CytRx Submits Response To FDA Related To Clinical Program With Arimoclomol In ALS

Main Category: Muscular Dystrophy / ALS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Mar 2008 - 1:00 PDT

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CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, announced that it has filed a response with the U.S. Food and Drug Administration (FDA) addressing issues cited by the FDA in its decision to place a clinical hold on the Company's Phase IIb clinical trial with arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

On February 11, 2008, CytRx announced receipt of written correspondence from the FDA. This correspondence confirmed the Company's prior understanding that the FDA's decision to place the Phase IIb program on clinical hold pertained to a previously completed toxicology study in rats and was not related to data generated from any human studies with arimoclomol.

"Following additional analysis of the prior toxicology study, we have submitted a response to address the concerns cited in the FDA's written correspondence," said CytRx's President and CEO Steven A. Kriegsman. "We will continue working with the FDA to determine as expeditiously as possible the need, if any, to conduct additional toxicology or other studies before or concurrently with the resumption of our Phase IIb clinical trial, or to modify the protocol for this trial. We will provide a further update when all issues pertaining to our planned resumption of our Phase IIb clinical trial have been resolved."

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 second 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.

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 at the desired dosage of arimoclomol, the risk that any requirements imposed on the clinical trial design by the FDA might adversely affect our ability to demonstrate that arimoclomol is efficacious in treating the patients in the trial or cause us to cancel the trial due to one or more of these considerations, the potential need to conduct additional toxicology or human studies which could result in substantial additional expenses and delay the resumption of the 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

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