CALGARY, Sept. 2 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) 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(R) in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours. The Principal Investigator is Dr. Miguel Villalona-Calero, Professor Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center.
"In this era of personalized cancer treatment, we are quite excited about this trial," said Dr. Villalona-Calero. "Although we have had for some time treatments that target EGFR, K-RAS has been an elusive target. REOLYSIN(R) has the potential to target K-RAS activated tumors, possibly enhancing the beneficial effects produced by chemotherapy."
"This trial gives Oncolytics the opportunity to treat NSCLC patients in a first-line clinical setting," said Dr. Brad Thompson, President and CEO of Oncolytics. "Assuming we achieve an acceptable response rate, the combination of REOLYSIN(R) with paclitaxel and carboplatin for NSCLC would be a strong candidate for registration studies."
This trial is a single arm, two-stage, open-label, Phase 2 study of REOLYSIN(R) given intravenously with paclitaxel and carboplatin every 3 weeks. Patients will receive four to six cycles of paclitaxel and carboplatin in conjunction with REOLYSIN(R), at which time REOLYSIN(R) may be continued as a monotherapy. It is anticipated that up to 36 patients will be treated in this trial.
Eligible patients include those with metastatic or recurrent NSCLC with
K-RAS or EGFR-activated tumours, who have not received chemotherapy
treatment for their metastatic or recurrent disease. Patients must have
demonstrated mutations in K-RAS or EGFR, or EGFR
|SOURCE Oncolytics Biotech Inc.|
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