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| September 28, 2005 | Major produces |
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Oncology ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- At the 2005 Annual Meeting of the American Society of Clinical Oncology (ASCO), Cell Therapeutics, Inc. (CTI) (Nasdaq and Nuovo Mercato: CTIC) reported initial data from a phase I study of weekly XYOTAX given in combination with radiation for patients with esophageal and gastric cancer. Of the 11 patients with loco-regional disease evaluable for tumor response, four patients (36 percent) achieved a complete disappearance of their tumor or complete response and five patients (45 percent) achieved a 50 percent or greater shrinkage of their cancer, a partial response, for an overall objective response rate of 81 percent.
No grade 3/4 toxicities were observed at the maximum tolerated dose of 70 mg/m2/week given for six weeks. At the 80mg/m2 dose level two patients had grade 3 esophagitis and one patient had grade 4 neutropenia.
"Preclinical data suggest that XYOTAX is a more effective radiation sensitizer than paclitaxel. XYOTAX has a radiation enhancement factor of 4 to 8 versus 1.5 to 2 for paclitaxel. This study has defined the optimal dose of XYOTAX with radiation and shown that XYOTAX is an important radiation sensitizer for esophageal and gastric cancer with impressive anti-tumor activity," stated Howard Safran, M.D., of Brown University and principal investigator on the study. "The side effect profile, the 10-minute infusion time, and the lack of hair loss along with these encouraging response rates make us eager to broaden our clinical experience with this novel agent."
The objective of the study was to determine the maximum tolerated dose of weekly XYOTAX in combination with 50.4 Gy concurrent radiation in patients with esophageal or gastric cancer. Twenty patients were treated with five dose levels of XYOTAX of 40 mg/m2 (three patients), 50 mg/m2 (four patients), 60 mg/m2 (four patients), 70 mg/m2 (five patients) and 80 mg/m2 (four patients). Sixteen patients had esophageal cancer and four had gastric cancer.
For more information about this presentation or about our clinical trials, please visit our website: http://www.cticseattle.com.
About XYOTAX
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 http://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 potential failure of XYOTAX to prove safe and effective in combination with radiation , 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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