FDA lifts its hold on CytRx ALS program

The FDA provided some good news to Los Angeles-based CytRx, lifting its nearly two-year-old clinical hold on an oral drug for Lou Gehrig's disease and fueling a 16 percent spike in its stock price. And the company's CEO flagged the news as a key milestone in its talks with potential partners.

Regulators accepted CytRx's revised clinical trial protocol for arimoclomol, allowing researchers to test the drug in patients at levels up to four times the dose used in a Phase IIa trial. CytRx says that the FDA will allow the drug to be given at 400 milligrams three times a day for patients with Lou Gehrig's disease--or amyotrophic lateral sclerosis--a progressive degenerative disorder. The company believes the drug has solid potential for a range of conditions, including Alzheimer's disease, Parkinson's disease and Huntington's disease.

"We have attracted significant interest from several pharmaceutical companies as potential partners to advance development of our molecular chaperone programs, and we view clearance to resume arimoclomol clinical testing as a key step in moving these negotiations forward," said CEO Steven Kriegsman. "Given the significant opportunity arimoclomol presents in ALS, we are prepared to resume the clinical trial in parallel with our discussions."

- here's the CytRx press release for more info
- check out the Reuters story