Arimoclomol Significantly Inhibits Progression of Amyotrophic Lateral Sclerosis
Apr 20, 2005 - 9:23:38 AM
CytRx Corporation (Nasdaq: CYTR - News) today announced the completion of a meeting with representatives of the U.S. Food and Drug Administration (FDA) prior to the submission of the Company's Investigational New Drug (IND) application for its lead small molecule drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). The FDA's pre-IND meeting programs are designed to provide sponsors with advance guidance and input on drug development programs.
Jack Barber, Ph.D., CytRx's Senior Vice President, Drug Development, stated, "The purpose of our meeting was to seek guidance from the FDA concerning the upcoming submission of our IND application for arimoclomol. We plan to file an IND application with the FDA and expect to begin a Phase II clinical trial for the treatment of ALS in the current quarter."
Arimoclomol provides cellular protection from abnormal proteins by activating molecular "chaperone" proteins that can repair or degrade the damaged proteins that are believed to cause many diseases, including ALS.
Arimoclomol was previously shown to be well tolerated in two Phase I clinical trials in healthy volunteers. Originally developed to treat diabetic complications, arimoclomol was recently discovered to significantly inhibit progression of ALS in an experimental animal model of the disease (Kierin et al., Nature Medicine, April 2004, Vol. 10(4), 402-5).
According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% of ALS patients die within five years of diagnosis. Approximately 30,000 people are living with ALS and nearly 6,000 new cases are diagnosed each year in the U.S. alone, according to the ALS Association. There are over 120,000 people living with ALS worldwide.
CytRx Corporation makes no representation that the FDA will allow any clinical trial to take place upon the filing of the IND, or take any other action to allow arimoclomol to be studied or marketed.
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