I guess Teva did not want to take the risk (which is the right thing to do from their perspective). This means, the P3 NSCLC is delayed at least another year. This is a bummer for OGXI as, if I remember correctly, the commitment for the NSCLC trial was the sticking point on the negations with other partners.
Maybe in the meantime TEVA can start a second line P3 docetaxel + ogx-011 trial to honor the essence of the deal.
Not a bad suggestion at all. To quote from your post at the beginning of this thread:
"Maybe in the meantime TEVA can start a second line P3 docetaxel + ogx-011 trial to honor the essence of the deal."
And that's exactly what they're doing. I wasn't expecting this at all. I've always gotten the impression from Scott Cormack's remarks that the choice was between paclitaxel or a platinum drug, or possibly a newer lung cancer drug whose name escapes me, in the first line setting.
But it's nice to see that Teva is apparently going forward with a P3 lung trial without stalling until SYNERGY's results are known. I assume OGXI will announce the trial in their Q2 CC, which probably will be in August.
It's all very confusing but I'm going to take the statement in yesterday's PR that they expect to begin the lung trial in 2012 at face value. I don't think they put that in by mistake. And the fact that they haven't put out a PR about the P1 safety trial may mean that it's less important than it seems.
I could be wrong but that's my story and I'm sticking to it. Might as well start the new year on an optimistic note.
Well, the design could be affected if the safety trial shows that combining 011 with paclitaxel could be a problem. In that case they'd have to go with a different agent.
In any case, the clinicaltrials.gov listing for the P1 safety trial says the trial is expected to be completed in December, 2012. That's why I have trouble understanding the statement in today's PR that they plan to begin the P3 trial in 2012. Maybe they're confident enough that the P1 trial won't disclose a safety problem that they plan to do all the prep work for the P3 trial while the P1 trial is being conducted.
Today's PR regarding publication of the P2 results for 011 in NSCLC includes the following sentence:
"Plans are underway for Teva and OncoGenex to initiate a Phase III clinical trial of custirsen in NSCLC expected to begin in 2012."
Not quite sure how to reconcile that with the initiation of the PK/PD trial discussed above but it sounds reassuring. I guess we'll have to wait until the next CC for an explanation.
Ugh! Not a cheery way to end the year. A trial that was supposed to begin in early 2011 is now delayed until at least 2013.
I too recall Cormack saying at the time of the deal that Teva's commitment to do the NSCLC trial was a big reason OGXI went with them. It will be hard now for him to convince investors that Teva isn't just stalling until it can get a handle on whether the SYNERGY trial will succeed. According to clinicaltrials.gov that trial is open label (http://clinicaltrials.gov/ct2/show/NCT01188187?term=synergy&rank=2), though I think Cormack has said that while the investigators aren't blinded OGXI and Teva are. Even so, you have to think Teva will have a sense of how it's going by early 2013 even if nothing happens at the time of the interim analysis.
What also fuels my skepticism about Teva's motives is that the FDA didn't require a P1 trial examining the pharmacokinetics before approving the expansion of the prostate SATURN trial to include another taxane, cabazitaxel. So why is Teva so worried about paclitaxel? (Of course, I don't know the science, maybe there is a problem that showed up.)
I see that the new trial will examine the pharmacokinetics of 011 with not only paclitaxel but also carboplatin. That implies they won't just go ahead with a P3 trial that mirrors the P2 combination of 011 with gemcitabine and either carboplatin or cisplatin. I don't recall OGXI saying Teva thought there was or might be a PK issue with platinum agents when it first announced the delay. I believe the reason given for not going ahead with a replica of the P2 design was that paclitaxel is more widely used in Europe whereas the gem/platinum combo is more common in the U.S. (or maybe it was the other way around).
I certainly hope Teva steps up and does something to honor the spirit of the deal, either by doing a P3 second line lung trial using docetaxel as you suggest or by initiating another prostate trial in combination with MDV-3100 or something else. I'm not feeling very optimistic at the moment though.
I'm not a TEVA fan. I personally believe that OGXI would have been better off picking almost anyone but TEVA. TEVA is for TEVA and they sometimes are too cheap IMO, and I personally don't trust them on anything. t
FWIW a redacted version of the OGXI-Teva license agreement is available online:
There are references to the clinical plan, including an "expected" initiation of the lung trial in 2011, on pages 39, 41, and 57. Teva has certain outs which are a little opaque to me. I doubt that they're in breach since they are proceeding with steps that seem preliminary to eventually initiating the trial, and even if they were in breach it probably wouldn't be productive for OGXI to make an issue of it since the prostate trials are moving forward.