REO 006

Local Administration of REOLYSIN® in Combination with Radiation for Patients with Advanced Cancers

In May 2010, Oncolytics announced the publication of positive results in its completed Phase Ia/Ib clinical trial to evaluate the feasibility, safety and antitumor effects of intratumoral administration of REOLYSIN^® in combination with radiation in patients with advanced cancers.
 
A total of twenty-three patients received a range of two to six intratumoral doses of REOLYSIN^® at escalating dosages up to a maximum of 1 x 10¹⁰ TCID₅₀ with a constant localized radiation dose of either 20 Gy or 36 Gy. Of the seven evaluable patients in the low-dose (20 Gy) 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 (two). In the high-dose (36 Gy) radiation group, five of seven evaluable patients had PRs (two with malignant melanoma and one each with lung adenocarcinoma, colorectal adenocarcinoma and ovarian adenocarcinoma) and two had SD (malignant melanoma), for a clinical benefit rate (PR + SD + complete response) of 100%. The treatment was tolerated well in all cohorts, with no dose-limiting toxicities, and no maximum tolerated dose was reached.
 
The primary objective of the study was to determine the maximum tolerated dose, dose-limiting toxicity and safety profile of REOLYSIN^® when administered intratumorally to patients receiving radiation treatment. A secondary objective was to examine any evidence of antitumor activity. The principal investigator for the study was Dr. Kevin Harrington of the Institute of Cancer Research and the Royal Marsden Hospital in London. Patients were enrolled at both the Royal Marsden Hospital and St. James's Hospital, also in the United Kingdom.
 
Links:

• May 18, 2010: Two-Stage Phase I Dose-Escalation Study of Intratumoral Reovirus Type 3 Dearing and Palliative Radiotherapy in Patients with Advanced Cancers (PDF)

• May 18, 2010: Oncolytics Biotech Inc. Announces Publication of Phase I Clinical Trial Results in Clinical Cancer Research (Press Release)

• December 21, 2007: Oncolytics Biotech Inc. Completes Patient Enrollment in UK Phase Ia/Ib Combination REOLYSIN^®/Radiation Clinical Trial (Press Release)

• October 24, 2007: Oncolytics Biotech Inc. Collaborators to Present Positive Interim Results of UK Phase Ia/Ib Combination REOLYSIN^® and Radiation Clinical Trial (Press Release)

• September 28, 2007: Oncolytics Biotech Inc. Reports Positive Interim Results of UK Phase Ia/Ib Combination REOLYSIN^® and Radiation Clinical Trial (Press Release)