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Oncolytics Biotech Inc. (ONCY), Calgary, Alberta, Canada, has been advancing REOLYSIN(R), an innocuous RNA reovirus, as a treatment for cancer since 1998. Reovirus enters human cells but does not replicate in normal cells.

However, reovirus infection in malignant or cancerous cells containing an activated Ras signaling pathway, results in production of progeny virions until they burst the cell membrane or kill the cell. Released progeny then infect and replicate in other cancer cells repeating the oncolytic process.

On 3/20/09, Oncolytics announced positive results of a Phase I/II Trial of patients with advanced head and neck cancers after treatments with REOLYSIN(R) combined with paclitaxel/carboplatin. For patients with this degree of disease and treated with platinum agents, the response rate (partial (PR) and complete response (CR) rate is generally in the 3% -10% range relative to the 42% response rate observed for the REOLYSIN combination group of 12 evaluable patients in this ongoing trial. The clinical response benefit rate (CR + PR + SD [Stable Disease]) is 75%. Also announced was an update of a combined REOLYSIN(R) and docetaxel clinical trial for patients with advanced cancers being conducted in the U.K. Of the 17 evaluable patients, 15 of the 17 experienced SD or better with a clinical benefit rate of 88%.

These heavily pretreated patients are very difficult to treat and thus this objective benefit is encouraging. Treatment with REOLYSIN(R) causes only minor cold-like symptoms. REOLYSIN(R) is a reovirus (Respiratory Enteric Orphan virus) which is a is a ubiquitous double-stranded RNA (dsRNA) highly stable unenveloped icosahedral capsid virus. There is no known illness associtated with reovirus infections in humans. Reovirus is found ubiquitously in the environment such as water and sewage and as many as 50% of adults have been exposed and carry antibodies against the virus. More than 80% of human tumor cell lines have proved to be infectable by reovirus.

Currently, Oncolytics is conducting nine Phase I/II or Phase II clinical trials in the U.K. and U.S. There is a collaborative agreement with the National Cancer Institute in the U.S. to conduct multiple clinical trials. Oncolytics has demonstrated commercial scale production of REOLYSIN(R) and has a strong intellectual property position. Since the founding of Oncolytics in 1998, by researchers who studied the virus at the University of Calgary, the stock has traded up to $8.45 a share but is currently $1.31. Research with cultured cells, grafted and excised human tumors have shown that REOLYSIN(R) in combination with tested chemotherapeutic or radiation treatments have been synergistic compared to the individual treatments. Oncolytics has advised that it has decided to conduct it’s pivotol Phase II/III randomized clinical trial of head and neck cancers with REOLYSIN(R) in combination with paclitaxel and carboplatin. From it’s beginning, this company has and is focused on REOLYSIN(R) while increasing it’s knowledge of reovirus replication and synergism with chemical and radiation treatments in cancerous cells. There are many companies that have attempted to alleviate the suffering of those with cancer, but relatively few succeeded in commercial products that destroy cancer cells without serious side effects.

The evidence to date, based on published scientific experiments and initial clinical trials, favors that Oncolytics will suceed in their pivotal clinical trial. In a rational world, it is hard to imagine that a cancer therapy, which selectively kills cancer cells while sparing normal cells and results in minimal side effects, and most likely at reasonable cost, would not eventually gain approval as an additional therapy to assist in controlling or eliminating cancer, either as a monotherapy, or synergistically with chemotherapeutic drugs and/or radiation therapy.

Disclosure: Author holds a long position in ONCY

Source: Pivotal Cancer Treatment: Oncolytics Likely to Succeed