The News

XYOTAXTM Pivotal Trial in Non-Small Cell Lung Cancer, STELLAR 3, Reaches Required Number of Events

27/01/2005

STELLAR Trial Updates Presented at the Piper Jaffray Healthcare Conference

Jan. 27, 2005 Seattle — At the Piper Jaffray Healthcare Conference, Cell Therapeutics, Inc. (CTI) (NASDAQ and Nuovo Mercato: CTIC) announced that it is on track to report results in late March or early April from the XYOTAXTM pivotal trial in non-small cell lung cancer (NSCLC), known as STELLAR 3, now that the required number of events (deaths) for data analysis has been reached. Due to prolonged survival rates in this blinded trial, CTI had to delay the data analysis from the date anticipated when the trial was initiated in November 2002. The company also updated its progress on the two other ongoing pivotal trials in NSCLC, STELLAR 4 and STELLAR 2. In STELLAR 4, approximately 250 of the 313 required events have been reached and in STELLAR 2, 578 out of the 635 required events have been reached. CTI expects results from STELLAR 4 in the second quarter of this year and results from STELLAR 2 in the third quarter.

“The median and one-year survival estimates in STELLAR 3 are very encouraging and longer than data reported from prior trials of doublet chemotherapy in poor performance status lung cancer patients,” commented Scott Stromatt, M.D., Senior VP for Clinical and Regulatory Development at CTI. “The XYOTAX product team is working diligently to have data available for submission as a late-breaking abstract at the American Society of Clinical Oncology meeting. Analyzing and reporting the STELLAR trial results is the team’s number one priority as it is pivotal for our NDA submission.”

About STELLAR Trials
STELLAR, which stands for Selective Targeted Efficacy in Lung cancer, Lower Adverse Reactions, are the largest randomized trials to date in either second line lung cancer or front line PS2 lung 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™
XYOTAX (paclitaxel poliglumex) is a 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 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.

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.

For further information please contact:
Investors
Cell Therapeutics, Inc.
Leah Grant
T:  206.282.7100 F: 206.272.4434
E:  invest@ctiseattle.com
www.cticseattle.com/investors.htm
 
Media
Cell Therapeutics, Inc.
Susan Callahan
T: 206.272.4472 F: 206.272.4434
E: media@ctiseattle.com
www.cticseattle.com/media.htm