My understanding is that the company would report interim results after 25 "events" (a patient passing I believe) for this phase II trial. Is this still the case, or are they going to wait until primary completion which appears to be the end of 2011. No mention of interim results in their end of year PR regarding upcoming milestones.
Assuming that they still plan on reporting interim results, do you think that we are close to 25 events having occurred, as the trial started in June 2010, and nearly 10 months have passed? Not sure, but one would think that there would be 25 events for placebo arm (those getting just gem.) I would tend to think that there would also be a few events for th-302 arm as well as there are probably some failures. (Median OS for gem is about 5 to 6 months I believe)
I guess this is somewhat dependant on pace of recruitment but it looks like they are still on pace for completion in late 2011 so one would think that they have recruited and dosed quite a few patients. Makes me wonder what is happening...the results so far for the dose escalation trail were really very strong in pancreatic cancer.
The one big UNKNOWN is that it appears that those that are in the placebo arm and progress have the option to cross over. So there is the possibility that 25 events have not occurred because the cross over patients are responding to th-302 and are doing well. Maybe this is why we have had no interim efficacy updates so far.
I could be wrong but the longer we go without any interim results, could very well indicate that there is strong efficacy.
On a side note, what I really like about the company is that they have these ongoing dose escalation trails which gives us an idea as to the efficacy. This gives me a lot of comfort when they proceed to randomized trials. For example, I would think that the phase II trial for pancreatic cancer will have similar results to the ongoing phase I/II non-randomized trial. Median OS so far is 11.4 months which is really strong. (Keep in mind that the 11.4 months is for both the low and high dose of th-302. I bet that if you back out the low dose, OS is better for the higher dose group).
Likewise, the ongoing phase I/II for sarcoma have been very strong so far which one would think will be duplicated in phase III. They are not controlled trails, but there is quite a bit of historical data out there for pancreatic and sarcoma, so I do not think there will be any surprises.
I have been primarily in HGSI for quite a long time (was lucky and got in at 2.OO). Sold out, and I am hoping for similar run up for THLD in the next two years.
I did take a look at the abstract that forms the basis of the PR, and it does state that median PFS is 6.1 and median OS is 11.4:
This was based on 46 patients. Not sure if the the PR is only looking at 43 patients and is disregardng the 4 patients that were not RECIST tested.
Hard to figure out....
You are correct - I thought maybe in the Lazard discussion he had broken out the hi-dose, which would not be comparable to the full 43-patient stats, but that is not the case. He clearly says that PFS for the 43 patients was 6.4 (and then an extra month when you look at the hi-dose group) and that OS was 11.4 (not clear if this was all patients or just hi-dose). Either way, something changed - both presentations speak to the total patient population of 43, so maybe the Lazard stats were preliminary or mis-computed. Might be worth a call/e-mail to their IR group, just to see how they respond?
Not sure - is the Lazard webcast still available? I assume the PR you are referring to was the 1/24/11 - hard to figure how the median OS could go down from Nov to Jan if had not been reached in Nov?
I thought they mentioned at one point that they may have interim results available for ASCO in June - no announcement yet if they are presenting, but if they do, you can probably bet the results will be good. Because of the crossover potential in the trial, the primary endpoint is actually Progression Free Survival, not overall survival, so I'm not sure the "events" in the trial patient deaths - I think it is when the patient progresses? Either way, if the response rates from the Phase 1/2 trial hold up, you would think that this would be a slam dunk. Note that the clinicaltrials.gov site lists the primary completion date as August 2011, so you would think they would have some solid interim results by June for ASCO?
If the "event" is progression of disease it would seem that at this point with about half the patients dosed, you would have reached the 25 event trigger?
(I am hoping that stops are being taken out and there isn't something out there that we are unaware of...)
Tredleon it´s hard to understand why has PPS colapsed so brutally since last finance offering. I know the new issue of so many shares or dilution was extreme, but given the expected outcome of TH-302 and prospects of a p/3 triaL that will begin in june plus the p/3 for pancreatic with Elieson, isn´t it a bit to worry about actual PPS @ this levels? What´s your opinion, what could be so wrong?