Cell Therapeutics Inc. (NYSE : CTIC) announced on Wednesday that its cancer drug Xyotax qualified for fast track designation for the treatment of poor performance status women.
The Seattle-based firm said that its drug, a modified version of cancer drug Taxol, will launch a phase III trial of its drug with 300 poor performance status woman who have advanced stage non-small cell lung cancer pending FDA approval.
The firm also asked the FDA to begin study of Xyotax in combination with other treatments.
Pending FDA feedback, we anticipate that one or both of these trials would begin enrollment in the second quarter of 2007 with a targeted interim analysis in the first half of 2008, ames A. Bianco, M.D., President and CEO of CTI.
Fast track designation was granted because women in this group are incurable with available therapy, the firm said, and Xyotax has the potential to demonstrate improvement.
Shares of the firm rallied in mid-Wednesday trading, gaining 23 cents, or 14.20 percent to $1.85 in afternoon trading on the New York Stock Exchange.