Oncolytics Biotech Inc. (ONCY)

[onco_investor]

Randomized Phase II NSCLC Announcement Webcast
Partial Transcript

Thanks to RJC for transcribing this Webcast.

June 5, 2012 Conference Call "Randomized Phase II Conference Call"
Audio: http://podcast.newswire.ca/media/oncolytics20120605.mp3
PR: http://www.oncolyticsbiotech.com/news_items/details?press_release_id=1892

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{1:40} Brad: This morning we announce that Oncolytics has entered into an agreement with the NCIC CTG to sponsor a randomized Phase II Study in second line NSLC. The study will enroll approximately 150 patients …

{2:30} To date, the single arm non-squamous NSCLC Study [REO-016] has demonstrated a Disease Control Rate (which is Stable Disease or better) of 89%, and the single arm Squamous Cell Carcinoma Study [REO-021] has demonstrated a Disease Control Rate of 82%. These are approximately twice the Clinical Benefit Rates [=Disease Control Rate] reported for paclitaxel treatment for similar stage NSCLC patients …

{3:25} Today's announcement brings the total sponsored studies in our clinical portfolio to 8, 5 of which are randomized Phase II Studies. Now that we have finished enrollment for the first stage of our Phase III H&N Clinical Trial, these additional randomized Studies will help us determine where to focus our future Phase III Clinical Trial program. …

{3:55} The 5, third party sponsored, randomized, Phase II Trials in our portfolio are expected to enroll approximately 520 patients. It would cost Oncolytics approximately 42 million dollars to conduct all 5 randomized Studies on a non-sponsored basis. However, with the sponsorship of the NCI and NCIC, our total contribution to these 5 Trials will total around 6 million dollars, some of which will be payable from resources that Oncolytics already has in hand.

{4:55} Question from Alan Ridgway – Paradigm: Brad, maybe just a little bit more detail on the design of the Trial. Is there a cross-over with patients on the control arm at all?

Brad: No, there is not. We felt in this particular Study that it was better to stick with pure PFS as the primary end point.

Alan: As far as the non-squamous running with pemetrexed, have you guys run any Studies with this before, and is there going to be a run-in of any kind going into this Trial"

Brad: There'll be a 6 to 9 patient run-in on the pemetrexed arm just to make sure that everything is ok with that particular drug combination. It is our first time using that combination. Pemetrexed is a simpler disease treatment regime here in Canada than it is in the United States, which is part of the reason we chose to run the Study here. The use of pemetrexed is really common in that particular stage, for that particular indication.

Alan: And do you guys believe that pemetrexed will give the same sort of benefits that carbo/tax does in the Trials that you've run to date?

Brad: Yes … based on the information that we have, it should run pretty much the same. The choice of second line is interesting because I would think that further Studies with the carbo/tax combination (which we're still contemplating) would back up into first line again. So I think you could potentially see having two separate lung programs, running one in first line and one in second line, but we're focusing on the second line first.

Alan: The Clinical Benefit Rates that you quoted in your prepared statement of 89% and 82% … how many patients have been enrolled in those two Trials now? What's the patient size that we're talking about for those two numbers?

Brad: That's still evolving. We're, I think, just a patient or two short of finishing the primary enrollment in the NSCLC Study in the States, and the squamous cell lung study is in behind that, so those numbers are around 60ish patients and that's still evolving upwards as we speak, so I think we're getting a pretty good handle on the magnitude of difference. If we were looking at going from 40- 50% to 50- 60% Stable Disease or better, I don't think I'd be visually impressed or enthused, but getting up into the 80's, the high 80's on those two separately is potentially significant.

Alan: And that's 60 patients combined; right? … about 30 patients in each?

Brad: Yes … that's about right.

{8:10} Question from Neil Maruoka – Canaccord Genuity: In regard to some of the previous Studies that you put out, you announced the non-small cell Study last year; if I recall, you haven't talked too much about the SCC [REO-021] Study, but has the data you have gleaned so far from the study … does that impact on the design of this Trial, and does it impact what lung cancer indication you might move into going forward?

Brad: I think it's a fairly complicated Study evolving … particularly looking at EGFR mutation, EGFR over-expression, and KRas mutation status, in these patient groups; and a further reason we're proceeding cautiously with this is because we're actually seeing some interesting patterns emerging that are a little surprising. For example, in the non-small cell lung study that we've already previously reported a little bit of the detail on, and you're seeing a very high correlation with Stable Disease or better with KRas, but you actually get a higher Response Rate based on some interesting differentiations ... with EGFR status, but a lower Clinical Benefit rate.

So you're seeing differences within the supposed all Ras pathway activated populations based on these different markers. I want to see that data mature to get some differentiation on that. Now, that one piece of data alone has influenced not just these Studies' design, but all our Studies' design going forward. We're having a much heavier emphasis on correlative work looking at those three particular elements. For example, our colorectal Study that we're about to initiate enrollment in has those correlative elements, the prostate Study has some of that, we're already doing that in some of our other Studies; and I think in the end, that's really going to be the key about where Reolysin is going to find its home as it were. So yes, those Studies have really heavily influenced not only the design of these Studies, but other Studies as well.

