Cell Therapeutics, Inc. Completes Enrollment in Third Pivotal Trial of XYOTAX(TM) in Lung Cancer
Monday July 26, 7:01 am ET
Trial Represents One of the Largest Randomized Studies in Relapsed Lung Cancer
SEATTLE, July 26 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato: CTIC) announced that it has completed enrollment in the STELLAR 2 XYOTAX(TM) pivotal trial; one of the largest randomized studies conducted in relapsed lung cancer and one of three phase III studies that CTI is conducting in non-small cell lung cancer (NSCLC). The primary objective of the study is to determine if XYOTAX(TM) improves the duration of patient survival when compared to docetaxel, the currently approved treatment for patients with lung cancer that has recurred following front-line treatment.
"This is a significant accomplishment as this study is of sufficient size to provide a definitive answer on a potentially more effective, less toxic treatment for patients with relapsed lung cancer," noted Philip Bonomi, M.D., principal investigator on the STELLAR 2 trial and Director of the Division of Hematology/Oncology at Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois. Bonomi further stated, "Although the survival outcomes for these pivotal trials remain blinded, the preliminary blinded overall survival estimates for all patients and safety data review by the STELLAR investigators is encouraging. We expect these data will be highlighted in plenary sessions at ASCO 2005, as all three trials potentially address very important unmet medical needs in the treatment of patients with lung cancer."
"The completion of enrollment in a trial of this scope demonstrates the dedication of CTI's employees and is a significant milestone for the company," stated James A. Bianco, M.D., President and CEO of CTI. "Now that we have met our enrollment goals, we will turn our undivided attention to completing the trials to prepare for a projected NDA filing and the potential launch of XYOTAX(TM) next year," he added.
The trial is a multinational, phase III, open label study of patients randomized equally between one of two treatment arms -- XYOTAX(TM) (paclitaxel poliglumex) at a paclitaxel equivalent dose of 210 mg/m2, or docetaxel (75 mg/m2) in the second-line treatment of NSCLC patients who have failed a prior platinum containing front-line regimen. Unlike STELLAR 3 and 4 patients who are performance status (PS) 2, STELLAR 2 enrolled patients with a performance status of 0, 1 or 2. To minimize potential imbalances between the two treatment arms, randomization was stratified by disease stage, performance status, gender, and history of prior therapy. In addition to the primary endpoint of survival, the study is designed to evaluate disease control rates and the toxicity profile of XYOTAX(TM).
About STELLAR Trials (Selective Targeting for Efficacy in Lung cancer Lower Adverse Reactions)
STELLAR 2 is a phase III clinical trial of XYOTAX(TM) versus docetaxel for the potential second-line treatment of NSCL cancer patients.
STELLAR 3 is a phase III clinical trial of carboplatin in combination with either XYOTAX(TM) or paclitaxel for the potential front-line treatment of poor performance status (PS2) patients with NSCL cancer.
STELLAR 4 is a phase III clinical trial of XYOTAX(TM) versus either gemcitabine or vinorelbine for the potential front-line treatment of poor performance status (PS2) patients with NSCL cancer.
About XYOTAX(TM)
XYOTAX(TM) is an investigational pharmaceutical that links paclitaxel, the active ingredient in Taxol®, 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... |
