CytRx Receives FDA Letter Regarding Arimoclomol Phase IIb Clinical Trial for ALS

"We are delighted with the FDA's letter, which we believe opens a viable pathway for continued development of arimoclomol for ALS and represents a significant step in its advancement as a potential treatment for this debilitating disease," said CytRx's President and CEO Steven A. Kriegsman. "We are addressing the FDA's letter by formulating a Phase IIb clinical trial protocol that will, among other modifications, include escalating dosing of orally administered arimoclomol up to the 400 milligrams, three times daily as originally planned in the previous protocol. As expected, the FDA letter did not indicate a need for additional animal toxicology studies or other studies prior to the revised protocol submission.

"We expect this positive development to support our pursuit of strategic alternatives, including potential partnerships, for the further development of arimoclomol. We are also continuing to evaluate possible clinical development of arimoclomol for stroke recovery and neuropathy, which were not directly affected by the FDA's prior letter relating to the Phase IIb clinical trial for ALS. Those two major therapeutic markets present additional opportunities for CytRx to create significant value for our stockholders." he added.

Arimoclomol is a molecular chaperone regulator drug candidate that is being considered as a treatment for ALS, stroke recovery and other diseases. Molecular chaperone regulator drugs are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of "molecular chaperones." Molecular chaperones detect proteins that are misfolded, and have the ability to refold those proteins into the appropriate, non-toxic shape.

About ALS

ALS is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement. ALS is a common neuromuscular disease, affecting an estimated 120,000 people of all races and ethnic backgrounds worldwide. Over a period of months or years, ALS causes increasing muscle weakness, inability to control movement and problems with speaking, swallowing and breathing. According to the ALS Association more than 5,600 people in the U.S. are diagnosed with ALS annually and an estimated 30,000 Americans have ALS at any given time. According to the National Institute of Neurological Disorders and Stroke, most ALS patients die within three to five years after the onset of symptoms.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 39% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit www.cytrx.com.

Forward-Looking Statements

This press release contains 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 the risk that CytRx will be unable to secure a partnership to fund any further development of arimoclomol for ALS, including any Phase IIb clinical trial, uncertainties related the timing and ability to resume that clinical testing at the desired dosage of arimoclomol, the risk that the requirements imposed on the Company's planned clinical trial designs for ALS by the FDA as expressed in its recent written correspondence might adversely affect or delay the Company's ability ultimately to demonstrate that arimoclomol is efficacious in treating ALS, increase the cost of clinical development, adversely affect the Company's ability to enter into a partnership related to the future development of arimoclomol for ALS or any other indication, or cause the cancellation of the trial altogether, risks relating to the timing, outcome or results of future clinical testing of arimoclomol, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. 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.

SOURCE: CytRx Corporation

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