LOS ANGELES--CytRx Corporation a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that Merit Cudkowicz, M.D. and Jeremy Shefner, M.D. will be presenting previously-released data from the Company's Phase IIa trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at the 17th International Symposium on ALS/MND being held November 30 through December 2, 2006 in Yokohama, Japan. Drs. Cudkowicz and Shefner are co-principal study investigators of the trial.
A poster presentation titled "A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS" will be available on Thursday, November 30, and on Saturday, December 2. Dr. Cudkowicz will deliver a 15-minute closing slide presentation on the same topic beginning at 2:15 p.m. local time.
In September 2006, CytRx announced that primary endpoints were met in its Phase IIa double-blind, placebo-controlled, clinical trial of the safety and tolerability of arimoclomol compared with placebo over 12 weeks of treatment in patients with ALS. Initial Phase IIa data suggests the achievement of a secondary endpoint that includes drug absorption, distribution and elimination. Subject to U.S. Food and Drug Administration (FDA) approval, CytRx plans to initiate a Phase IIb clinical trial with arimoclomol for the treatment of ALS in the 3rd quarter of 2007.
Arimoclomol is one of CytRx's three orally-administered, small molecule compounds. This small molecule drug candidate is believed to function by stimulating a normal cellular protein repair pathway through the activation of "molecular chaperones." Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases. This is a normal biological process used for clearing dead cells, wounds, etc.
The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS.
Nasdaq:CYTR is trading at $1.68, down 3 cents or 1.7% this morning.
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