Earlier today, Oncolytics Biotech Inc, a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, and NCIC Clinical Trials Group (CTG) at Queen’s University in Kingston, Ontario, announced that they will collaborate in a randomized Phase II study of Reolysin? in patients with advanced or metastatic colorectal cancer.
This trial is a second clinical trial Oncolytics will be conducting with the NCIC CTG, a cancer clinical trials cooperative group that conducts Phase I-III trials testing anti-cancer and supportive therapies across Canada and internationally.
Commenting on the agreement, Dr. Brad Thompson, President and CEO of Oncolytics said that “This study will build on both our early preclinical and clinical colorectal cancer work, as well as preclinical research combining Reolysin with bevacizumab.” Thompson also noted that the development team will to continue expanding the clinical program to include randomized studies of other frequently diagnosed cancers.
Mechanism of action
Reolysin is a wild type reovirus (reovirus serotype 3; Dearing strain) which replicates preferentially in Ras-activated cancer cell. Due to inhibition of the dsRNA-activated protein kinase, Reolysin can infect and selectively destroy cancer cells. The trial drug is generally well tolerated. The community-acquired (flu-like) infection is mild and limited to the upper respiratory and GI tract. The virus inhibits the double-stranded RNA-activated protein kinase (PKR) and replicates specifically in transformed cells possessing an activated Ras pathway producing lysis, while leaving normal cells unharmed. In in vitro and in vivo studies in Ewing’s sarcoma, rhabdomyosarcoma, synovial sarcoma, and osteosarcoma cell lines revealed significant antitumor activity.
Open-label study
The study will be an open-label, randomized, non-blinded, Phase II clinical study of Reolysin,given in combination with FOLFOX-6 plus bevacizumab (Avastin?, Genentech/Roche) versus FOLFOX-6 plus bevacizumab alone. Approximately 50 response evaluable patients will be enrolled in each arm, after a six to nine patient safety run in.
Colorectal cancer
Colorectal cancer, also known as bowel cancer, is the most common cancer globally today. It is the second most common tumor type among both men and women (after lung tumors). While the cancer tend to develop in men at a younger age, statistics show that the disease affects men and women in equal numbers. In Western Europe, approximately 2% of over 50-year-olds will eventually develop colorectal cancer. In more than 40% of them the cancer is already at an advanced stage. For these patients surgery is probably the most likely option. According tothe Canadian Cancer Society, 22,200 Canadians werediagnosedwith colorectal cancer in 2011 andmore than 8,900 Canadians were expected to die from the disease. The American Cancer Society estimates that 143,460 Americans will be diagnosed with colorectal cancer and 51,690 Americans are expected to die of the disease in 2012.
For more information:
– Ghalib MH, Desai KK, Gollamudi R, Chaudhary I, Einstein M, Coffey M, Mettinger K, et al. Dose escalation and pharmacodynamic study of intravenous adminstration of Reolysin, a live replication competent RNA virus in patients with advanced solid tumors. J Clin Oncol 27:15s, 2009(suppl; abstr 3583)
– Arkenau H, Evans J, Lokelma M, Roxburgh P, Morisson R, Coffey C, Gill G, et al. A phase I study of the combination of intravenous Reolysin (REO) and gemcitabine (GEM) in patients (pts) with advanced cancer. J.Clin Oncol 27:15s, 2009 (suppl; abstr 3584)
Clinical trials
NCT01274624 – Study of Reolysin? in Combination With FOLFIRI in Patients With Oxaliplatin Refractory/Intolerant KRAS Mutant Colorectal Cancer
NCT01166542 – Efficacy Study of Reolysin? in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
NCT00998322 – A Study of Reolysin in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma.
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