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Drug Fails To Help People With Lou Gehrig's Disease

Posted by Chrissie Cole
Wednesday, November 26, 2008 12:13 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, IGF-1, Lou Gehrig's Disease, ALS, Myotrophin, Cephalon Inc., Growth Hormone


IMAGE SOURCE: © Wikimedia Commons/ structure of Insulin-like growth factor-1 / author: DanielleDk

A growth hormone that had previously shown some promise for treating people with amyotrophic lateral sclerosis (ALS), often called Lou Gehrig's disease, showed no benefit in a new study published in the November issue of the journal Neurology.

Two earlier, shorter studies produced inconsistent results. A North American study found IGF-1 beneficial, while a European study found no benefit for people with ALS.

The current study included 330 patients from 20 medical centers throughout the U.S. over the duration of two-years. It was designed to be the definitive test of Myotrophin, an experimental insulin-like growth factor-1, or IGF-1, by Cephalon Inc.

ALS is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscles. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons.

An estimated 5,600 people in the United States are diagnosed with ALS every year. ALS is responsible for nearly two deaths per hundred thousand annually.

For the study, patients were put in two groups – one group was given IGF-1 injections while the other group was given a placebo. The patients’ muscle strength was tested when the study started and five times over the two-year period.

Researchers found that IGF-1 does not slow the progression of muscle weakness. "We found that the drug doesn't work," study author Dr. Eric J. Sorenson of the Mayo Clinic, said in a news release.

“We are disappointed that we were unable to confirm the benefits that were seen in the North American study. We need more effective ALS treatments,” said Sorenson.

Several companies have tried to develop new drugs for ALS, but nearly a decade later there is only one FDA-approved drug available for these patients.

“At this time we have no further studies of Myotrophin planned and no other drugs in development for ALS,” a Cephalon company spokeswoman said via e-mail. #

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