compared to subjects treated with the current SOC
only, is satisfied, the study results will be used to support
applications that the Company plans to submit to regulatory
agencies in order to seek commercial marketing approvals for
Multikine in major markets around the world. Additional clinical
indications for Multikine that are being investigated include the
treatment of 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 1 trial of the former indication has been completed
at the University of Maryland. The latter indication is now in a
Phase 1 trial in conjunction with the U.S. Naval Medical Center,
San Diego, under a CRADA.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) technology for the potential
treatment of pandemic influenza in hospitalized patients and as a
potential vaccine for the treatment of rheumatoid arthritis.
The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland. For more information, please visit
www.cel-sci.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. 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 that 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 filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K and 10-K/A for
the year ended September 30, 2014. 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.
*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 the Company’s 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 have 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 Phase 3 clinical trial of
this investigational therapy that is currently in progress.
CEL-SCI CorporationGavin de Windt, 703-506-9460
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