Printer Friendly

CEPHALON INITIATES EUROPEAN PHASE II/III CLINICAL TRIAL OF MYOTROPHIN(TM)

 WEST CHESTER, Pa., Oct. 5 /PRNewswire/ -- Cephalon, Inc. (NASDAQ: CEPH) announced today the initiation of Phase II/III clinical trials of Myotrophin(TM) in amyotrophic lateral sclerosis (ALS) patients in Europe.
 The company said it plans to enroll approximately 150 patients in a double-blind, placebo-controlled trial at major ALS clinics in the United Kingdom, France, Italy, Belgium, Germany and the Netherlands. David Brigden, M.D., Cephalon's medical director, Europe, will manage the eight-center study from the company's office in Guildford, England.
 "The European trial is our second well-controlled pivotal study. These trials will support product approval applications in Europe and if necessary will also support the application for U.S. approval," stated Dr. Franklin Baldino Jr., president and CEO of Cephalon. "Previously reported results from Phase I studies in normal subjects and in ALS patients demonstrated that Myotrophin is safe and well tolerated. The Phase II/III European protocol is consistent with the ongoing U.S. study and involves a three month base line


evaluation followed by a nine month dosing regimen. These studies will evaluate the potential of Myotrophin to treat this insidious disorder, for which there is no effective therapy."
 ALS, also known as Lou Gehrig's disease, is a fatal disorder characterized by the progressive degeneration of motor neurons. It afflicts approximately 25,000-30,000 patients in the United States and 40,000 patients in Western Europe. In most patients 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.
 Myotrophin consists of recombinant human IGF-1 (Insulin-like Growth Factor-1), a naturally occurring protein which mediates the nervous system's normal recovery from injury. Myotrophin has been shown in multiple animal studies to promote the survival of motor neurons and enhance the regeneration of damaged motor nerves. Cephalon began pivotal Phase II/III U.S. clinical trials with Myotrophin in January of this year to treat patients with ALS. In July Cephalon entered into a collaboration with Kyowa Hakko Kogyo Co., Ltd., a Japanese pharmaceutical firm, to develop Myotrophin in Japan.
 Cephalon holds a U.S. patent for the use of Myotrophin in certain neurodegenerative disorders, including ALS, and Myotrophin has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of ALS.
 Cephalon, Inc. is a leader in the discovery and development of products to treat neurological diseases and disorders. The company's principal focus is on neurodegenerative diseases such as ALS, peripheral neuropathy, Alzheimer's disease, head and spinal cord injury, and stroke.
 /delval/
 -0- 10/5/93
 /CONTACT: Lyn Hyduke, corporate communications, of Cephalon, 215-344-0200, or Karen Bergman of Burns McClellan, 212-505-1919, for Cephalon/
 (CEPH)


CO: Cephalon, Inc. ST: Pennsylvania IN: MTC SU:

MJ-CC -- PH001 -- 8694 10/05/93 08:02 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Oct 5, 1993
Words:467
Previous Article:THE NEW QUAKER STATE CEO SETS GOALS FOR STRONGER EARNINGS AND INCREASED MARKET SHARE
Next Article:SAIC WINS MAJOR RAILROAD AEI CONTRACTS
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters