Oncolytics Biotech Inc. (ONCY)

[onco_investor]

Oncolytics ready for final step with Reolysin

(Note the new details of partnership plans by geographic region with Western EU and US being first. What is expected to drive partnership I believe is NSCLC RAS+ results due later this tear. Dr Thompson expects that a partnership should happen in the next year timeframe. Also initial Phase III first 80 patients enrollment is hoped to be by Christmas and initial results are expected by mid-2011)

May 18, 2010 by leonardzehr BioTuesday.ca

http://biotuesday.ca/2010/05/18/oncolytics-ready-for-final-step-with-reolysin/

After a 10-year journey, Oncolytics Biotech (TSX:ONC (2.81 ?0.00%); NASDAQ:ONCY ) is ready to take the final clinical step with its sole Reolysin drug as a treatment for a broad range of cancers.



“Our product has really shown a breadth of activity in a wide variety of cancers that we had hoped it would way back when we started out,” CEO Dr. Brad Thompson said in an exclusive interview with BioTuesday.ca. “It doesn’t matter what kind of drug combination we use or the amount of radiation, we typically get a clinical benefit no matter what the indication is, which is honestly pretty remarkable.”

Since 2000, when Reolysin first entered the clinic, Oncolytics has enrolled some 330 patients in multiple Phase 1 and 2 studies. “When we lump all indications together, you see this pattern, where people have a three-in-four chance of stabilizing or having a tumour regress fairly significantly. And an even higher percentage in metastatic lesions,” he adds.

The company is now gearing up to start its first Phase 3 pivotal study with Reolysin in patients with advanced head and neck cancer at 25 centres in Britain and the U.S., under a special protocol assessment from the FDA, with plans to expand to Belgium, for multijurisdictional approval in Europe and Canada.

Reolysin will be tested in combination with two chemotherapy drugs, paclitaxel and carboplatin, versus chemotherapy alone in a two-stage clinical trial. The first stage is designed to enrol 80 patients. The second stage is adaptive, and designed to enrol between 100 and 400 patients, with the most probable statistical enrolment now being 200 patients, Dr. Thompson explains.

The company expects to complete enrolment of 80 patients by this Christmas and release some initial data next spring or summer, he adds. The primary endpoint is overall survival, with key secondary endpoints including progression free survival, response rate and duration of response, as well as safety.

The U.S. National Cancer Institute estimates that 48,000 people in the U.S. alone contracted head and neck cancer in 2009 and that 11,260 died. European incidence and mortality are substantially higher than in the U.S., standing at 140,000 new cases each year and 69,000 deaths.

The decision to pursue a Phase 3 trial in advanced head and neck cancer followed positive results in mid-stage testing in Britain, combining Reolysin with paclitaxel and carboplatin, where the company demonstrated an overall response rate of 42% and a total clinical benefit rate of 74%. The company is currently conducting a confirmatory Phase 2 trial in the U.S. with patients having the same disease.

So what gives Reolysin such high marks?

Reolysin is a formulation of human reovirus, an acronym for respiratory enteric orphan virus. While the reovirus occurs naturally in nature, it is not known to cause any disease in humans. Its cancer-killing link comes from its ability to reproduce in various cancer cells that have an activated Ras pathway, one of the most important genetic defects leading to cancer.



In normal cells, the Ras pathway is turned off and the reovirus is unable to reproduce, creating few consequences for normal cells. Not so in cancer cells though, where an activated Ras pathway leads to a constant barrage of uncontrolled growth signals.
The company estimates that at least five million new patients a year will develop cancers with Ras involvement.

Dr. Thompson acknowledges that Reolysin works better in combination with chemotherapy or radiation than it does as a monotherapy, even though animal studies generated a strong response rate when Reolysin was used alone. “When we first started doing monotherapy in humans, the response rate dropped in half,” he recalls.

Further research found that by ablating the immune system with chemotherapy or radiation, channels opened in the cell wall of tumour cells, reducing the pressure within the cell. That allows the reovirus easy access into the cell, where it reproduces and kills the cancer cell. As cell death occurs, thousands of virus particles are released 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.

“We assumed that we would be able to mimic in humans what we saw in animals with monotherapy,” he recalls. “We developed a good database, but it added three or four years to our timelines. It was a worthwhile diversion, because we now know how the product works. In the end, it’ll probably be a normal 13- to 14- year lifecycle to get Reolysin into people.”

Last January, Versant Partners initiated coverage of Oncolytics with a “buy” rating and price target of $4.25. Analyst Doug Loe writes that his model assumes pivotal head and neck cancer testing will conclude by the second half of 2013, with FDA approval obtained 12 months later and Reolysin launched in the first half of 2015.

Oncolytics has concluded 12 human clinical trials with Reolysin. Besides head and neck cancer, Reolysin is being studied in multiple early- and mid-stage settings by the NCI and by Oncolytics in a variety of advanced malignancies.

Mr. Loe points to Phase 1/2 Reolysin trials on pace to report data in 2010-11, including: a 52-patient metastatic sarcoma trial; a 44-patient brain cancer trial; a 36-patient lung cancer trial; and a 43-patient metastatic melanoma trial.

Analyst Neil Maruoka of Canaccord Genuity says in a new report that Phase 2 lung cancer data, expected later this year, is of “particular importance as it may be a trigger for a partnership with Big Pharma.”

Dr. Thompson acknowledges partnering is being pursued and that “we would expect to have a partner in place in the next year” to create a “long-term, measurable benefit for shareholders.” His strategy is to partner by geography, targeting Western Europe and the U.S. initially. That would be followed by Asia, the Far East and the rest of the world. “Depending on how talks progress, we could potentially have up to four partners by regions.”