CEL-SCI Corporation Releases Letter to Shareholders
May 24 2017 - 7:00AM
Business Wire
The following letter is being released by CEL-SCI Corporation
(NYSE MKT:CVM) to its shareholders:
Dear Fellow Shareholders:
We are giving you an update on clinical hold communications with
the U.S. Food and Drug Administration (FDA), the “Agency”,
regarding the previously announced partial clinical hold of
CEL-SCI's Phase 3 clinical trial of its investigational drug
Multikine* (Leukocyte Interleukin, Injection) in patients with
squamous cell carcinoma of the head and neck.
The partial clinical hold on this ongoing Phase 3 head and neck
cancer trial with 928 patients enrolled covered a range of issues
previously described to the shareholders. Following a Type A
meeting with the FDA in February 2017, we filed a response that was
intended to address all of these issues in April, 2017. As part of
our response to address the FDA concerns expressed in item 3 of the
October 15, 2016 letter from the FDA to us, we submitted a proposed
update to the Investigator’s Brochure (IB) and a proposed “Dear
investigator” letter which we planned to distribute following the
FDA’s review and approval. In its most recent communication in May
2017, the FDA stated: “We have completed the review of your April
19, 2017, submission and have concluded that removal of the
clinical hold is not warranted since item 3 of the October 15, 2016
letter has not been resolved. In addition, we have identified new
deficiencies in your April 19, 2017, submission.” The FDA directed
that: 1) The IB and the “Dear investigator” letter should contain
specific statements and data which were not included in the
proposed texts we had submitted in April 2017 and 2) Some of the
statements that were included in the proposed texts accompanying
our April 2017 response should be removed. Work on revising the IB
and the “Dear investigator” letter in accordance with the FDA’s
directions has already begun and we hope to resubmit the amended
documents to the FDA for their review and approval very soon. We
are hopeful that the FDA will consider the amended documents
satisfactory and will consider lifting the clinical hold.
In the Agency’s May 2017 letter, the FDA also stated: “Until you
have submitted the required information and we notify you that you
may initiate clinical studies, this IND remains on clinical hold
and you may not legally initiate or resume clinical studies under
it.” The heading on the FDA May 2017 letter is “Continue Full
Clinical Hold”, whereas the heading on previous hold letters was
“Partial Clinical Hold”. The FDA communicated to us that the IND is
on Full Clinical Hold because the exception to the full hold
(Patients enrolled in our Phase 3 head and neck cancer protocol
prior to September 26, 2016, may continue to receive
protocol-specified treatment at the discretion of the treating
physician) no longer exists, since all patients had completed
planned treatment with our investigational product, Multikine.
Placing the IND on full hold does not result in termination of the
Phase 3 head and neck cancer trial and all protocol-specified data
collection will continue as described in the protocol, but we may
not enroll new patients and may not resume investigational product
(Multikine) dosing in any previously enrolled patient. In the
Agency’s May 2017, letter, the FDA stated, “Finally, since there
are no patients currently receiving Multikine under this IND and
the only study being conducted under this IND (Study CA001P3) is
closed to accrual, we have concluded that all studies covered by
this IND must be placed on clinical hold; proposed studies may not
be initiated, and ongoing studies are suspended.” It should be
noted that, at present, CEL-SCI is not conducting other studies
with Multikine under this IND other than the ongoing Phase 3 study
which is subject to the clinical hold, no other studies are planned
in the immediate future, and an amendment to the Phase 3 head and
neck cancer study will be filed only if required. Our study
investigating the use of Multikine as a potential treatment in HPV
related disease is being conducted under a different IND.
We are continuing to work extremely hard to bring our Phase 3
trial to a successful conclusion, to have the FDA's clinical hold
lifted, and to win the arbitration case against the former CRO that
originally ran our Phase 3 trial.
We thank you for your continued support of the Company.
Sincerely,
Geert KerstenChief Executive Officer
Forward-Looking Statements
This letter 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 letter, 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 and that
is currently subject to a clinical hold.
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version on businesswire.com: http://www.businesswire.com/news/home/20170524005345/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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