London,UK April 24, 2013 – Ergomed Clinical Research Ltd. ("Ergomed") today announced the signing of a co-development and revenue sharing agreement with CEL-SCI Corporation (NYSE MKT: CVM) for Multikine in head and neck cancer. Under the agreement Ergomed will work with CEL-SCI conducting a multicenter, multinational, randomized Phase 3 trial with Multikine in head and neck cancer.
Ergomed will share the costs of the clinical and regulatory costs in Europe, Russia and India for the Phase 3 trial, which are estimated at approximately $30 million over the course of the study. Ergomed will receive its return on investment based as a single digit percentage of milestone and royalty payments generated by CEL-SCI from Multikine, up to a specified maximum amount, from head and neck cancer sales of Multikine. Ergomed's unique site management model will be utilised on the study to enhance patient recruitment.
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted to co-invest with CEL-SCI in the development of Multikine. This agreement is the sixth co-development deal we have signed to date, and demonstrates again the attractive alternative it offers to sophisticated drug developers as they look to maximise investment returns. Ergomed is now established as one of the leading companies worldwide offering and completing deals under this innovative model. We are looking to expand our unique codevelopment business building on our 15 year experience in drug development".
Geert Kersten, CEL-SCI's CEO added: "Ergomed's co-development agreement is important since Ergomed is responsible for most of the patient enrollment and patient enrollment is the rate limiting step in the study. We believe that the co-development model aligns their interests with those of CEL-SCI, leading to fast enrollment and completion of the study. We are looking forward to working with Ergomed on the study."
The Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.
CEL-SCI's lead investigational therapy Multikine, is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.
About Ergomed
Ergomed offers clinical development services for the biotechnology and pharmaceutical industry specializing in therapeutics for oncology, neurology and immunology. Ergomed also engages in shared risk ventures through co-development agreements. With its global infrastructure in Western and Eastern Europe, the Middle East and North America., Ergomed offers cost effective and efficient drug development. For further information visit www.ergomed-cro.com.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy 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 possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu.