SEATTLE, Nov. 25 /PRNewswire-FirstCall/ -- Just one year after the initiation of the STELLAR 3 pivotal trial, Cell Therapeutics, Inc. (CTI) announced that it has completed enrollment in this trial with 370 patients accrued at a total of 80 sites across the United States and Europe. The trial is one of three phase III studies that CTI is conducting in non-small cell lung cancer (NSCLC). It compares XYOTAX(TM) (polyglutamate paclitaxel) at a paclitaxel equivalent dose of 210 mg/m2 combined with carboplatin (AUC 6) to paclitaxel (225 mg/m2) combined with carboplatin at an equivalent dose in high-risk NSCLC patients. The primary endpoint of the study is to determine if XYOTAX improves the survival of PS2 patients when compared to conventional paclitaxel based therapy.
“High-risk patients with a performance status 2 (PS2) whose disease has progressed to the point where they are unable to work and unable to get out of bed up to 50% of the time have a median survival on average of less than four to five months,” said Corey Langer, M.D., principal investigator on the STELLAR 3 trial and Medical Director of Thoracic Oncology at Fox Chase Medical Center. “This trial represents one of the largest studies ever conducted in PS2 patients. The rapidity with which CTI has been able to complete enrollment speaks to the unmet need for new therapies in this underserved population of critically ill patients.”
In November 2002, based on Special Protocol Assessment (SPA) acceptance from the Food and Drug Administration (FDA), CTI initiated two phase III trials of XYOTAX in the front-line treatment of PS2 patients with NSCLC. The SPA provides a process by which the FDA and the sponsor of the clinical trial can reach agreement on the suitability of the study design to support a potential registration strategy. Following its review of the proposed study design for the STELLAR trials, the FDA indicated that the choice of the PS2 population and the primary trial endpoints were acceptable.
In June, XYOTAX received fast track designation from the FDA for the PS2 lung cancer pivotal trials. The second PS2 trial, named STELLAR 4, evaluates whether XYOTAX (175 mg/m2) increases the survival rate in the front-line treatment of PS2 NSCLC patients when compared to either gemcitabine or vinorelbine. A third pivotal trial compares XYOTAX (210 mg/m2) as a single agent to the approved dose of docetaxel in a broader patient population that also includes lower-risk, PS0 and PS1 patients in the second-line treatment of NSCL cancer.
“We’re pleased to have completed enrollment in this trial, ahead of our originally projected year-end target,” said James A. Bianco, M.D., President & CEO of Cell Therapeutics, Inc. “This is the first of several major XYOTAX- related milestones for the Company and represents a significant amount of hard work and dedication by our employees, thought leaders and vendors in completing enrollment of this important landmark study.”
About XYOTAX(TM)
XYOTAX(TM) is an investigational pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), 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(TM) 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(TM) may be potentially more effective and have less severe side effects than currently available chemotherapeutics.
About Cell Therapeutics, Inc.
Based 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 announcement includes forward-looking statements relating to the development of the Company’s products and future clinical results 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(TM) include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX(TM) in particular including, without limitation, the progress, costs, and results of the ongoing clinical trials, the potential failure of XYOTAX(TM) 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(TM), 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.
Cell Therapeutics, Inc.
CONTACT: media, Candice Douglass, +1-206-272-4472, or fax,+1-206-272-4010, or media@ctiseattle.com; or investors, Leah Grant,+1-206-282-7100, or fax, +1-206-272-4010, or invest@ctiseattle.com, both ofCell Therapeutics, Inc.
Web site: http://www.cticseattle.com/