Market Overview

CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

Share:

CEL-SCI Corporation (NYSE:CVM) announced today that the
Independent Data Monitoring Committee (IDMC) for the Company's pivotal
Phase 3 head and neck cancer study of its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection) has completed its recent
review of the Phase 3 study data. The data from all 928 enrolled
patients were provided to the IDMC by the clinical research organization
(CRO) responsible for data management of this Phase 3 study.

The IDMC made the following recommendation:

  • The IDMC recommendation is to continue the trial until the appropriate
    number of events have occurred.

IDMCs are committees commonly used by sponsors of clinical trials to
protect the interests of the patients and the integrity of the study
data in ongoing trials, especially when the trials involve patients with
life threatening diseases, and when, as in cancer clinical trials, they
extend over long periods of time.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is
still intact should provide the greatest possible impact on survival.
Therefore, in the Phase 3 study CEL-SCI treats patients who are newly
diagnosed with advanced primary squamous cell carcinoma of the head and
neck with Multikine first, BEFORE they receive surgery, radiation and/or
chemotherapy. This approach is unique. Most other cancer immunotherapies
are administered only after conventional therapies have been tried
and/or failed. Multikine (Leukocyte Interleukin, Injection), has
received Orphan Drug designation from the FDA for the neoadjuvant
therapy in patients with squamous cell carcinoma (cancer) of the head
and neck.

CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for
the treatment of head and neck cancer. Per the study's protocol, newly
diagnosed patients with advanced primary squamous cell carcinoma are
treated with the Multikine treatment regimen for 3 weeks prior to the
Standard of Care (SOC) which involves surgery, chemotherapy and/or
radiation. Multikine is designed to help the immune system "see" the
tumor at a time when the immune system is still relatively intact and
thereby better able to mount an attack on the tumor. The aim of
treatment with Multikine is to boost the body's immune system prior to
SOC.

The Company's LEAPS technology is currently being developed as a
therapeutic vaccine for rheumatoid arthritis and is supported by grants
from the National Institutes of Health. 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 for the year ended September
30, 2017. 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.

View Comments and Join the Discussion!