* Says FDA accepts revised clinical trial protocol
* Says trial to include safety and efficacy evaluation
* Shares up as much as 16 pct
Dec 2 (Reuters) - CytRx Corp CYTR.O said U.S. health regulators lifted a clinical hold on its experimental oral drug for the treatment of Lou Gehrig’s disease after accepting the company’s revised trial protocol, sending its shares up as much as 16 percent.
The biopharmaceutical company said the revised protocol will assess safety and efficacy in patients treated with the drug candidate, arimoclomol, at levels up to four times the dose administered in previous studies.
The maximum dose in the protocol allows for testing arimoclomol at 400 milligrams three times daily, the company said in a statement.
The drug was placed on clinical hold by the U.S. Food and Drug Administration in January 2008.
Arimoclomol has fast track designation and orphan drug status for the treatment of Lou Gehrig’s disease or amyotrophic lateral sclerosis — a degenerative disease that results in muscle weakness, inability to control movement, problems with speaking, swallowing and breathing.
Shares of CytRx were up 13 percent at $1.13 on Nasdaq. They earlier touched a high of $1.16. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Aradhana Aravindan) ((email@example.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800: Reuters Messaging: firstname.lastname@example.org))