CytRx Reports Favorable Safety and Tolerability Results from High Dose, 28-Day Clinical Trial with Arimoclomol
CytRx believes that results from this clinical trial, together with previously-announced clinical data from a rising multiple dose study reported in June 2007, support the use of arimoclomol in future clinical trials, including its planned ALS Phase IIb efficacy trial, at a dose four-fold higher than administered in its prior Phase IIa and open label extension clinical trials for ALS.
"This clinical trial builds on results of our previously-announced short-term rising multiple dose study by demonstrating that arimoclomol is equally as safe and well tolerated at 400 mg administered three times daily in a larger number of volunteers treated over a longer time duration," said CytRx's President and CEO Steven A. Kriegsman. "We now have additional clinical support for our decision to administer arimoclomol at this higher dose in our upcoming ALS and stroke recovery clinical trials. We continue on track to initiate our Phase IIb efficacy trial in ALS, subject to U.S. Food and Drug Administration (FDA) clearance, before the end of this year."
Of the 16 healthy volunteers enrolled in the double-blind, placebo-controlled trial, 12 were administered 400 mg arimoclomol capsules three times daily for 28 days, and four received placebo. Study data demonstrated no differences between arimoclomol and placebo in any of the safety measures, which included general urine and blood chemistries, renal and liver function, electrocardiogram (ECG), vital signs and physical examination. The most common reported adverse events were related to gastrointestinal irritation and were only slightly more frequent in the arimoclomol-treated subjects as compared to placebo-treated subjects (33% vs. 25%). The study further demonstrated that the way that the body controls arimoclomol levels in the blood, called pharmacokinetics, did not change over the 28-day period of arimoclomol dosing.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to FDA clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been orphan medicinal product status for the treatment of ALS from the European Medicines Agency. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.
About RXi Pharmaceuticals Corporation
Worcester, Massachusetts-based RXi Pharmaceuticals Corporation, a majority-owned subsidiary of CytRx, is a biopharmaceutical research and development company that focuses on developing RNAi-based therapeutics for the treatment of human disease. RXi's initial focus is on neurodegenerative diseases, oncology, type 2 diabetes and obesity. RXi has licenses to a diverse series of early patents and patent applications that were filed from 1998 to 2006 in the areas of RNAi target sequences, RNAi chemistry and RNAi delivery. The Company was founded by CytRx and RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for discovering RNAi and inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of RNAi mechanism (RISC) and short hairpin RNAi (shRNAi); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH(TM) RNAi, one of the most widely used second-generation RNAi research products.
This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K and any current reports on Form 8-K filed since the date of the last Form 10-K. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Dan Schustack, 212-732-4300
Posted: November 2007