the press release, but its hard for me to believe OGXI would be hosting an investigator panel at ASCO to review the OGX-427 data if it wasn't very positive. If a few analysts came out with some positive coverage then we could explode to the upside.
It's been many years since I last saw or read Hamlet but I'm sure the Bard would have been extremely flattered to see himself quoted so fittingly on a Yahoo board dealing with biotech stocks.
Anyway, 'tis true indeed that there's no way OGXI can do a P3 trial pairing 427 with MDV-3100 or abiraterone in any setting without first doing a P1 trial to show that the combination is safe. So I agree that that's what they'd have to do next, hopefully in the pre-chemo space if the FDA will let them do it before approving abi or MDV-3100 in that space. The path to approval may be long but the pre-chemo prostate market is huge so I agree that that's probably the way to go. Now all we have to do is wait a couple of weeks to see what they have to say about it.
>do you mean one that has survival as the primary endpoint.
That would be way too long. That's not what Cougar or Medivation did either. I guess the best we can ask is TTP in a P2 prechemo trial.
>Also, are you suggesting that the P3 trial they'll want to run will be in the after-chemo setting as the initial P3 trials for MDV 3100 and abiraterone were?
No. However, that's the right path. Cougar had P2 and Medivation had P1/P2 data in this setting before deciding to run a P3 trial. OGXI does not have such data. So I dont think they can run a P3 trial in a setting with no previous data.
>Maybe what would make the most sense would be to pair it with abi or MDV-3100 in the post-chemo space.
They cant do this (yet) as well. They dont even have a P1 trial (let alone a P2) in this setting.
>I would think they'd want to do one in the prechemo space, similar to what they're doing in the P2 trial.
Yes. I agree. It took me a while to reach this conclusion but this is the one that makes most sense now. If they have good data for the primary endpoint and even maybe some very early TTP data, maybe a good p value or promising HR, or something, why not? Yes. I think they'll cut to the chase and go for the jugular right away. I think/(hope?) that's why we have the panel. Or I might be laying that flattering unction to my/our souls as this might be my madness who speaks.
Summer, I'm a little confused. By "proper P2 trial" for 427 do you mean one that has survival as the primary endpoint, instead of progression at 12 weeks as the one they're presenting on does? Obviously as you say that would take a long time. As it is, they're not even waiting for the progression trial to be completed to present data but are presenting preliminary data (which is another sign that they think the data is good), so yes, they do seem to want to move quickly.
Also, are you suggesting that the P3 trial they'll want to run will be in the after-chemo setting as the initial P3 trials for MDV 3100 and abiraterone were? I realize that a trial like that would be the fastest to complete but I would think they'd want to do one in the prechemo space, similar to what they're doing in the P2 trial. That way, they'd get to pair it with MDV 3100 or abiraterone, which they've said, as I mentioned above, work in a complementary fashion with 427. I realize that MDV 3100 and abiraterone aren't yet approved in that space, so I suppose they'd have to wait until that happens before initiating the trial and then, as you say, the trial would take a long time because survival is being extended.
Maybe what would make the most sense would be to pair it with abi or MDV-3100 in the post-chemo space. I don't see them doing a post-chemo trial of 427 as monotherapy since it seems to work best as a combination drug, and I don't see them trying to replicate the 011 trial by combining it with chemo.
I agree. However, the question is why are they doing the panel?
I always assumed that the right thing to do for 427 is to run a proper P2 trial and then start a trial in the after chemo setting in mCRPC like Medivation or Cougar did before pushing to a P3 in prechemo. However, fortunately for the patients, unfortunately for OGXI, with so many available drugs that extend the OS before and after the chemo, the mCRPC trials are now very long trials.
So if the OGXI decides to run a proper P2 trial before deciding to run a prechemo P3 trial, it would also need to take the new mdv3100 (http://clinicaltrials.gov/ct2/show/NCT01212991) and abi (http://clinicaltrials.gov/ct2/show/NCT00887198) trials into consideration which are expected to extend OS even longer in the prechemo setting.
I dont think the co wants to take path. So I think OGXI will make a run for it with just this P2 trial, which is probably the right thing to do for the shareholders. Otherwise, if we wait longer, the approval of 427 in mCRPC might be 8-10yrs away.
I think that's why we have the panel much like the OGX-011 panel at ASCO 2.5yrs ago. The co will announce its intention for a 427 P3 trial in mCRPC.
With MDVN (a partnered drug) at $2B, I dont think they'll have any issue in finding a partner if the data is any good, which I assume it is somewhat OK. Otherwise why bother?
The data will be good but its very Early trial data as Dr: k stated.
So no proof of concept but 427 knock down drug potential will be on display.
The stock will get a pop .... how big?? its all about street buzz with in the biotech sector.
The stock is cheap given its enterprise value.
I am a little puzzled about the panel discussion. I was not expecting it. Last time OGXI did such a panel was 2009 ASCO.
The panel discussion must be primarily for the P2 OGX-427 trial in castration resistant prostate cancer and not for p1 bladder results.
I thought they will just PR the results and move on especially since this is not a co sponsored trial and the trial is still recruiting.
The P2 427 trial is for patients who have not previously received chemo. Much like the highly anticipated P3 abi and mdv3100 trials.
Is the 427 data on-par / better than the equivalent results shown in early abi or mdv3100 trials to warrant such a panel discussion? If not, why the discussion? Are the results good enough to require a discussion now so that they can partner it (and not to keep it to themselves as originally planned) so that it can move to P3 asap?
Agreed James, the question is how good is the data?
Phase II results have to knock the socks off or no one cares. Even if results are excellent, there is dead time to get the drug to market (that is if it is approved).
The special circumstances here is that OGXI has 011 racing to the finish line at the same time as 427 emerges. That is why the data is important. Are we a one drug or two drug company? Does the validity of 011 get enhanced in light of 427?
Anyone can convince one pretty woman to dance with them? But two at the same time? Magic!