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STELLAR 3 Pivotal Trial Shows XYOTAX(TM) Reduces Side Effects of Paclitaxel With Equivalent Efficacy in the Treatment of Non-Small Cell Lung Cancer (NSCLC) Patients
MONDAY, MARCH 07, 2005 7:00 AM
- PR Newswire

SEATTLE, March 7, 2005 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (CTIC) announced that while a phase III study of XYOTAX in combination with carboplatin, known as STELLAR 3, missed its primary endpoint, it met statistical significance for non-inferiority of survival compared to paclitaxel in combination with carboplatin. Patients who received the XYOTAX/carboplatin regimen had significantly less hair loss and a reduction in other side effects, including muscle and joint pain, cardiac symptoms, and an overall reduction in neurologic toxicities compared to patients who received the standard paclitaxel/carboplatin regimen. The XYOTAX regimen was given in a convenient 10-minute infusion without the requirement for steroids and other premedications. Hypersensitivity reactions were rare on the XYOTAX/carboplatin arm of the study despite the lack of premedications. Complete research findings from this trial are expected to be presented at the American Society of Clinical Oncology (ASCO) meeting in mid-May.

"When one controls for validated risk factors, including weight loss, LDH (a marker of tumor aggressiveness), and calcium levels, the single most important and highly statistically significant determinant of survival in the STELLAR 3 study was whether the patient received XYOTAX instead of paclitaxel," noted Jack W. Singer, M.D., Chief Medical Officer at CTI. "This intent-to-treat analysis, using a Cox multivariate model, was pre-specified in the protocol`s statistical analysis plan. It provides a strong argument for a survival benefit for XYOTAX over paclitaxel that is not apparent in the primary analysis."

The multi-center, randomized, controlled phase III study compared XYOTAX (210mg/m2) in combination with carboplatin (AUC 6) to paclitaxel (225mg/m2) in combination with carboplatin (AUC 6) every three weeks for up to six cycles of therapy in 400 poor performance status (PS2) NSCLC patients.

"We are disappointed that XYOTAX in combination with carboplatin showed equal efficacy after the unprecedented blended median and 1-year survival we saw on the trial. We are encouraged by the preliminary analysis, which demonstrates a significant XYOTAX treatment effect, reduction in toxicities, and increased patient convenience," stated James A. Bianco, M.D., President and CEO of CTI. "We look forward to our upcoming discussion with FDA regarding our STELLAR 2 amendment and the preliminary results of STELLAR 3, as well as having results from STELLAR 2 in April, with STELLAR 4 results coming in shortly thereafter."

About the STELLAR Trials

The STELLAR trials are among the largest randomized trials to date in either second-line non-small cell lung cancer (NSCLC) or front-line PS2 NSCLC patients.

STELLAR 2 is a phase III clinical trial of XYOTAX versus docetaxel for the potential second-line treatment of NSCLC patients.

STELLAR 3 is a phase III clinical trial of carboplatin in combination with either XYOTAX or paclitaxel for the potential front-line treatment of poor performance status (PS2) patients with NSCLC.

STELLAR 4 is a phase III clinical trial of XYOTAX versus either gemcitabine or vinorelbine for the potential front-line treatment of poor performance status (PS2) patients with NSCLC.

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 to enhance the safety and efficacy of cancer therapy and make 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, risks that the survival benefit from the STELLAR 3 trial will not be sufficient for FDA approval for lung cancer, risks that unsatisfactory results from either or both of the STELLAR 2 or 4 trials will not provide sufficient data for FDA approval for lung cancer, the potential failure of XYOTAX to prove safe and effective for treatment of disease, 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, 10-Q, and 8-K. 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.

SOURCE Cell Therapeutics, Inc.

Copyright (C) 2005 PR Newswire. All rights reserved.