We are eager to advance REOLYSIN into clinical testing in new indications where we believe the product may have sound clinical potential, such as colorectal cancer- Brad Thompson, Oncolytics Biotech CEO
Calgary, Alberta (Vocus/PRWEB) January 18, 2011
Colorectal cancer is the third leading cause of cancer death among both men and women in the US. The American Cancer Society estimates that nearly 143,000 Americans were diagnosed with colorectal cancer and an estimated 51,370 died from the disease in 2010.
Calgary-based biotechnology company, Oncolytics Biotech Inc., is opening a new front in the war against this disease. The company is seeking to enroll patients with a form of colorectal cancer in a US Phase I study, where the patients will be treated with a live biologic therapy called REOLYSIN.
Oncolytics’ proprietary formulation of the human reovirus, REOLYSIN works by replicating inside of, and subsequently destroying cancer cells that have a certain characteristic (called an activated RAS pathway) that is shared by about two-thirds of all cancers. The drug targets the tumor cells and protects healthy, normal tissue. REOLYSIN appears to kill off these cancer cells by rupturing their walls, creating a chain reaction of “explosions” that rip through tumors.
The study is expected to enroll 12 to 20 patients, including those with histologically confirmed cancer of the colon or rectum with Kras mutation and measurable disease. The trial is a Phase I dose escalation study with three dose levels, comprising cohorts of three to six patients, to determine a maximum tolerated dose and dose-limiting toxicities with the combination of REOLYSIN and another compound called FOLFIRI, which consists of Folinic acid, Fluorouracil and Irinotecan. The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at The Albert Einstein College of Medicine in New York.
“We are eager to advance REOLYSIN into clinical testing in new indications where we believe the product may have sound clinical potential, such as colorectal cancer,” says Dr. Brad Thompson, president and CEO of Oncolytics. “A range of preclinical and clinical work with REOLYSIN have indicated its efficacy in colorectal cancer, and our new Phase I study is designed to tell us more.”
The rationale for conducting the study is based on signals of efficacy seen in a range of preclinical and clinical work with REOLYSIN. This includes a National Cancer Institute screen of seven colorectal cancer cell lines (four with ras mutations), all of which were susceptible to REOLYSIN; preclinical research into the efficacy of REOLYSIN in combination with various chemotherapeutic agents in colorectal cancer cell lines; observation of CEA responses and stable disease in colorectal patients in a phase I study of REOLYSIN as a monotherapy; and interim results from a translational study with REOLYSIN as a monotherapy that is currently ongoing, which showed evidence of viral replication and tumour cell death in four of six patients with metastatic colorectal cancer analyzed to date, two of which had confirmed Kras mutations in codon 12.
The prognosis for patients diagnosed with colorectal cancer at the localized stage is good with a five-year survival rate of 91%, however only about 39% of cases are diagnosed at this stage; five-year survival rates drop to 70% with the spread to adjacent organs or lymph nodes and 11% for distant metastases. Colorectal cancer is the third leading cause of cancer death among both men and women in the United States.
Oncolytics’ goals reach beyond the treatment of colorectal cancer; the company’s clinical program currently includes a variety of human trials, including a Phase III trial in head and neck cancers involving REOLYSIN.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. REOLYSIN preferentially replicates in cancer cells that have an activated RAS pathway. Approximately two thirds of all cancers have an activated RAS pathway, including most metastatic disease. A large number of mutations, including mutations in EGFR, Her2 or Kras along the RAS pathway lead to RAS pathway activation. For further information about Oncolytics, please visit: http://www.oncolyticsbiotech.com.