Oncolytics Biotech Inc. recently announced preliminary results from a mid-stage trial for its metastatic melanoma drug.
The Phase 2 clinical trial, evaluating the use of intravenous administration of Reolysin in combination with carboplatin and paclitaxel (REO 020) in patients with metastatic malignant melanoma who have failed on or more prior therapies or are not considered a candidate for standard first-line therapy, met its primary endpoint for the first stage of the trial. The primary objective of the trial is to assess the antitumor effect of the treatment regimen in this population in terms of objective response rates. Secondary objectives include assessment of progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus partial response (PR) plus stable disease (SD)) and duration, and to assess the safety and tolerability of the treatment for this population.
Dr. Devalingam, MD, PhD, MRCP, MRCP(I), clinical investigator in GI/thoracic oncology and drug development at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC) is the Principal Investigator of the trial.
The Phase 2 trial is a two stage design comprised of up to 18 evaluable patients to be treated in the first stage. If at least three patients demonstrated partial response, the study could proceed to the second stage, comprised of up to 43 patients. The endpoint was met after enrolling 14 patients. Three of the 14 patients demonstrated a partial response and seven patients had stable disease for a disease control rate of 71.5 percent.
“These preliminary results are very encouraging and support progressing to subsequent studies,” Dr. Brad Thompson, President and CEO of Oncolytics said in a statement. “Past clinical research has shown that Reolysin delivered intravenously replications in melanoma tumors, and this is the second clinical study to demonstrate responses in patients with Reolysin in combination with other therapeutics.”
The company said that they are currently conducting research to evaluate Reolysin in combination with other emerging treatments for several of patient sub-populations.
Source: Oncolytics Biotech Inc.
Last Updated: 5/23/13; 11:15AM EST