Oncolytics Biotech Inc. has announced preliminary results from a U.S. Phase 2 clinical trial (REO 017) using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanceda pancreatic cancer. The trial is being conducted at the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio (CTRC). The Principal Investigator is Dr. Monica Mita of the CTRC.
"When we opened the study we anticipated positive results based on preclinical models and on the high frequency of Ras pathway abnormalities in pancreatic cancer," said Dr. Monica Mita. "We are, however, impressed by the fact that the study met the endpoint so early. We are eager to complete the study and to proceed to the next step of development for this combination."
The trial is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with gemcitabine every three weeks. The study's primary objective is to determine the clinical benefit rate (complete response (CR) + partial response (PR) + stable disease (SD)) of REOLYSIN in combination with gemcitabine in patients with advanced or metastatic pancreatic adenocarcinoma with measurable disease who have not received any prior chemotherapy or biotherapy.
The secondary objectives are to determine progression-free survival, and the safety and tolerability of REOLYSIN when administered in combination with gemcitabine. Seventeen evaluable patients with pancreatic cancer were expected to be treated in the first stage and if three or more patients received clinical benefit, the study would then proceed to the next stage. This endpoint was met after six evaluable patients were enrolled. All patients treated reported symptomatic improvement.
Three of six patients showed SD for 12 weeks or greater. In addition, one patient had stable disease at nine weeks of treatment, but was taken off of the study for alternative treatment, and one patient had a PR of less than 12 weeks duration, and then died from a medical issue unrelated to treatment. The Company now intends to complete enrollment in the first stage of the study and then continue with further studies.
"This study is supportive of the decision to conduct the randomized Phase II study being sponsored by the NCI examining REOLYSIN in combination with carboplatin/paclitaxel," said Dr. Brad Thompson, President and CEO of Oncolytics.