REO 018

Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Platinum-Refractory Head and Neck Cancers

In September 2012, Oncolytics provided and update on its Phase III trial of REOLYSIN^® in combination with carboplatin and paclitaxel for the treatment of head and neck cancers (REO 018). The company had conducted an internal analysis of the blinded combined clinical data for all 80 patients enrolled in the first stage of the study. The study has continued to remain blinded.

At the time of the analysis, 23 patients of the 80 had not yet progressed but were included for the purposes of analysis. The median evolving progression free survival (PFS) of the 80 patients, which comprises the combined control and test groups, was greater than expected, as was the best response rate. On further examination, it was observed that patients, for whom only metastatic disease was being measured by clinicians, were responding differently to treatment than patients who had local regional head and neck disease. Patients in whom only metastatic disease was measured had a median evolving PFS of 120 days, which was statistically significantly greater than those patients with a noted local regional head and neck tumor.

The Company had consulted with its principal investigators, the independent statistician for the study and, on September 10, 2012, met with the U.S. Food and Drug Administration in Washington, D.C. Based on these discussions, the Company expanded enrollment in the first stage to include 160 patients, all of whom have now been enrolled.  

Oncolytics intends to introduce an additional segregation to differentiate between two patient populations; patients with local recurrent disease, with or without metastases, and patients with distal metastases. Based on the analysis of the 160 patients, Oncolytics expects to generate randomized data from the two discrete patient populations.  The Company believes this will provide a sufficient number of patients to conduct a meaningful analysis of the two identified patient groups, as well as increased powering for the overall analysis.

Oncolytics intends to treat this expanded first stage of the REO 018 clinical trial as a separate supportive study to a planned registration study that will be similar to, and take the place of, the original second stage of the REO 018 clinical trial. The Company intends to submit protocol amendments to regulators in the immediate near term to reflect these changes. It will require additional time to follow the expanded group of patients and allow the evolving PFS data to mature.
 
 
Links:

• December 13, 2012: Oncolytics Biotech Inc. Announces Positive Top Line REOLYSIN® Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers

• September 12, 2012: Oncolytics Biotech Inc. Provides Update on Phase III Study of REOLYSIN® in Head and Neck Cancers
   

• June 20, 2012: Oncolytics Announces Independent Data Monitoring Committee Recommends Continued Enrollment in Phase III Study of REOLYSIN® in Head and Neck Cancers Following Review of Safety Data

• April 2, 2012: Oncolytics Biotech Completes Enrollment  in First Stage of Phase III Study in Head and Neck Cancers (Press Release)

• April 1, 2012: Trials Show Promise of Human Virus to Treat Head and Neck Patients (Institute of Cancer Research Press Release, External Link)

• July 19, 2010: Oncolytics Biotech Inc. Receives No Objection Letter from Health Canada to Conduct Phase III Trial of REOLYSIN^® in Head and Neck Cancers (Press Release) 

• June 1, 2010: Oncolytics Biotech Inc. Receives Approval from Belgium FAMHP to Conduct Phase III Trial for REOLYSIN^® in Head and Neck Cancers (Press Release)

• May 25, 2010: Oncolytics Biotech Inc. Announces Opening of Enrollment in Phase III Trial for REOLYSIN^® in Head and Neck Cancers (Press Release)

• February 16, 2010: Oncolytics Biotech Inc. Receives Approval from the UK MHRA to Conduct Phase III Trial for REOLYSIN^® in Head and Neck Cancers (Press Release)

• October 2, 2009: Oncolytics Biotech Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase III Trial for REOLYSIN^® in Head and Neck Cancers (Press Release)

• REO 018 on Clinical Trials.gov (External Link)