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

LOS ANGELES--(BUSINESS WIRE)--Jun 27, 2007 - CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced promising data from the six-month, open-label extension of its completed Phase IIa clinical trial with arimoclomol in ALS volunteers. While the clinical trial was not placebo-controlled, arimoclomol at a 100 mg dose three times daily appeared to be safe and well-tolerated throughout the six-month period. Further, the rate of decline of several key disease symptom indicators, including the Revised ALS Functional Rating Scale (ALSFRS-R), which measures overall functional capacity, and vital capacity, which measures breathing ability, in the arimoclomol-treated group compared favorably to a matched historical control.

Several markers of disease progression were followed throughout the open-label extension clinical trial, including the ALSFRS-R, vital capacity, total body weight and body mass index (a measure of obesity). In the absence of placebo control, CytRx chose to compare the open-label clinical trial results with the placebo group of a recently-published clinical trial (Cudkowicz, M.E., et. al., Annals of Neurology 2006 volume 60:22-31) that enrolled patients with very similar characteristics. While difficult to draw definitive conclusions without a concurrent placebo control group, there was an apparent trend toward a slower decline in every disease progression marker in the arimoclomol open-label clinical trial compared with the historical placebo control. In the trial, CytRx observed a decrease in the rate of decline of 21% for ALSFRS-R, 8.0% for vital capacity, 23% for total body weight and 20% for body mass index when compared with that historical control.

Based on safety data from a previously announced rising multiple dose clinical trial, CytRx plans to commence its Phase IIb clinical trial later this y
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