In looking at the timeframes on clinicaltrials.gov for the P2 and P3 trials that are currently in progress, I noticed that the estimated primary completion date for the randomized P2 trial for OGX-427 in prostate cancer is March 2011:
Estimated Enrollment: 72 Study Start Date: September 2010 Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Even though the primary endpoint is the proportion of patients without disease progression after 12 weeks, it's hard to believe they could enroll the patients that quickly. Does anyone have any thoughts on how seriously we should take the estimated primary completion dates on clinicaltrials.gov?
By comparison, here are the timeframes provided on clinicaltrials.gov for the other trials:
SYNERGY TRIAL FOR OGX-011: Estimated Enrollment: 800 Study Start Date: October 2010 Estimated Study Completion Date: January 2014 Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
SATURN TRIAL FOR OGX-011: Estimated Enrollment: 292 Study Start Date: March 2010 Estimated Study Completion Date: June 2013 Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Phase 1 bladder trial for OGX-427: Estimated Enrollment: 36 Study Start Date: July 2009 Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
FWIW the website for the Vancouver prostate cancer center, where the P2 prostate trial and the P1 bladder trial for OGX-427 are being conducted, lists the bladder trial as ongoing but doesn't list the prostate trial among its ongoing trials:
A couple of other prostate trials are said to be "ongoing but no longer recruiting." That suggests to me that the 427 prostate trial may have not only completed recruitment but be close to completion. (The clinicaltrials.gov webpage says it's still recruiting but that page hasn't been updated since September.)
In any case, if the clinicaltrials.gov timelines have any merit at all, we will probably get results from the P2 prostate trial for 427 in the not-too-distant future and then have a long wait before we get any other results, such as from the P3 trials for 011.
That means the P2 results for 427 will take on a lot of significance:
1. Even though 427 targets a different gene and protein than 011, since they both use Isis's second-generation ANS technology I think a positive result will tend to increase confidence that 011 will work and that the P2 results for 011 weren't a fluke, and a negative result will have the opposite effect. Since the 427 trial is testing its use as a monotherapy, success would be especially reassuring.
2. The 427 prostate trial is aimed at a big market: castration-resistant patients who are not yet getting chemo. And as Cormack has stressed, since 427 is designed to target the androgen receptor, it should work hand-in-glove with agents that reduce androgen production such as abiraterone and MDVN's agent (I forget the number).
So if the 427 trial is successful, OGXI will have to face the question of whether to partner it in order to fund a P3 trial (as well its use in other indications besides the randomized bladder trial they plan to fund themselves). I can't see how any partnership deal, which they've said they're exploring but aren't sure they want to pursue, could be completed before the P2 prostate results are in.