Bingo:
CTI to Report Results from STELLAR 3 Pivotal Trial of XYOTAX(TM) in Non-Small Cell Lung Cancer Ahead of Previous Guidance
Thursday February 17, 7:00 am ET
SEATTLE, Feb. 17 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and Nuovo Mercato: CTIC) today announced that it now expects results from its pivotal trial of XYOTAX(TM) in non-small cell lung cancer (NSCLC), known as STELLAR 3, in early to mid March. CTI had previously reported that it expected results from the STELLAR 3 trial in late March or early April.
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"The clinical research organization (CRO) has recently notified CTI that they may have the database clean and ready earlier than expected," stated Scott Stromatt, M.D., Senior VP for Clinical and Regulatory Development at CTI. "Based on this revised timeline, we expect to be in a position to have the results for submission of a late breaking abstract ahead of the ASCO deadline."
About STELLAR Trials
The STELLAR trials are the largest randomized trials to date in either second-line non-small cell lung (NSCL) cancer or front-line PS2 NSCL cancer patients.
STELLAR 2 is a phase III clinical trial of XYOTAX 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 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 versus either gemcitabine or vinorelbine for the potential front-line treatment of poor performance status (PS2) patients with NSCL cancer.
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 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 CTI's products under development include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the survival estimates in clinical data regarding XYOTAX treatment and the possibility that preliminary indications of results from clinical trial data may vary materially from final results of clinical trials, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung and ovarian cancers, 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.
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