Oncolytics Biotech® Starts Enrolment in U.S. Phase 2 Pancreatic Cancer Clinical Trial
News May 27, 2010
Oncolytics Biotech Inc. has announced that the Cancer Therapy & Research Center at the University of Texas Health Science Center in San Antonio (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. The Principal Investigator is Dr. Monica Mita of the CTRC.
"Pancreatic cancer has a dismal prognosis and no drugs have shown significant clinical benefit when added to gemcitabine for this patient population," said Dr. Mita. "We are extremely pleased to initiate this study and to have this promising treatment option for our patients."
"There is good rationale for moving forward with this first-line treatment combination, as our completed U.K. combination REOLYSIN and gemcitabine clinical trial (REO 009) in patients with various advanced cancers resulted in disease control for a majority of the evaluable patients," said Dr. Brad Thompson, President and CEO of Oncolytics.
The trial (REO 017) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with gemcitabine every three weeks. Up to 33 patients are expected to be treated in this trial.
Eligible patients include those with advanced or metastatic pancreatic cancer with measurable disease who have not received any prior chemotherapy or biotherapy.
The primary objective of the Phase 2 trial is to determine the clinical benefit rate (complete response (CR) + partial response (PR) + stable disease (SD)) of intravenous multiple doses of REOLYSIN in combination with gemcitabine in patients with advanced or metastatic pancreatic cancer. The secondary objectives are to determine the progression-free survival, and to determine the safety and tolerability of REOLYSIN when administered in combination with gemcitabine.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.