CALGARY, June 20 - Oncolytics Biotech Inc. ("Oncolytics") announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The Principal Investigator is Dr. Monica Mita of the Cancer Therapy and Research Center, University of Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
"REOLYSIN® is one of the more exciting targeted agents under development in oncology," said Dr. Frank Giles, Director of the Institute for Drug Development. "Our investigators within the CTRC at UTHSCSA are very excited to begin studying potential synergy with standard cytotoxic agents and are eager to expand our studies into other tumor types and utilizing other chemotherapy partner regimens."
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
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