VIENNA, Va., Aug. 19 /PRNewswire-FirstCall/ -- CEL-SCI Corporation
(Amex: CVM) announced today that it has entered into an exclusive licensing
agreement with Teva Pharmaceutical Industries Ltd. (Teva), a leading global
pharmaceutical company, under which CEL-SCI has granted Teva an exclusive
license to market and distribute the Company's cancer drug Multikine for
Israel and Turkey (the "Territory"). The licensing agreement is initially
restricted to the areas of head and neck cancer. Teva has the right,
subject to certain conditions, to extend the licensing agreement to include
other cancers during the term of this 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 the product in
the Territory. Once Multikine has been approved, CEL-SCI will be
responsible for manufacturing the product, while Teva will be responsible
for sales in the Territory. Revenues will be split 50/50 between CEL-SCI
and Teva.
"We believe that Teva's expertise and knowledge in successfully
conducting large pivotal clinical trials and in developing markets for
large unmet medical needs will prove invaluable in maximizing Multikine's
potential. This agreement is consistent with our strategy to share the
clinical and regulatory expenses associated with the development of
Multikine while retaining rights to market Multikine in North America and
Europe," said Geert Kersten, Chief Executive Officer of CEL-SCI.
CEL-SCI is developing Multikine for approval as a first line indication
in head and neck cancer. To that end, the Company's upcoming Phase III
clinical trial is an 800 patient clinical study designed to demonstrate
that administration of its cancer drug 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 biggest
cancers affecting about 600,000 people per annum worldwide.
About CEL-SCI's Phase III Cancer Drug Multikine:
In Phase II clinical trials Multikine was shown to be safe and
well-tolerated, and to improve 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 the
manufacturing facility to produce Multikine for the Phase III trial and
subsequent sale following approval. 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 our natural immune system
acts in defending us 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 they 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 is administered
prior to any other cancer therapy because that is the period when the
anti-tumor immune response can still be fully activated. Once the patient
has advanced disease, or had surgery or has received radiation and/or
chemotherapy, the immune system is severely weakened and is less able to
mount an effective anti-tumor immune response. Other immunotherapies are
administered after the patient has received chemotherapy and/or radiation
therapy, which can limit their effectiveness.
CEL-SCI has operations in Vienna, Virginia and Baltimore, Maryland.
CEL-SCI's other products, which are currently in pre-clinical stage, have
shown protection against a number of diseases in animal tests and are being
tested against diseases associated with bio-defense. Most recently CEL-SCI
announced that its newly discovered rheumatoid arthritis vaccine showed
excellent results in animal tests.
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
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