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STELLAR 2 and 4 Pivotal Trials Demonstrate XYOTAX(TM) Produces Equivalent Survival While Significantly Reducing Serious Side Effects in the Treatment of First- or Second-Line Non-Small Cell Lung Cancer

Posted on: Monday, 2 May 2005, 09:00 CDT

SEATTLE, May 2 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and Nuovo Mercato: CTIC) announced the results of its phase III clinical studies of XYOTAX in non-small cell lung cancer (NSCLC), known as STELLAR 2 and 4. The studies were designed to determine if XYOTAX could increase the overall survival of patients while reducing serious side effects associated with the treatment of first-line or second-line NSCLC. Both trials demonstrated equivalent survival with significant reductions in serious side effects when compared to either docetaxel or gemcitabine/vinorelbine; although they missed their primary endpoints of superior overall survival. XYOTAX was administered in a convenient 10-minute infusion without the requirement for steroids and other premedications.

"The STELLAR studies are landmark trials in the treatment of non-small cell lung cancer and have all consistently shown that XYOTAX is as effective as conventional therapy for the treatment of lung cancer. We will continue our ongoing dialogue and work with FDA to register XYOTAX," stated James A. Bianco, M.D., president and CEO of CTI. "We are excited by the XYOTAX product profile demonstrated in these trials and believe an effective, better tolerated, less toxic taxane, with convenient administration, represents a preferable alternative to currently marketed treatments for patients with non- small cell lung cancer. At CTI, we're committed to making XYOTAX available as a treatment option for patients and physicians as quickly as possible."

STELLAR 4 Trial Results

STELLAR 4, a phase III clinical trial of XYOTAX versus either gemcitabine or vinorelbine for the first-line treatment of poor performance status (PS2) patients with NSCLC, resulted in a median survival of 7.3 months and 2 year survival of 15 percent for patients on the XYOTAX arm compared to 6.6 months and 10 percent for the control arm. Significantly more patients (p=0.003) completed full six courses of therapy on the XYOTAX arm compared to the control arm. Side effects were comparable on both arms, except for a significant reduction in all cardiac toxicities (p=0.013), gastrointestinal side effects (p=0.004), nausea (p=0.041), and vomiting (p=0.013). XYOTAX patients also had a significant reduction in severe hematologic toxicities including anemia (p<0.001), neutropenia (p=0.006), and thrombocytopenia (p=0.003). Hair loss was uncommon on both arms. Grade 3/4 neuropathy was observed more frequently on the XYOTAX arm (4 percent vs. 0 percent, p=0.007).

"The STELLAR 4 study is the largest controlled, randomized phase III trial of single-agent therapy ever conducted in PS2 patients," stated Alan Sandler, M.D., of Vanderbilt-Ingram Cancer Center and a principal investigator on the STELLAR 4 study. "This study shows that XYOTAX offers high-risk lung cancer patients a safer, more convenient alternative to the current mainstay single- agent standards, gemcitabine or vinorelbine, with efficacy comparable to platinum-based doublet therapy."

STELLAR 2 Trial Results

STELLAR 2, a phase III clinical trial of XYOTAX versus docetaxel for the second-line treatment of NSCLC patients, resulted in a 6.9 month median survival for both arms. Patients treated with XYOTAX had significantly fewer hematologic side effects than patients on the docetaxel arm, including grade 3/4 infections (p=0.01), severe neutropenia (p=0.001), and febrile neutropenia (p=0.002). XYOTAX therapy also resulted in a significant reduction in hair loss (p<0.001), fatigue (p=0.01), asthenia (general weakness, p=0.015), breathing problems (p=0.02), severe hypoxia (decreased oxygen in the blood, p=0.046), mucositis (p<0.001), and ocular toxicity (p=0.03). As expected, severe neuropathy on XYOTAX at a dose of 210 mg/m2 was higher than on the docetaxel arm (p<0.001).

"While XYOTAX had comparable efficacy, it resulted in a significant reduction in many side effects attributable to docetaxel therapy in relapsed lung cancer and can be delivered in a patient-convenient, 10 minute infusion, without hair loss or the need for premedications," stated Philip Bonomi, M.D., of Rush Cancer Institute and a principal investigator on the STELLAR 2 study. "As an oncologist, I've seen firsthand the serious impact side effects have on patients. Fatigue, weakness, infections, fever, and even hair loss, are not insignificant to patients undergoing treatment for their disease."

About XYOTAX(TM)

XYOTAX (paclitaxel poliglumex) is a 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 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.

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 or to be approved for use in non-small cell lung and ovarian cancers, risks that the results of any single STELLAR trial or the body of data from all 3 STELLAR trials will not be sufficient for FDA to approve XYOTAX for the treatment of 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. 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.

CONTACT: Investors, Leah Grant, 206-282-7100, or fax, 206-272-4434, orinvest@ctiseattle.com, or http://www.cticseattle.com/investors.htm, or media, SusanCallahan, 206-272-4472, or fax, 206-272-4434, or media@ctiseattle.com, orhttp://www.cticseattle.com/media.htm, both of Cell Therapeutics, Inc.

Web site: http://www.cticseattle.com/

Source: PRNewswire-FirstCall

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