Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that a paper entitled “Two-Stage Phase I Dose-Escalation Study of Intratumoural Reovirus Type 3 Dearing and Palliative Radiotherapy in Patients with Advanced Cancers,” has been published in the online version of the journal Clinical Cancer Research.
The paper covers final results from a Phase Ia/Ib U.K. clinical trial (REO 006) investigating the intratumoural delivery of REOLYSIN(R) in combination with radiation to treat patients with advanced cancers. A total of 23 patients received a range of two to six intratumoural doses of REOLYSIN at escalating dosages up to a maximum of 1×10(10) TCID(50) with a constant localized radiation dose of either 20 Gy or 36 Gy. The principal investigator for the study is Dr. Kevin Harrington from The Institute of Cancer Research and The Royal Marsden Hospital, London, U.K.
Of the seven evaluable patients in the low-dose (20Gy) radiation group, two patients had a partial response (PR) (esophageal adenocarcinoma and squamous cell carcinoma (SCC) of the skin) and five had stable disease (SD) including patients with malignant melanoma, pancreatic adenocarcinoma, SCC of the larynx and SCC of the skin (2). In the high-dose (36Gy) radiation group, five of seven evaluable patients had PRs (malignant melanoma (2), lung adenocarcinoma, colorectal adenocarcinoma, and ovarian adenocarcinoma) and two had SD (malignant melanoma).
“All 14 patients considered evaluable for treatment response in this study had SD or better for a clinical benefit rate of 100%,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We believe that this study clearly demonstrates that the combination of low dose radiation and REOLYSIN is well tolerated and that the very high response rate warrants further investigation.”
The primary objective of the trial was to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of REOLYSIN when administered intratumourally to patients receiving radiation treatment. A secondary objective was to examine any evidence of anti-tumour activity. The treatment was well tolerated in all cohorts, with no DLTs, and no MTD was reached.
“This is an early study but the absence of any significant side-effects is extremely reassuring for future trials in patients receiving radiotherapy with the aim of curing their cancer,” said Dr. Harrington.
Oncolytics Biotech Inc.