Oncolytics Biotech Focused on Development of Oncolytic Viruses

Oncolytics Biotech Inc. is focused on the development of oncolytic viruses for use as cancer therapeutics. The Company’s lead product, REOLYSIN®, a proprietary formulation of the human reovirus, is currently in late stage (Phase III) clinical testing in head and neck cancers.REOLYSIN® has been utilized in nearly thirty clinical trials including translational, Phase I, Phase II (single arm and randomized), and Phase III studies in a broad range of cancer indications.

Head Office:
Oncolytics Biotech Inc.
210, 1167 Kensington Crescent NW
Calgary, AB, Canada
T2N 1X7
Telephone: (403) 670-7377
E: info@oncolyticsbiotech.com
W: www.oncolyticsbiotech.com

Mechanism of Action
The reovirus, or Respiratory Enteric Orphan virus, has been demonstrated to replicate specifically in tumor cells that have a constitutively activated Ras pathway. Activating mutations of Ras and mutations along the Ras pathway occur in approximately two-thirds of all tumors. Tumors bearing an activated Ras pathway are deficient in their ability to activate an anti-viral response mediated by the host cellular protein, PKR. Since PKR is responsible for preventing reovirus replication, tumor cells that lack the activity of PKR are susceptible to reovirus infection and eventual cell death. As normal cells do not possess Ras activation, these cells are able to thwart reovirus infection by the activity of PKR. In a tumor cell with an activated Ras pathway, the reovirus is able to freely replicate and kill the host tumor cell. Progeny virus particles are then able to infect and kill surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until there are no longer any tumor cells carrying an activated Ras pathway available.

Manufacturing
REOLYSIN® is currently being manufactured under a commercial supply agreement with SAFC, a Division of Sigma-Aldrich Corporation. SAFC will manufacture all necessary product through the completion of clinical testing, as well as commercial product subject to the receipt of regulatory approval.

Intellectual Property Portfolio
To date Oncolytics has been issued over three hundred patents worldwide, including the US and Canada, and has more than two hundred pending applications. Issued patent claims pertaining to the reovirus cover:

• Compositions of matter comprising reovirus
• Pharmaceutical use of reoviruses to treat neoplasia and cellular proliferative diseases
• Combination therapy with radiation, chemotherapy and/or immune suppressants
• Methods for manufacturing reovirus and screening for susceptibility to reovirus
• Pharmaceutical use of reoviruses in transplantation procedures

The Market
The American Cancer Society estimates there will be more than 1.6 million new cancer cases diagnosed in the United States alone in 2012; more than 1,500 people a day are expected to die from the disease. The US National Institutes of Health (NIH) estimates that in 2007 the direct medical costs (total of all health expenditures) associated with cancer were in excess of $100 billion.

To date, REOLYSIN® has shown activity in a broad range of cancers. Oncolytics is currently conducting clinical trials in six of the ten most common cancers diagnosed in men and five of the ten most diagnosed in women.