CEL-SCI Announces Update on Arbitration against Former Clinical Research Organization
November 13 2017 - 7:30AM
Business Wire
CEL-SCI Corporation (NYSE American:CVM) announced today
an update on its arbitration with its former clinical research
organization (CRO). The last witness in the arbitration hearing
testified on Wednesday, November 8, 2017, and no further witnesses
or testimony are expected. With that final witness, the testimony
phase of the arbitration concluded. All that remains at the trial
level are closing statements and post-trial submissions.
In 2013, CEL-SCI filed an arbitration seeking $50 million from
its former CRO that used to run the Company’s Phase 3 head and neck
cancer study with Multikine. CEL-SCI's arbitration claim alleges
(i) breach of contract, (ii) fraud in the inducement, and (iii)
common law fraud.
The former CRO was replaced in the spring of 2013 and the
Company’s Phase 3 head and neck cancer study has enrolled nine
hundred twenty-eight (928) newly diagnosed head and neck cancer
patients. All the patients who have completed treatment continue to
be followed for protocol-specific outcomes in accordance with the
study protocol.
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. 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. The Company’s LEAPS technology is being developed
as a therapeutic vaccine for rheumatoid arthritis and is supported
by grants from the National Institutes of Health. CEL-SCI has
patents on Multikine from the US, Europe, China, and Japan.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171113005444/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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