Cell Therapeutics, Inc. (CTI) has initiated its Xyotax phase III non-small cell lung cancer trial at 20 centers in the US and anticipates having more than 100 centers initiated by the end of 2002. Called the Stellar-2 Trial, this multi-national pivotal trial is one of three phase III trials targeting lung cancer the Company anticipates initiating this year.

Xyotax (pronounced Zi-o-taks) is a first-in-class smart pharmaceutical that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer. This polymer technology results in a new chemical entity, designed to selectively deliver higher and potentially more effective levels of active chemotherapeutics to tumors. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that Xyotax is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Because more of the chemotherapy is targeted to the tumor and the levels of chemotherapy delivered to normal tissue are reduced, Xyotax may be potentially more effective and have less severe side effects than currently available chemotherapeutics.

"Preliminary phase II data indicate that Xyotax is easier to administer and less toxic to patients than the standard treatment, docetaxel," stated Philip D. Bonomi, M.D., director of medical oncology, Rush-Presbyterian-St. Luke's Medical Center and principal investigator on the study. "This trial is designed to evaluate whether Xyotax improves survival with fewer side effects than docetaxel."

"We have been impressed with how diligently the FDA has worked with its ODAC (Oncology Drug Advisory Committee) consultants and the Company to provide guidance on the study design and endpoints," stated James A. Bianco, M.D., president and CEO of CTI. "Preclinical and preliminary clinical data generated in lung cancer studies suggest Xyotax may not only have less severe side effects than currently marketed taxanes, but it may be more effective."

The American Cancer Society recorded more than 169,000 new cases of lung cancer in the United States last year and lung cancer deaths in 2002 accounted for 28 per cent of all cancer-related deaths in the United States. Eighty percent of lung cancer cases are non-small cell according to the American Lung Association.

The phase III clinical trial of Xyotax will be conducted among patients with non-small cell lung cancer who have relapsed following a single platinum containing front-line treatment. This multi-national (randomized open-label) study is designed to evaluate whether Xyotax therapy results in superior survival when compared to docetaxel, the currently approved treatment. CTI will evaluate the effectiveness of Xyotax (at 210 mg/m2) compared to docetaxel (at 75 mg/m2) dosed every three weeks.