Avid Bioservices Inc (CDMO)

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An early first look-in at the SUNRISE trial would be an important, and conservative, tactic by Peregrine to protect the integrity of the accumulating trial data for the company, investors and the patients involved in the trial. I believe that the data should be examined at the earliest point where results would be mature enough to reflect safety for treated patients, integrity of the differential arms, and some TME analysis of interim data.

I’m not sure that, if that all is well at the first look-in, that the company will issue any PR. If a problem of safety or trial integrity were to be uncovered, I would expect that a PR would then be issued. Bavituximab has been used to safely treat hundreds, approaching 1000 patients now. That good safety is something that sets Bavituximab well apart from the downstream immunotherapies.

It is possible that the first look-in has already occurred, is in progress, or is upcoming soon? This, IMO, is the approach that Peregrine will take in monitoring this important registrational trial.

If all is well with the first look-in, the second look-in should be powered to stop the trial for an early move forward toward FDA approval. The primary endpoint for the trial, mean overall survival, if reflective of phase 2 performance, should start to consolidate around (+ or -) 6 months for the docetaxel arm, and (+ or -) 12 months for the Bavi treatment arm. We are again looking for a doubling of survival for Second-line NSCLC patients along with the continued safety that has been established with Bavi.

I think it is significant that Peregrine protects interim details for SUNRISE, as we move toward the scheduled full enrollment in this calendar year.

CP QUOTE:

“I start to find it suspicious that we do not get enrollment progress and/or possibly even end of enrollment PR's.”

QUOTES: JOE SHAN, July 14, 2014: Q4 FY 2014 CC speaking about the SUNRISE trial:

“...two planned event-driven interim data analyses.”

“We’re not going to comment on enrollment patterns or any specifics...”


Initial SUNRISE PR:

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=816379

SUNRISE trial:

https://clinicaltrials.gov/ct2/show/NCT01999673?term=bavituximab&rank=3


IMO

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