CEL-SCI Gives Update on Partial Clinical Hold on Phase 3 Head and Neck Cancer Study with Multikine
March 06 2017 - 7:00AM
Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) announces that it has
received the official minutes from its February 8, 2017 meeting
with the U.S. Food and Drug Administration (FDA) in regards to the
partial clinical hold placed on the Phase 3 head and neck cancer
study with CEL-SCI’s investigational drug Multikine* (Leukocyte
Interleukin, Injection) on September 26, 2016. Pursuant to this
partial clinical hold, patients currently receiving study
treatments can continue to receive treatment at the discretion of
their physicians and with their consent, and patients already
enrolled in the study will continue to be followed. 928 patients
are enrolled in this study.
The purpose of the Type A (face-to-face) meeting with the FDA
was to allow an open and frank discussion of the clinical hold
issues raised by the FDA and to secure the FDA’s input and
clarification on how to address the partial hold issues.
The Action Items for CEL-SCI to pursue per the minutes from the
FDA are the following:
1) Provide an updated Investigator’s Brochure
and current procedures for compliance with requirements under 21
CFR 312 Subpart D to address the partial clinical hold.
2) Provide a list of major protocol
deviations, which CEL-SCI believes will affect study results, and
provide a plan to identify major protocol deviations across all
patients enrolled in the Phase 3 protocol.
CEL-SCI is working diligently on responding to all action
items.
CEL-SCI is giving the FDA issues top priority. It is our belief
that addressing the Action Items listed above will support a
favorable decision by the FDA to lift the partial clinical hold.
While we think that we have understood the Action Items, it is
possible that we have not understood all issues involved. All of
our work is subject to the FDA's review of our submission upon its
completion and may or may not result in the lifting of the partial
clinical hold.
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. Subject to the
partial clinical hold, the study was designed with the objective
that, 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
(treatment of cervical dysplasia in HIV/HPV co-infected women) has
been completed at the University of Maryland. The latter indication
(treatment of peri-anal warts in HIV/HPV co-infected men and women)
is being studied in a Phase 1 trial at the University of
California, San Francisco. CEL-SCI has 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, 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.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. 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 and that
is currently subject to a clinical hold on enrollment of additional
new patients.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170306005667/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Apr 2024 to May 2024
Cel Sci (AMEX:CVM)
Historical Stock Chart
From May 2023 to May 2024