U.S. FDA Removes Clinical Hold on CEL-SCI’s Phase 3 Head & Neck Cancer Trial
August 14 2017 - 7:00AM
Business Wire
The Study’s 928 patients are being monitored
and continue to be followed for protocol-specific outcomes
CEL-SCI Corporation (NYSE American: CVM) today announced
it has received a letter from the U.S. Food and Drug Administration
(FDA) stating that the clinical hold that had been imposed on the
Company’s Phase 3 cancer study with Multikine* (Leukocyte
Interleukin, Inj.) has been removed and that all clinical trial
activities under this Investigational New Drug application (IND)
may resume.
Multikine is being studied as a potential first-line (before any
other cancer treatment is given) immunotherapy that is aimed at
harnessing the patient’s own immune system to produce an anti-tumor
response. Nine hundred twenty-eight (928) newly diagnosed head and
neck cancer patients have been enrolled in this Phase 3 cancer
study and all the patients who have completed treatment continue to
be followed for protocol-specific outcomes in accordance with the
Study Protocol.
The study’s primary endpoint is a 10% increase in overall
survival for patients treated with the Multikine treatment regimen
plus standard of care (SOC) versus those who receive SOC only. The
determination if the study’s primary end point has been met will
occur when there are a total of 298 deaths in those two groups.
Current SOC for this indication is surgery, followed by radiation
therapy alone or followed by concurrent radio-chemotherapy.
There is a clear and unmet medical need for a new treatment in
this indication as the last FDA approved treatment for advanced
primary head and neck cancer was over 50 years ago. The FDA has
also designated Multikine an Orphan Drug for neoadjuvant therapy in
patients with squamous cell carcinoma of the head and neck
(SCCHN).
About Head and Neck Cancer
Head and neck cancer describes squamous cell carcinomas located
inside the neck, mouth, nose, and throat. According to the World
Health Organization, the annual incidence of head and neck cancer
is approximately 550,000 cases worldwide, with about 300,000 deaths
each year. Risk factors involved with head and neck cancer include
heavy alcohol use, tobacco use, and the cancer causing type of
human papilloma virus (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. The
Company has operations in Vienna, Virginia, and in/near Baltimore,
Maryland.
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'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, 2016. 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 (Leukocyte Interleukin, Injection) 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 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. 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 in progress.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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