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High dose Xyotax to be tested in recurrent and chemo-resistant ovarian cancer

SEATTLE, WASH., Aug 14, 2002 -- Cell Therapeutics announced that the Gynecologic Oncology Group (GOG), a cooperative of many of the most prominent physicians and institutions in the United States, has activated a Phase II study protocol to evaluate the effectiveness of Xyotax in treating patients who have recurrent ovarian cancer, including those who are taxane-resistant.

Some of the institutions involved in this study include Mayo Clinic, Duke University Medical Center, Tufts-New England Medical Center, UCLA, University of Chicago, Walter Reed Army Medical Center, and University of Washington Medical Center.

Paul Sabbatini, M.D. of Memorial Sloan-Kettering Cancer Center, and John Kavanagh, M.D. of The University of Texas M. D. Anderson Cancer Center are co-chairs of this study. Dr. Kavanagh stated, "I am pleased to be involved in this study because M. D. Anderson has been at the forefront in the early research with Xyotax, and I'm impressed with the preclinical, pharmacokinetic (PK), and clinical data."

He further indicated that he is anxious to see Xyotax's effectiveness as a single agent in treating taxane-resistant patients.

This phase II study is designed to enroll 45 patients who have recurrent or resistant disease and have been treated with up to two prior chemotherapeutic regimens. Patients on study will receive single-agent therapy treatment with Xyotax (at 235 mg/m2) dosed every third week and will continue treatment until disease progression. Physicians or patients who might be interested in participating in this trial should contact a local institution affiliated with the GOG.

"We are honored to have the GOG, the cooperative group that establishes treatment practices for gynecologic cancers, leading this study," stated James A. Bianco, M.D., president and CEO of CTI. "Given the encouraging responses and well tolerated side effect profile observed at the 175 mg/m2 dose in salvage ovarian cancer, using a higher dose in less heavily treated patients should yield exciting results."

Xyotax is a first-in-class 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.

Posted: August 2002