CytRx Receives FDA Correspondence Regarding Phase IIb Arimoclomol Clinical Trial In ALS

Main Category: Muscular Dystrophy / ALS
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 13 Feb 2008 - 2:00 PDT

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CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, announced receipt of a written correspondence from the U.S. Food and Drug Administration (FDA) providing clarification on the FDA's decision to place on clinical hold the Company's Phase IIb trial with arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

The correspondence confirmed CytRx's previously announced understanding that the FDA's decision pertained to a previously completed animal toxicology study in rats and was not related to data generated from any human studies with arimoclomol.

"We now have clarity on the FDA's decision and are actively analyzing data from the previously completed toxicology study to prepare a response that addresses the issues cited by the FDA. Following further analysis and after discussion with the FDA, we will assess the need, if any, to conduct additional toxicology studies before or concurrently with the resumption of our Phase IIb clinical trial, and determine what those studies, if any, would entail," said CytRx's President and CEO Steven A. Kriegsman. "As previously stated, we will take the necessary steps to resolve this matter as expeditiously as possible, and we plan to work with the FDA to address their questions and allow us to move forward with our Phase IIb trial."

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's Phase IIb clinical trial with arimoclomol for ALS was placed on clinical hold by the FDA in January 2008. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted 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 second 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 http://www.cytrx.com.

About RXi Pharmaceuticals Corporation

Worcester, Massachusetts-based RXi Pharmaceuticals Corporation, a majority-owned subsidiary of CytRx, is a discovery-stage biopharmaceutical company pursuing the development and potential commercialization of proprietary therapeutics based on RNA interference (RNAi) for the treatment of human diseases. RXi Pharmaceuticals' rxRNA™ compounds are distinct from the classic siRNA compounds used by other companies developing RNAi therapeutics, are up to 100-times more active than conventional siRNA (depending on the target site), are nuclease resistant and are readily manufactured. RXi Pharmaceuticals believes it is well positioned to compete successfully in the RNAi-based therapeutics market with its accomplished scientific advisors, including Dr. Craig Mello, recipient of the 2006 Nobel Prize for his co-discovery of RNAi, a management team that is experienced in commercializing products, and a strong early intellectual property position.

Forward-Looking Statements

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 related to the impact of the clinical hold on the timing and ability to resume and continue the Phase IIb clinical trial, as well as other 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.

CytRx Corporation