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CytRx Reports Promising Data from Its Open-Label Extension Clinical,Trial of Arimoclomol in ALS

ear with a four-fold arimoclomol dose increase, subject to FDA clearance.

"We are encouraged by the favorable results of this open-label trial, which make us even more eager to proceed at an even higher dose level in further clinical testing," stated CytRx's President and CEO Steven A. Kriegsman. "The comparison of these clinical results with historical data suggests a trend toward clinical improvement. Our Phase IIb efficacy study will be placebo-controlled and is planned to include a larger number of volunteers, treated for a longer period of time with a four-fold higher dose than that used in the open-label clinical trial."

The open-label extension clinical trial was initiated in February 2006 as ALS volunteers completing CytRx's placebo-controlled, double-blind, dose-ranging Phase IIa clinical trial were provided the opportunity to receive arimoclomol treatment for up to an additional six months. A total of 69 patients were treated in the open-label arimoclomol trial for six months, while the historical control followed 99 subjects for 12 months.

In the open-label trial, arimoclomol treatment was demonstrated to be safe as indicated by the lack of clinically-significant changes in vital signs and laboratory values, compared to baseline values. Arimoclomol was also well-tolerated with a total drop-out rate of 11.6%, or an average of 1.3% per month, during the six-month trial. This compares favorably with the historical control drop-out rate of 33.3%, or an average of 2.75% per month, for the 12-month trial.

CytRx's planned Phase IIb clinical trial is currently expected to include approximately 390 ALS patients enrolled at 30 to 35 U.S. and Canadian clinical sites treated for nine months. The trial is expected to be completed approximately 18 months after enrollment begins.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therap
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