From ALS Association
June 16, 2003

After some delay, the Phase III multi-center clinical trial of Insulin-like growth factor (IGF-1), Myotrophin? is about to start. Patient enrollment begins this month at five of the study sites. These sites include the certified ALSA Centers at the Mayo Clinic in Rochester, Minn., the Mayo Clinic in Scottsdale, Ariz. and at the Hennepin Faculty Associates in Minneapolis, Minn. Other sites to begin enrollment this month are the University of Cincinnati and the Mayo Clinic in
Jacksonville, Fla.

The certified ALSA Center at the University of Michigan, Ann Arbor, Mich., and the Henry Ford Hospital in Detroit, Mich. are finalizing plans to begin accepting patients into the study later this summer. Also planning to begin enrollment this summer is the Medical College of Wisconsin in Milwaukee, WI.

Other sites will be ready to enroll patients into this study once staff training has been completed later this year. ALSA?s web site includes a full listing of all of the Myotrophin? study sites and the contact information for each site at http://www.alsa.org/news/news012302_2.cfm. For information about enrolling in this study, please contact the study sites.

The objective of this trial is to determine whether IGF-1 (Myotrophin?) slows the progression of weakness in amyotrophic lateral sclerosis (ALS). Three hundred patients with ALS from multiple medical centers will participate in this double blind, placebo-controlled two-year study.

If conclusive, the results of this study will be an important factor in a decision to approve this medication for general use in ALS. The National Institute of Neurological Disorders and Stroke (NINDS) and The ALS Association (ALSA) are funding the study.

Previous clinical trials of IGF-1 in ALS patients in the U.S. and in Europe have led to conflicting conclusions (positive results in U.S. and negative results in Europe), most likely due to differences in study design. In these clinical trials there were no significant drug-related adverse events, other than mild injection site irritation. Continued laboratory work with IGF-1 and strong patient and family interest have led to this new clinical trial.

For further information about the IGF-1 trial, including answers to frequently asked questions (FAQs) and a list of the study sites, see ALSA?s web site at http://www.alsa.org/news/news012302.cfm#SUMMARY and contact one of the individual study sites or call The ALS Association at (800) 782-4747.