Cell Therapeutics says Xyotax has future
Tue Feb 21, 2006 5:09 PM ET
By Deena Beasley
LOS ANGELES, Feb 21 (Reuters) - Cell Therapeutics Inc. (CTIC.O: Quote, Profile, Research), 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.
"Our goal is to take data from interim analysis and feed it into the new drug application in the fourth quarter of this year, which will be based on observations made in the two (earlier late-stage) studies," 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.
If the company has to wait until the latest trial is complete, the regulatory filing would happen in 2008, Bianco said.
Xyotax links the chemotherapy drug paclitaxel to a substance that binds to tumors, with the goal of reducing damage to healthy cells as well as side effects like nausea and hair loss.
The drug is believed to work better in women because enzymes regulated by the hormone estrogen break down the protein binding, enhancing effectiveness of the treatment.
"The data in women deserves its day in front of the FDA," Bianco said.
He said a few multinational pharmaceutical companies have been particularly interested in the drug's gender-specific effect and the company hopes to sign up a commercial partner.
In order to do that, Cell Therapeutics would like to regain rights to the drug in Japan and other Asian countries that are now held by Chugai Pharmaceutical Co. Ltd. (4519.T: Quote, Profile, Research).
Such an announcement is likely "within the next few weeks," Bianco said.
(Additional reporting by Julie Steenhuysen)
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