Wednesday, March 10, 2010 11:03:36 AM
Thanks.
Did not see this yesterday:
CEL-SCI ANNOUNCES EXCLUSIVE LICENSING AGREEMENT FOR CANCER DRUG MULTIKINE® FOR REPUBLIC OF SOUTH AFRICA
Vienna, VA, March 9, 2009 – 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.
Recent CVM News
- CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation • Business Wire • 09/16/2024 11:30:00 AM
- CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress • Business Wire • 09/10/2024 01:32:00 PM
- The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance • Business Wire • 09/04/2024 01:00:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/30/2024 08:32:13 PM
- CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial Results • Business Wire • 08/15/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:27:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:16:11 PM
- CEL-SCI Announces Closing of $10.8 Million Offering • Business Wire • 07/29/2024 08:05:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/29/2024 11:00:58 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/26/2024 09:27:40 PM
- CEL-SCI Announces Pricing of $10.8 Million Offering • Business Wire • 07/26/2024 03:52:00 PM
- CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results • Business Wire • 07/26/2024 12:23:00 PM
- CEL-SCI Appoints Robert Watson as Chairperson of the Board • Business Wire • 07/08/2024 01:15:00 PM
- CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population • Business Wire • 06/18/2024 12:00:00 PM
- Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor • Business Wire • 06/06/2024 11:00:00 AM
- CEL-SCI Corporation Reports Second Quarter Fiscal 2024 Financial Results • Business Wire • 05/16/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:17:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 01:04:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 05:07:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 01:19:04 PM
- CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer • Business Wire • 05/08/2024 01:00:00 PM
- CEL-SCI Appoints Mario Gobbo to Its Board of Directors • Business Wire • 04/23/2024 01:00:00 PM
- CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology • Business Wire • 03/19/2024 01:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 04:33:13 PM
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