SEATTLE, Aug. 23 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX: CTIC) today announced that data from a phase I study of weekly XYOTAX given in combination with radiation for patients with esophageal or gastric cancer was published in the August edition of the American Journal of Clinical Oncology. Twenty-one patients were treated to evaluate the safety of the regimen and to determine the maximum tolerated dose of XYOTAX in combination with 50.4 Gy concurrent radiation. Of the 12 patients with loco-regional disease in whom tumor responses were evaluated, four patients (33 percent) achieved a complete response and seven patients (58 percent) achieved a partial response (50 percent or greater shrinkage of their tumor), for an overall objective response rate of 91 percent.
“XYOTAX is an important new radiation sensitizer in esophageal cancer. Preclinically, XYOTAX is a much more potent radiation sensitizer than paclitaxel,” stated Howard Safran, M.D., of Brown University and principal investigator on the study. “XYOTAX may replace paclitaxel as the most important radiation sensitizer in solid tumors.”
At the maximum tolerated dose of 70 mg/m2/week given for six weeks, one patient had grade 3 esophagitis. There were no grade 3/4 toxicities at dose levels below 70 mg/m2/week. At the 80mg/m2 dose level three of four patients had dose limiting toxicities including grade 3 esophagitis/gastritis (2 patients), grade 3 dehydration (1 patient), and grade 4 neutropenia (1 patient). Except for the four patients who experienced dose limiting toxicity, all patients completed the full six weeks of concurrent chemoradiation.
“The safety profile of XYOTAX and its protocol-defined dose with standard course radiation coupled with its impressive anti-tumor activity provide clinical support for preclinical studies demonstrating its great potency as a radiosensitizer,” stated Jack W. Singer, Chief Medical Officer of CTI. “A follow-on study in combination with cisplatin and radiation is currently in progress.”
About the Study
The objective of the study was to determine the maximum tolerated dose and dose limiting toxicities of weekly XYOTAX in combination with 50.4 Gy concurrent radiation in patients with esophageal or gastric cancer. Twenty-one 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 (six patients) and 80 mg/m2 (four patients). Sixteen patients had esophageal cancer and five had gastric cancer. Preliminary data on this study was presented at the 2005 meeting of the American Society of Clinical Oncology (ASCO).
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About XYOTAX
XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue’s exposure to high levels of unbound, active chemotherapy and its associated toxicities. 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 distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
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 XYOTAX 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 for treatment of esophageal and gastric 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. Pursuant to U.S. law, 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.
Source: Cell Therapeutics, Inc.
