VIENNA, Va., May 23 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION
(Amex: CVM) announces the presentation of long-term survival data from its
Phase II clinical trial in patients with head & neck cancer (oral squamous
cell carcinoma -- OSCC) treated with its anti-cancer drug Multikine(R). The
addition of Multikine as first-line treatment prior to the standard of care
treatment resulted in a 33-40% improvement in the median survival at 3 1/2
years post-surgery, when compared to the results of 39 OSCC clinical trials
published in the scientific literature between 1987 and 2004. The data were
presented at the "Vaccine Discovery and Commercialization" conference in
Philadelphia, PA.
The long-term survival data were collected by the treating physicians
in a follow-up study of 22 patients with advanced untreated primary tumors,
who were enrolled in the Multikine Phase II clinical trial. The Multikine
treatment regimen was administered to these patients prior to the standard
of care treatment (i.e., surgery + radiation or surgery + chemo-radiation).
Informed consent was obtained from all patients in the clinical trial and
from 19 patients for the long-term follow-up study. Investigational Review
Board / Ethics Committee approval was provided before the initiation of the
clinical trial and again for the data collection in the follow-up study.
The follow-up study questionnaire assessed the overall survival and the
local regional control of the Multikine treated patients in this Phase II
trial.
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.
The median overall survival (calculated by including death from any
cause of patients in the trial, even deaths not related to the disease) of
the 19 evaluable patients in the follow-up portion of this clinical trial
was 63% at a median follow-up of 40 months post-surgery. The results of the
published scientific literature (39 OSCC clinical trials published between
1987 and 2004) document that survival at 3 1/2 years is approximately 47%
following standard of care treatment. The addition of Multikine to the
standard of care treatment resulted in a 33% increase in overall survival
over the results published in the literature.
The median survival of patients in this clinical trial was 67% at a
median follow-up of 42 months post-surgery, excluding the one patient with
immediate post-operative death. The same 39 scientific publications
indicate that survival at 3 1/2 years is approximately 47% following
standard of care treatment. The addition of Multikine to the standard of
care treatment resulted in an increase in survival of 40% over the results
published in the literature.
Multikine first-line treatment also resulted in a 2-year local regional
control (LRC) rate of 79%, as compared to the median 2-year LRC of 73%
reported in the same 39 scientific publications. Multikine treatment
resulted in an improvement over the published local regional control rate.
It is clinically recognized that recurrence of disease in head & 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. No SAEs related to Multikine have been
reported in other trials conducted with Multikine either.
The data from CEL-SCI's Multikine Phase II clinical trial are thought
to be directly applicable to CEL-SCI's planned global Phase III clinical
trial, as the Multikine treatment regimen planned in the Phase III trial is
identical to that of the Multikine treatment in the trial reported here.
Furthermore, the planned endpoints of the Phase III trial are local
regional control, disease-free survival and overall survival, all of which
have shown improvement compared to historical controls, following Multikine
first-line treatment over the current available treatments for these
patients.
Head & neck cancer is an aggressive cancer that affects 500,000 people
per annum worldwide, and approximately 2/3 of patients present with
advanced disease.
Multikine is a patented immunotherapeutic agent consisting of a mixture
of naturally-occurring human cytokines, including interleukins,
interferons, chemokines and colony-stimulating factors, currently being
developed for the treatment of cancer.
CEL-SCI Corporation, with operations in Vienna, VA and Baltimore, MD is
developing new immune system based treatments for cancer and infectious
diseases. CEL-SCI's other products are currently in the pre-clinical stage
of development. Pre-clinical animal studies have received U.S. government
support. The results of these studies indicate these products may offer
protection against a number of diseases. The agents are being tested, among
others, against diseases associated with bio-defense and avian (bird) flu.
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, 2005. 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.
SOURCE CEL-SCI Corporation
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Related links:
http://www.cel-sci.com
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460, or Investor Relations: Mike Lucci of Lucci
Financial Group, LLC, +1-248-723-3330, for CEL-SCI Corporation
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