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EXHIBIT 99
8229 Boone Boulevard, Suite 802 COMPANY CONTACT:
Vienna, VA 22182. USA Gavin de Windt
Telephone (703) 506-9460 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
U.S. FDA REMOVES CLINICAL HOLD ON
CEL-SCI'S PHASE 3 HEAD & NECK CANCER TRIAL
The Study's 928 patients are being monitored and continue
to be followed for protocol-specific outcomes
Vienna, VA, August 14, 2017 -- 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).
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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