VIENNA, Va., March 9 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Alternext US: CVM) announced today that it has entered into an exclusive licensing agreement with Byron Biopharma ("Byron") under which CEL-SCI has 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 and Orient Europharma.
Pursuant to the agreement, Byron will purchase $750,000 worth of stock from CEL-SCI and will make a payment of $125,000 in 12 months. Byron 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 Byron will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and Byron.
"This agreement is consistent with our strategy to license Multikine in the emerging markets to share the expenses of bringing Multikine to market," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We are working on additional agreements around the world."
CEL-SCI is developing Multikine for approval as a first line indication in head and neck cancer. To that end, the Company's planned 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.
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 and recently CEL-SCI took delivery of its new state of the art manufacturing facility.
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. www.cel-sci.com.