Cell Therapeutics Inc. began a Phase III trial of Xyotax in non-small-cell lung cancer patients at 20 centers in the U.S., the second Phase III trial in three separate indications the company plans to have under way this year.

The Stellar-2 Trial is expected to enroll 840 patients at more than 100 international sites. It's an open-label, randomized study and is designed to evaluate whether Xyotax is superior to docetaxel in patient survival times. It will investigate 210 mg/m2 of Xyotax against 75 mg/m2 of docetaxel, each dosed every three weeks.

The Seattle-based company initiated an ovarian cancer Phase III trial in July, and said at the time the non-small-cell cancer study shouldn't be far behind. But the third trial the company plans to initiate could be the one that generates a regulatory filing first. (See BioWorld Today, July 31, 2002.)

"The study we are anticipating initializing in the near future is high risk or front line," said James Bianco, president and CEO of Cell Therapeutics.

Xyotax links paclitaxel, the active ingredient in Taxol (marketed by Bristol-Myers Squibb Co., of New York) to a biodegradable polyglutamate polymer. The structure is designed to deliver higher levels of active chemotherapeutics to tumors. Lung and ovarian cancer account for a large portion of taxane sales, Bianco said, and there is reason to believe Xyotax will "migrate to breast and head and neck cancers."

The ovarian trial begun in July is "going well," Bianco said, with 25 or 30 sites enrolling patients at this point. There is a chance an independent GYN-oncology group will run a Phase III trial in ovarian cancer, but it would be run under the group's protocol and investigational new drug application. The group would be able to enroll patients much faster, and Cell Therapeutics might be able to use the data for its own filing, in which case it might "wind down" the ovarian study ongoing now.

Cell Therapeutics said last month that, based on Phase II results in high-risk lung cancer patients, a panel of lung cancer specialists recommended Phase III work evaluating Xyotax in PS 2, or high-risk, patients. The protocol for any test is still under assessment by the FDA, but since high-risk patients, unfortunately, tend to do poorly, the trials are shorter and have less follow-up time, meaning that indication could churn out meaningful data the quickest.

"We'll have a decision within the next couple of months," Bianco told BioWorld Today.

Speaking from New York, where Cell Therapeutics presented to a "packed house" - even at 8 a.m. - at the UBS Warburg Global Life Sciences conference, Bianco said Cell Therapeutics had "a good quarter for Trisenox," its product approved to treat acute promyelocytic leukemia patients whose disease has recurred after initial therapy.

While the company won't release third-quarter figures until Oct. 24, Trisenox brought Cell Therapeutics $2.4 million in net product sales in the second quarter. Bianco said the company is sticking to its estimate of $12 million in Trisenox sales in 2002 and $24 million in 2003. The company had $195.9 in cash, cash equivalents, securities available for sale and interest receivable as of June 30.

Using the sales force it has in place for Trisenox, Cell Therapeutics plans to market Xyotax itself in the U.S. The drug is partnered with Chugai Pharmaceutical Co. Ltd., of Tokyo, for the Japanese market. The company is in discussions for a partner in Europe. But as Xyotax's pivotal trials grow, so does its potential. (See BioWorld Today, Oct. 23, 2001.)

"We think that it can be a very commercially attractive opportunity," Bianco said.

Cell Therapeutics' stock (NASDAQ:CTIC) rose 8 cents Monday to close at $4.60.