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): August 19, 2008
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 Blvd. #802
Vienna, VA 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)
Item 8.01. Other Events
On August 19, 2008 CEL-SCI entered into an agreement with Teva Pharmaceutical
Industries Ltd. (Teva), a leading global pharmaceutical company, under which
CEL-SCI granted Teva an exclusive license to market and distribute CEL-SCI's
cancer drug Multikine in Israel and Turkey (the "Territory"). Although the
licensing agreement is initially restricted to the areas of head and neck
cancer, Teva has the right, subject to certain conditions, to include other
cancers during the term of the agreement. Multikine is currently thought to be
potentially useful in treating many tumor types.
Pursuant to the agreement, Teva will participate in CEL-SCI's upcoming global
Phase III clinical trial. Teva will fund a portion of the Phase III clinical
study and Teva's clinical group will conduct part of the clinical study in
Israel under the auspices of CEL-SCI and its Clinical Research Organization.
Teva will also be responsible for registering Multikine in the Territory. If
Multikine is approved, CEL-SCI will be responsible for manufacturing the
product, while Teva will be responsible for sales in the Territory. Revenues
will be divided equally between CEL-SCI and Teva.
CEL-SCI is developing Multikine for approval as a first line indication in head
and neck cancer. To that end, CEL-SCI's upcoming Phase III clinical trial is an
800 patient clinical study designed to demonstrate that administration of
Multikine to head and neck cancer patients before they receive any conventional
cancer treatment will increase their survival. Head and neck cancer is one of
the world's most common cancers affecting about 600,000 people per year.
In Phase II clinical trials Multikine was shown to be safe and well-tolerated
and improved the patients' overall survival by 33% at a median of three and a
half years following surgery. The U.S. Food and Drug Administration (FDA) gave
the go-ahead for a Phase III clinical trial with Multikine in January 2007 and
granted orphan drug status to Multikine in the neoadjuvant therapy of squamous
cell carcinoma (cancer) of the head and neck in May 2007. In the summer of 2007
CEL-SCI started construction of a manufacturing facility to produce Multikine
for the Phase III trial and subsequent sales. This facility is expected to be
completed soon.
Multikine, a patented defined mixture of naturally derived cytokines, is the
first immunotherapeutic agent in a new class of drugs called "Immune
SIMULATORS". Immune SIMULATORS simulate the way the human body's natural immune
system acts in defending against cancer. As opposed to other immunotherapies
which are designed to target a single or limited number of specific antigens or
molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a
direct and targeted killing of the specific tumor cells and activate the immune
system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a
first-line standard of care treatment for cancer. It can be administered prior
to any other cancer therapy since that is the period when the anti-tumor immune
response can still be fully activated. Once the disease has advanced, and the
patient has received radiation and/or chemotherapy, the immune system is
severely weakened and is less able to mount an effective anti-tumor immune
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response. Other immunotherapies are administered after the patient has received
chemotherapy and/or radiation, which can limit their effectiveness.
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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: August 25, 2008
CEL-SCI CORPORATION
By: /s/ Patricia B. Prichep
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Patricia B. Prichep
Senior Vice President of Operations