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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).