SEATTLE, Feb. 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX: CTIC) announced that the U.S. Food and Drug Administration (FDA) confirmed that XYOTAX, a novel biologically-enhanced version of one of the most used cancer drugs, Taxol®, qualifies for fast track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC), which is currently being studied in the PIONEER clinical trial. The Company has initiated a number of clinical sites and is currently enrolling patients on the PIONEER trial, the first approval trial for lung cancer exclusively targeting women.
Fast Track Designation
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. 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 the PIONEER clinical trial
The PIONEER trial is targeting approximately 170 sites - about half in the United States with the balance throughout the rest of world, including Eastern Europe and Latin America. CTI expects enrollment of the 600 PS2 chemotherapy-naive women with advanced stage NSCLC to take about 12 to 14 months. For more information on the PIONEER trial, please visit www.cticseattle.com.
About XYOTAX
XYOTAX (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, 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. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. 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. 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 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 or be approved for use in non-small cell lung cancer, risks that the effect of estrogen seen in preclinical studies do not result in a gender effect or improvement in survival of women with non-small cell lung cancer, risks related to the initiation, accrual, and results of the PIONEER trial, 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. 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. Taxol® is a registered trademark of Bristol-Myers Squibb Co.
Source: Cell Therapeutics, Inc.
