SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (date of earliest event reported): January 16, 2007
CEL-SCI CORPORATION
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(Exact name of Registrant as specified in its charter)
Colorado 0-11503 84-0916344
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(State or other jurisdiction (Commission File No.) (IRS Employer
of incorporation) Identification No.)
8229 Boone Boulevard, Suite 802
Vienna, Virginia 22182
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(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (703) 506-9460
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N/A
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(Former name or former address if changed since last report)
Check appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below)
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-14(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On January 16, 2007, the Company issued a press release regarding the
notification from the FDA that it had no objection to the Company beginning a
Phase III clinical trial using Multikine to treat head and neck cancer. A copy
of this press release is attached as an exhibit.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: January 18, 2007
CEL-SCI CORPORATION
By: /s/ Geert R. Kersten
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Geert R. Kersten, Chief Executive Officer
EXHIBIT 99
CEL-SCI
Corporation NEWS RELEASE
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8229 Boone Boulevard, Suite 802
Vienna, VA 22182. USA COMPANY CONTACT:
Telephone (703) 506-9460 Gavin de Windt
Fax (703) 506-9471 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
CEL-SCI RECEIVES GREEN LIGHT FROM FDA
TO PROCEED WITH PHASE III CANCER STUDY
VIENNA, VA, USA, JANUARY 16, 2007 -- CEL-SCI Corporation (AMEX: CVM, Germany:
LSR.F) 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.
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