Cell Therapeutics, Inc. (CTI) Announces XYOTAX(TM) Has Fast Track Designation For Women With Advanced Lung Cancer Who Are Performance Status 2 (PS2)

Main Category: Lung Cancer
Also Included In: Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 12 Apr 2007 - 0:00 PDT

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Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced today that XYOTAX, a novel biologically- enhanced version of one of the most used cancer drugs, Taxol(R), qualifies for fast track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC). The Company recently filed a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA) for the design of its phase III trial of XYOTAX for women with advanced NSCLC. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where XYOTAX demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 poor performance status (PS2) women who have advanced stage non- small cell lung cancer (NSCLC) and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of pre-menopausal age or hormone replacement therapy will be randomized in the trial.

Fast track designation was initially granted on June 11, 2003 for XYOTAX for NSCLC PS2 patients (male and female). Confirmation from the FDA was obtained on January 24, 2006 that the existing fast track designation encompasses the treatment of female patients with advanced NSCLC with PS2. Fast track designation was granted because NSCLC in PS2 patients is incurable with available therapy offering only modest benefit, and XYOTAX has the potential to demonstrate improvement over available therapy in these patients.

"We also submitted a SPA to the FDA for PGT307, a phase III trial of combination therapy for women with advanced lung cancer. The trial will study XYOTAX in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1 or 2," said James A. Bianco, M.D., President and CEO of CTI. "Pending FDA feedback, we anticipate that one or both of these trials would begin enrollment in the second quarter of 2007 with a targeted interim analysis in the first half of 2008."

Fast Track Designation

Fast track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. An expedited review as defined by the FDA user fee performance goals provides for a review within six months.

About XYOTAX

XYOTAX(TM) (paclitaxel poliglumex) is a 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 XYOTAX 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. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com/.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward- looking statements whether as a result of new information, future events, or otherwise.

Cell Therapeutics, Inc.
http://www.cticseattle.com/

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