Biotech Values

[onco_investor]

The Phase III ONCY H&N trial is Multijurisdictional

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50292028

As was posted from an BioTuesday.ca article linked above, new details have emerged as to the planned Phase III (which should be starting enrollment in the next month)

<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.>


It should be noted that some of the sites chosen have already been enrolling Reolysin clinical trials for some time so the ramp up to this trial should be very quick. I hear you about the US enrollment rates. Many Phase II trials for ONCY have taken much longer than expected because of that. This issue highlights the need for a partner who can leverage their resources to enroll faster. Too bad you have to give away the store to partner to early. ONCY is treading a fine line between going it alone through the first H&N Phase III but will need a partner to go the distance which they have indicated will most likely happen after interim NSCLC RAS+ data later this year. Given the Reolysin MOA being effective in RAS+ cancers ONLY I give this trial the best chance of success theoretically.

onco_investor