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Pivotal Registration Trial of OPAXIO Maintenance Therapy in First-Line Ovarian Cancer Reaches Enrollment Milestone of 600 patients, Cell Therapeutics and the Gynecologic Oncology Group Discuss Potential for Early Interim Analysis
Date:9/21/2009

ation pathway for OPAXIO."

"We believe focusing on ovarian maintenance, and radiosensitization, not only address areas of unmet medical need, but are in the best long term strategic interest of CTI. With the FDA review of the NDA for pixantrone in relapsed/refractory non-Hodgkin's lymphoma well underway and the phase III Ovarian trial of OPAXIO progressing nicely we are pleased with the advancement and future potential of these novel treatments," said James A. Bianco, M.D., CEO of CTI.

CTI has an existing license and co-development agreement with Novartis for OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.

About OPAXIO

OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncol
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SOURCE Cell Therapeutics, Inc.
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