Encouraging Survival Estimates in Non-Small Cell Lung Cancer Push XYOTAX(TM) Pivotal Trial Data Release to End of First Quarter 2005
Thursday December 16, 10:00 am ET
XYOTAX Trial Updates Presented at Wachovia's 'Ten for '05' Biotechnology Conference
NEW YORK, Dec. 16 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) presented an update on the clinical development of XYOTAX, including survival estimates for its STELLAR 3 and 4 trials in non-small cell lung cancer (NSCLC), at the Wachovia Capital Markets' Ten for '05 Biotechnology Conference. Earlier this year, CTI extended the timelines for the pivotal trial data release due to higher than historically predicted survival rates. In his update today, James A. Bianco, M.D., President and CEO of CTI, said that at the current rate the trials would not reach the 311 events (deaths) required for data analysis until early January and February next year for STELLAR 3 and 4, respectively. As of December 9, 281 deaths have been reported in the doublet therapy trial, STELLAR 3, and 222 events among 388 patients who received XYOTAX at the 175 mg/m2 dose or control in the single agent trial, STELLAR 4. The STELLAR trials are the largest trials ever conducted in the PS2 population and address very important unmet medical needs in the treatment of NSCLC.
"With a median follow up of over one year for STELLAR 3 and almost eight months for STELLAR 4, the increase in the number of doses of chemotherapy being administered as well as the survival estimates are very encouraging," stated Bianco. "On the STELLAR 3 trial, 36 percent of the patients received six cycles of the doublet therapy, with 50 percent of the patients on STELLAR 4 receiving four to six cycles of single agent therapy. Recently published results report that for front-line treatment of NSCLC, PS2 patients tolerate on average only two cycles of therapy, with only 10 percent to 20 percent being alive at one year following single agent or doublet therapy, respectively. Because the trials have not yet reached the number of events required for analysis, the study data remains blinded; however, we're observing 'blended' rates of tolerability and survival that are substantially outside the range of what is in the literature."
In addition to the STELLAR 3 and 4 updates, Bianco presented information on the clinical development of XYOTAX in ovarian cancer. The Company, in conjunction with the Gynecologic Oncology Group (GOG), has advanced a phase II trial in relapsed ovarian cancer patients to the second stage of the study based on meeting the protocol-defined response criteria and plans to initiate its phase III trial in ovarian cancer in January.
About STELLAR Trials
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. |
