Oncolytics Biotech Inc. has announced its financial results and operational highlights for the quarter ended June 30, 2011.
"We continue to build upon and progress through our research and development in an effort to maximize the future commercial potential of REOLYSIN®. In Q2, we focused our efforts on expanding our Phase III clinical trial in head and neck cancer, and expanding our clinical trial program by announcing a U.S. National Cancer Institute-sponsored clinical trial in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "We also received positive data from early stage studies in metastatic colorectal and non-small cell lung cancer studies, and secured a leading manufacturer for the clinical and commercial supply of REOLYSIN®, both significant steps forward in our plans to expand our development program."
Since April 1, 2011 the Company has announced:
Clinical Trial Results
• Interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. On initial histological analysis of the 10 treated patients, there was evidence of selective delivery of virus to tumour versus normal liver and viral replication in the majority (seven) of patients;
• A presentation covering interim preliminary results from a Phase 2 clinical trial using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours at the International Association for the Study of Lung Cancer World Conference on Lung Cancer.
Response evaluation as of the date of presentation in 21 patients showed six partial responses (PR) (28.6%), 13 stable disease (SD) (61.9%), and two progressive disease (PD) (9.5%), translating into a clinical benefit rate (complete response (CR)+PR+SD) of 90.5% and a response rate (CR+PR) of 28.6%;
Ongoing Clinical Program
• The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma;
• A commercial supply agreement with SAFC, a Division of Sigma-Aldrich Corporation, for the commercial manufacture of REOLYSIN. Under the terms of the agreement, SAFC will perform process validation of the product, will continue to supply clinical requirements and will supply commercial material upon approval of the product; and
• The appointment of George M. Gill, MD as Chief Medical Officer. Dr. Gill has been Senior Vice President of Clinical Safety and Regulatory Affairs and an officer of Oncolytics since 2002.