CEL-SCI CORPORATION
(Amex: CVM) announced today that its cancer drug Multikine(R) was shown to
significantly increase long term overall survival in a Phase II study of
head and neck cancer patients. The data were presented on May 20, 2007 at
the First International Congress of the International Association of Oral
Oncology in Amsterdam, the Netherlands, by Dr. Eyal Talor, Senior VP of
Research and Manufacturing at CEL-SCI Corporation.
Dr. Talor's presentation focused on the results obtained in CEL-SCI's
final Phase II clinical trial of Multikine that was conducted in patients
with head and neck cancer (oral squamous cell carcinoma -- OSCC). This
final Phase II clinical trial was designed to assess thoroughly the
positive safety and efficacy observations made in patients treated with
Multikine in CEL-SCI's early Phase II trials. In the trial Multikine was
given prior to standard care to recently diagnosed and not yet treated
cancer patients.
The addition of Multikine to the first treatment (standard of care) of
these patients resulted in a 33% improvement in the median overall survival
at 3-1/2 years post-surgery, when compared to the survival results reported
in 55 OSCC clinical trials published in the scientific literature between
1987 and 2007.
Multikine first-line treatment also resulted in an improvement of the
2- year local regional over the published local regional control rate. It
is clinically recognized that recurrence of disease in head and neck cancer
is associated with a very poor prognosis. Multikine treatment did not
result in any severe adverse events (SAE) in this Phase II clinical trial
and no SAEs related to Multikine have been reported in other trials
conducted with Multikine either.
CEL-SCI received clearance from the United States Food and Drug
Administration (FDA) to proceed to a Phase III clinical trial with
Multikine earlier this year. The same treatment regimen that was used in
CEL-SCI's final Phase II trial will be used in the upcoming Phase III trial
that CEL-SCI will undertake since the results obtained in the final Phase
II trial are thought to be indicative of the results one might expect in
any Phase III trial of Multikine. The Phase III trial is designed to
demonstrate a 10% increase in overall survival of patients treated with
adjuvant Multikine therapy versus those treated only with the current
standard of care.
Dr. Talor said, "Having shown a 33% increase in overall survival with
no safety concerns in the final Phase II study, we are very hopeful that we
will successfully reach the 10% increase in overall survival that is the
primary endpoint of our Phase III trial. To further enhance the probability
of meeting our primary endpoint, we are over-enrolling the study."
Documented data were available for 19 of the 22 patients in the
follow-up portion of this clinical trial. Of the three patients who could
not be evaluated in the follow-up study, one patient was known to be alive,
but failed to give informed consent, and the other two were lost to
follow-up. One patient died the day after definitive surgery, unrelated to
Multikine therapy.
Head & neck cancer is an aggressive cancer that affects over 500,000 -
600,000 people per annum worldwide.
CEL-SCI Corporation is developing new immune system based treatments
for cancer and infectious diseases. The Company has received the go-ahead
from the U.S. FDA and the Canadian Regulators to conduct a Phase III
clinical trial in advanced primary head and neck cancer patients with its
lead product Multikine. CEL-SCI's other products, which are currently in
pre-clinical stage and have been funded with U.S. government support, have
shown protection against a number of diseases in animal tests and are
currently being tested against diseases associated with bio-defense and
avian flu. The Company has operations in Vienna, Virginia and Baltimore,
Maryland.
When used in this report, the words "intends," "believes,"
"anticipated" and "expects" and similar expressions are intended to
identify forward-looking statements. Such statements are subject to risks
and uncertainties which 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 SEC filings,
including but not limited to its report on Form 10- K for the year ended
September 30, 2006. 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.
CEL-SCI Corporation
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