CEL-SCI Corporation announced today that it has received verbal notice from the U.S. Food and Drug Administration that its Multikine (Leukocyte Interleukin Injection) Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold.
CEL-SCI Corporation (NYSE MKT:CVM) announced today that it has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Multikine (Leukocyte Interleukin Injection) Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold.
Pursuant to this communication from FDA, patients
currently receiving study treatments can continue to receive treatment,
and patients already enrolled in the study will continue to be followed.
CEL-SCI was also told to expect a formal letter from the FDA within 30
days and will work diligently with the FDA to obtain the release of the
clinical hold. The study currently has about 926 patients enrolled.
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
immunotherapy, 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 an
improvement in overall survival of the subjects treated with the
Multikine treatment regimen plus the current standard of care (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 at UCSF. CEL-SCI has issued patents on Multikine
from the US, Europe, China and Japan.
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,
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 for the
year ended September 30, 2015. 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
*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 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. 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.