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Oncolytics Biotech Inc.

Drug Names(s): RT3D

Description: Reolysin, a proprietary formulation of the human reovirus, has been demonstrated to replicate specifically in tumour cells bearing an activated Ras pathway. Activating mutations of Ras and upstream elements of Ras may play a role in greater than two thirds of all human cancers.

Reovirus, an acronym for Respiratory Enteric Orphan virus, is generally believed to inhabit the respiratory and bowel systems in humans. Reovirus is found naturally in sewage and water supplies. By age 12, half of all children show evidence of reovirus exposure and by adulthood, most people have been exposed. However, the disease is non-pathogenic, meaning there are typically no symptoms from infections. The link to its cancer-killing ability was established after the reovirus was discovered to reproduce well in various cancer cell lines.

Tumours bearing an activated Ras pathway are deficient in their ability to activate the anti-viral response mediated by the host cellular protein, PKR. Since PKR is responsible for preventing reovirus replication, tumour cells lacking the activity of PKR are susceptible to reovirus replication. As normal cells do not possess Ras activations, these cells are able to stop reovirus infection through normal PKR activity. In tumour cells with an activated Ras pathway, reovirus is able to freely replicate and eventually kill and host tumour cells. As cell death occurs, progeny virus particles are then free to infect surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until there are no longer any tumour cells carrying an activated Ras pathway available.

Deal Structure: In February 2009, Oncolytics Biotech and the Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio, (CTRC at UTHSCSA) announced a broad preclinical and clinical collaboration involving up to five, open-label, Phase II studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications. These indications are expected to include melanoma, pancreatic cancer, squamous cell lung, liver and K-RAS mutated colorectal cancers in combination with standard chemotherapeutics.

In May 2011, Oncolytics announced that it has entered into 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.

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