Biotech Values

[microcapfun]

>>Microcapfun
It might take you about 15 minutes to scan their results in the 15 yrs or so and you might see that results are there for somebody to see ... Making disparaging comments without actually doing some reading shows how intellectually lazy you have become.<<

Fair enough - though if you hadn't been repeatedly pumping the company on this board I would have kept my intellectually lazy mouth shut.

I went through their investor presentation slides.
http://www.oncolyticsbiotech.com/pdf/ONCY_Investor_Presentation_Oct_21_2010.pdf
Their main justification for going to Phase 3 in head and neck cancer is given in slide 4 in which they claim 8 PRs out of 23 patients in a single arm trial of reovirus + paclitaxel. This is a 35% RR using intent-to-treat, but (surprise, surprise) they throw out 4 patients and write the RR as 42%. Paclitaxel exhibits responses in this indication, and with such a small number of patients, it could well be generating all 8 of them. But the real question is whether median survival increases by adding reovirus to paclitaxel. Amy serious biotech company would carry out a Phase 2b randomized trial with ~200 patients and an OS or at least PFS primary endpoint before going on to Phase 3. Not only would that be perfectly ethical, but going on to Phase 3 w/o doing it is *not* ethical. Instead Oncolytics compares to *historial* median survival data and writes "8+ months (mean, 4 pts still alive)".

Of course mean is not median so there is no comparison; the mean can be much larger than the median due to even one patient who got lucky and lived a long time. They are purposely hiding the median in that trial, which is likely <<8 months and therefore totally unimpressive for this disease - depending on which handpicked patients they put in their 23 patient non-randomized trial.

So red flags and spin all over the place.

If you go back to the old Phase 1 & 2 results in head and neck cancer from Onyx (oncolytic viral therapy) and Introgen (gene therapy), you will see that they had an order of magnitude more Phase 1/2 data - yet both failed to get close to registration.

So while I admit I haven't studied Oncolytics to death, color me totally unimpressed. It looks like a typical hype biotech company to me (which is the conclusion I arrived at many years ago), milking investors for as long as possible with spin and half-assed data just like Introgen did.

It's O.K. if you disagree. But with all due respect, I don't have any desire to discuss the company further - at least not until their Phase 3 fails.

micro