=============================================================== == == == ----------- ALS INTEREST GROUP ----------- == == ALS Digest (#41, 03 MAY 1993) == == == == To subscribe, to unsubscribe, to request back issues, == == to contribute notes, etc. to ALS Digest, please send == == e-mail to: == == bro@huey.met.fsu.edu (Bob Broedel) == == == == All interested people may "broadcast" messages to == == ALS Digest subscribers by sending to: == == als@huey.met.fsu.edu == == == == The month of May has been designated by the US Congress == == as: /// NATIONAL ALS AWARENESS MONTH /// == =============================================================== (1) ===== re: myotrophin ========== The following was collected via the Executive News Service on Compuserve. ----- OTC 05/03 1023 CEPHALON, INC. PRESENTS DATA ON MYOTROPHIN IN ALS. WEST CHESTER, PA (BizWire) Cephalon, Inc. (NASDAQ: CEPH) announced at the Annual Meeting of the International Spinal Muscle Atrophy (SMA) Consortium results of preclinical and clinical studies for the treatment of neurodegenerative diseases using the Company's proprietary compound, Myotrophin(TM), a recombinant human form of insulin-like growth factor-1 (IGF-1). IGF-1 is a naturally occurring protein which mediates the nervous system's normal attempt to recover from injury. As reported by Dr. Stanley H. Appel, Chairman of the Department of Neurology at The Baylor College of Medicine, Phase I human clinical trials of Myotrophin have demonstrated that subcutaneous administration of this compound to either normal individuals or Amyotrophic Lateral Sclerosis (ALS) patients results in a significant, prolonged elevation of IGF-1 levels in serum, with no significant side effects. Serum concentrations achieved in the Phase I studies were similar to those obtained for preclinical studies which found that Myotrophin enhanced regeneration and sprouting of motor neurons in muscle tissue. In addition, Michael E. Lewis, Ph.D., Cephalon's Senior Director of Scientific Affairs, presented preclinical data demonstrating that Myotrophin can prevent peripheral nerve damage (neuropathy) caused by administration of the new anti-tumor drug, taxol. "Taxol is an important new chemotherapeutic agent that is gaining broad-based utility in the treatment of many forms of cancer," stated Dr. Frank Baldino, Jr., President and CEO of Cephalon. "The use of Myotrophin as an adjunctive agent in taxol therapy presents an important market opportunity for the company." Earlier this year the Company presented data that Myotrophin prevented the development of neuropathy induced by the anti-cancer agent vincristine in reliable animal models of neuropathy. Coupled with today's announced data with taxol these data suggest that Myotrophin may be broadly applied in the treatment of neuropathies induced by several chemotherapeutic agents. In January 1993, Cephalon initiated Phase II/III clinical trials of Myotrophin in ALS patients. Approximately 200 patients will be enrolled into a double-blind, placebo-controlled trial at major ALS clinics across the United States and Canada, including The Baylor College of Medicine in Houston, The Columbia University-Presbyterian Hospital in New York City, The ALS & Neuromuscular Research Foundation in San Francisco and The Clinical Research Foundation in Lenexa, Kansas. Characterized by the progressive degeneration of motor neurons, ALS, also known as Lou Gehrig's disease, is a fatal disorder affecting approximately 25,000-30,000 patients in the U.S. The disease progresses over a three to five year period, with death typically occurring due to loss of respiratory muscle control rendering the patient unable to breathe. Currently, there is no effective therapy for this devastating disease. Peripheral neuropathy is a collection of disorders of the peripheral nervous system (PNS) characterized by a degeneration of peripheral sensory and motor nerves. The disability produced by any particular neuropathy depends on the nerves affected. Sensory neuropathies are accompanied by burning sensations, imbalance and both numbness and pain. Motor neuropathies are characterized by muscular weakness and motor abnormalities, including problems with coordination, movement and respiration. In the most severe cases, peripheral neuropathy may eventually lead to significant limitations in normal physical activity. The peripheral neuropathy that Cephalon first plans to focus on is chemotherapy-induced neuropathy, particularly that resulting as a side effect of treatment with vincristine, taxol and cisplatin. Cephalon, Inc. discovers and develops pharmaceutical products for the treatment of neurological diseases and disorders. The Company's primary focus is on neurodegenerative diseases, which are characterized by the death of neurons, the specialized conducting cells of the nervous system. The Company has concentrated its research programs on the prevention of neuronal death in several disorders, including ALS and peripheral neuropathy, Alzheimer's disease, head and spinal cord injury and stroke. CONTACT: Cephalon Inc., West Chester Lyn Hyduke, 215/344-0200 or Burns McClellan Karen L. Bergman, 212/505-1919 == end of als 41 ==