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Re: exwannabe post# 259578

Wednesday, 03/23/2016 6:19:56 PM

Wednesday, March 23, 2016 6:19:56 PM

Post# of 346073

Search on "trial halted for futility" and look at the official corporate PRs. They almost always use wording similar to PHPM's SUNRISE halt.



Interesting, I have been looking at Phase II/III halts and have "NEVER" seen a company PR that said that respective company's active drug arm performed as expected: "bavituximab combination group is performing as expected.."

I'm amazed at the control arm results, performing as expected... which means Peregrines Phase III Sunrise would have been approved if it went up against ANY other Docetaxel placebo group from all past 20 years. I'm amazed at the control arm results from the Phase IIb NSCLC that would have also led to approval if it was not sabotaged. I'm amazed at Peregrines 1st line NSCLC with similar placebo arm outperforming historical norms.....

The decision to stop the trial was based on the recommendation of the study's Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study. The interim analysis showed that the bavituximab combination group is performing as expected according to the original trial assumptions in terms of overall survival, while the docetaxel group is dramatically outperforming overall survival expectations based on the original trial assumptions and as compared to recently published studies.

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=957281



I bet the DTRA is also amazed and let me take a guess: 95% of most don't realize what is currently being discovered within DTRA programs


"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline."
-- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!

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