{10:30} Neil: any timing on when we can expect to see data from the lung or the squamous cell study?

Brad: I'm not sure on the defined date for the squamous cell Study. For the non-small cell lung Study, I expect to have enough data in a meeting sometime in the near future. We've a pretty mature data set and the investigator is basically just selecting a time that he would like to present it. The squamous cell is really turning into an interesting Study for a very different reason … out of all the minor tumor responses and partial responses that we've seen, we haven't to date, yet, seen any of the kind of weeping side-effect issues that other Studies have reported for similar responses. We're focusing very heavily on making sure we evaluate that particular component separately, so we'll just grind through that, and get it out when we get it out.

It is interesting that we're seeing very similar Stable Disease or better rates between these two patient populations, albeit in relatively low numbers, because you see quite different responses in other Studies when you actually compare squamous to non-squamous. Reo in combination appears to … consistently … whether you're talking radiation, or with taxanes, or with taxane combinations, or platinums … you get this very typical 80% to much higher than 80% Stable Disease or better rate, pretty much regardless of the primary indication. It's interesting. Dealing with that in randomized studies is what we're dealing with now, but it is interesting that you're actually starting to see this pattern, at least on the Clinical Benefit side, that kind of transcends the primary indication.

{12:40} Question from Philippa Flint – Bloom Burton: Can you just talk a little bit about your potential options for a strategy going forward. I expect data on the Head & Neck Study soon, but how do you look at the other indications in terms of when you get pancreatic data, the non-small cell, what are your options for next steps in terms of either positive or … regardless of the data from Head & Neck?

Brad: Thank you for asking that, because that's the critical question for company at this point and time. I don't have any idea what's going on with the data of Head & Neck … I mean, I'm as blinded as everybody else on the planet, in that analysis is just going on independent of anybody inside Oncolytics. So, when the data comes out, the data will come out, which (for people that know me, and know my curiosity about things), as you might imagine how that is affecting my psyche at the moment, but that's a completely different discussion.

You have to initiate two paths. Path A is the Head & Neck looks great, and we continue on and finish the Study, and we go down that path, and that's a good path. And on that path, you always have the question of what's next. We've tried to be as diligent as we can in moving Reolysin into other randomized indications where it makes sense scientifically, and now that we have 5 randomized Phase II Studies ongoing, I think that that's answered that question.

The flip side is that if the H&N Study, for some reason isn't as positive as we all hope, and it can … that happens in oncology, people pick different indications, and sometimes they pick the wrong one first, but the key for us has been to have the resources in-house to proceed on with this other randomized program, and we do. All these Studies that we've announced, because of the way we've structured the funding with the sponsorships, we already have the resources in-house to do these Studies regardless of what happens with the H&N program. So if you want to think of Plan B (if you want to call it that), Plan B is to carry on with randomized Studies that are rational from a scientific perspective to define Reolysin's home … to find the right home for it. So Plan A has you expanding use, and Plan B has you finding (in a randomized clinical setting) where the best place for Reolysin is, both being fully funded.

I think the first Phase II randomized data that's likely to come out will be the pancreatic Study in the States, which is carbo/tax vs carbo/tax/Reolysin, and that's an interesting Study in that we're not using Gemzar in first line patients.

But I think you can see a theme across all these clinical Studies that we're doing, is that there's a very heavy emphasis on metastatic disease, and that's the case there. Even primary pancreatic cancer which is all metastasized, or the primary colorectal Study which we'll be doing in Canada, virtually all the patients will metastasize. All the second line patients and further on, like the Ovarian Study are all metastasizing. You have this kind of theme of metastatic disease running through the whole program and I would think that the panc study will be the first Phase II Study to report out either on an interim or a final basis.

Philippa: And when would you expect that data?

Brad: We're just working through that right now. I don't have a specific date on that, and it's an evolving picture, and we're having discussions with the Investigator about when would be best to discuss the data. Again, there's a heavy emphasis on looking at the correlative bits, particularly the KRas in that indication. Again, there's a picture emerging, and it's really when we're comfortable with the picture … that is the time to talk about it.

< Close by Brad >

I'd just like to thank everybody for their time and attention this morning, and let everybody know that I would expect to see further evolution of this Phase II program, all these different randomized Studies, within these coming weeks and months. This is an exciting stage for the company to be in, to be actually spreading out in randomized Studies, to really definitively answer with respect to specific indications about whether Reolysin actually has the statistical evidence of being active in each one of these indications. It's been a long time coming, and we're delighted to actually be at this stage of development with the company.

So again, thank you, and hopefully we'll have another communication with you soon.

< end >

Transcribed by rjc