VIENNA, Va., March 10 CEL-SCI Corporation (NYSE Amex: CVM) announced today that it has received a $125,000 payment from Byron Biopharma ("Byron") under its licensing agreement where CEL-SCI granted Byron an exclusive license to market and distribute the Company's cancer drug Multikine® in the Republic of South Africa (the "Territory"). CEL-SCI already has existing licensing agreements for Multikine with Teva Pharmaceuticals of Israel and Orient Europharma of Taiwan in other countries. CEL-SCI plans to keep the European and US marketing rights for the Multikine head and neck cancer indication in-house.
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Under the agreement, Byron will also be responsible for registering the product in the Territory. Once Multikine has been approved for sale, CEL-SCI will be responsible for manufacturing the product, while Byron will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and Byron.
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"We are pleased that Byron has elected to make this payment to maintain its rights in the Territory," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We are continuing to seek marketing and development partners in other emerging markets, while maintaining rights to key markets, even as we prepare to commence a pivotal Phase III study for Multikine in head and neck cancer. Fortunately we are in a financially strong position allowing us to proceed in this manner." Head and neck cancer is one of the world's biggest cancers affecting about 650,000 people per annum worldwide.
CEL-SCI is developing Multikine for approval as a first-line indication in newly diagnosed head and neck cancer. To that end, the Company's planned Phase III clinical trial is an 800 patient randomized, controlled clinical study designed to demonstrate that administration of its cancer drug Multikine to head and neck cancer patients before they receive any other conventional cancer treatment will increase their overall survival. 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, and has granted CEL-SCI's Multikine an Orphan Drug Designation for the "neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN)". Recently CEL-SCI finished the validation of its dedicated state of the art commercial-ready manufacturing facility for Multikine.
Multikine is 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.
Multikine is a patented defined mixture of naturally derived cytokines. It 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.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
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, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, 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, 2009. 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
