VIENNA, Va., Jan. 16 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(Amex: CVM), (Germany: LSR) today announced that the U.S. Food and Drug
Administration (FDA) has stated in a letter to the Company that, "...the
proposed Phase III study may proceed at any time." CEL-SCI's Phase III
clinical study is designed to prove that its cancer drug Multikine(R)
increases the survival of head and neck cancer patients.
The study is expected to be conducted in numerous countries around the
world. It is designed to develop conclusive evidence of the efficacy of the
Multikine treatment regimen in advanced primary squamous cell carcinoma of
the oral cavity (head and neck cancer). Upon successful completion of this
study, the data will be included in CEL-SCI's worldwide Marketing
Applications to make Multikine commercially available for the treatment of
this patient population. Head and neck cancer is an aggressive disease
affecting about 500,000 people per annum worldwide.
Geert Kersten, Chief Executive Officer of CEL-SCI, said, "So far
Multikine has been shown to be non-toxic, which is very unusual for a
cancer drug. In Phase II clinical studies with head and neck cancer
patients it also markedly increased survival. Now we will get the chance to
prove that Multikine can extend the survival of these cancer patients."
The global Phase III study will test the hypothesis that the Multikine
treatment regimen, administered locally prior to the current standard
therapy given to patients with advanced primary squamous cell carcinoma of
the oral cavity, will extend the overall survival and enhance the
local/regional control of the disease, while increasing disease free
survival in these patients.
Multikine is a patented immunotherapeutic agent consisting of a defined
mixture of naturally occurring cytokines, including interleukins,
interferons, chemokines and colony-stimulating factors.
CEL-SCI Corporation is developing new immune system based treatments
for cancer and infectious diseases. 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, inability to
get American Stock exchange approval for any transaction 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
thereof or to reflect the occurrence of unanticipated events.
SOURCE CEL-SCI Corporation
 back to top
Related links:
http://www.cel-sci.com
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
|
