Cell Therapeutics says Xyotax has future

By Deena Beasley

LOS ANGELES (Reuters) - Cell Therapeutics Inc. (CTIC.O: Quote, Profile, Research, Stock Buzz), whose experimental lung cancer drug Xyotax failed in two key clinical trials, still sees promise for the drug and expects to file for U.S. regulatory approval in the fourth quarter of this year, the company's chief executive said on Tuesday.

While Cell Therapeutics failed to show that Xyotax was superior to standard chemotherapy, the company did find a survival benefit in women taking the drug and has launched a separate trial to test its effectiveness.

CEO James Bianco said at the Reuters Biotechnology Summit in Los Angeles that the company will begin submitting Xyotax data to the U.S. Food and Drug Administration in the fourth quarter of this year and hopes to have a decision from the agency by the second quarter of next year, based on the previous studies and interim results from the latest trial focused on women.

"This will be a good test case, if you will, to see how the FDA looks at the data, even though it is retrospective," Bianco said.

The CEO said the company expects to meet with high-level FDA officials in the second quarter of this year to finalize the filing strategy.

Under the best-case scenario, Cell Therapeutics would be able to launch Xyotax in the fourth quarter of 2007, he said.

"The bar is still pretty high in oncology. Non-inferiority to chemotherapy is not what moves the field forward. They are looking for the next big advance in therapy," Bianco said.

But despite recent advances in targeted therapies for cancer, traditional chemotherapy drugs are likely to be around for years to come, he noted.  Continued...