Avid Bioservices Inc (CDMO)

[cjgaddy]

The Ph2/n=120 2Line-NSCLC Trial basically doubled MOS ~6=>~12mos prior to the CMS screwup found in the CTL & 1Mg arms forced Peregrine to combine the 1Mg & CTL arms for comparison with the CMS-untouched 3Mg arm for “Final Data” and FDA approval to proceed with Ph3 SUNRISE. Note that the 9-7-12 interim data (showing stat-sig. doubling of MOS) reported just before CSM Ctl/1mg screwup was found/reported would have been EVEN BETTER had the CTL (DoceOnly) arm not received ~25% of BAVI and the 1Mg arm hadn't received ~25% of DoceOnly...

I. Just Before the CSM CTL<=>1Mg Screwup was found/announced (3mg OK)...
...9-7-12: PPHM PR (& Slides) about Dr. Gerber's plenary at ASTRO/Thoracic/Chicago (INTERIM Ph2 NSCLC Data): http://tinyurl.com/96wrrso
…”The interim data showed a statistically significant improvement in OS (Hazard Ratio 0.524, p-value .0154) and a doubling of MOS (12.1/13.1mos. vs. 5.6mos.) in the Bavituximab-containing arms compared to the [Docetaxel] ctl-arm."
......VP Joe Shan's 15min. Webcast & Slideshow recapping Dr. David Gerber's 9-7-12 ASTRO/Chicago Plenary: http://tinyurl.com/96wrrso
…9-10-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/8nkwrml )
……"The Ph2 NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Ph2 trial that provided these robust data and that provide the basis for us to plan for a pivotal Ph3 pgm."
- - - - - ->Ph2 Interim B4 CMS CTL/1mg Screwup found:
DoceONLY n=38: ECOG0-1-2=25%-62%-13% MOS=5.6mos.
Bavi/1mg: n=40 ECOG0-1-2=45%-43%-12% MOS=11.1mos.
Bavi/3mg n=39: ECOG0-1-2=20%-56%-24% MOS=13.1mos.
***FOUND OUT LATER: ~25% of CTL had 1mg, and 25% of 1mg had CTL(DoceOnly). Ie, CTL arm was HELPED and 1mg arm was HURT. Ie, Results would have been even better w/o CMS screwup. Also, note 3MG Arm had a hurdle of more ECOG=2 pts (24%).

II. FDA APPROVED SUNRISE AFTER PEREGRINE COMBINED DATA IN CTL & 1MG ARMS DUE TO CSM SCREWUP:
6-3-13/ASCO’13: Final Data Ph.II 2L/NSCLC http://tinyurl.com/my8qxw7
…60% improvement in MOS: Bavi/3mg=11.7mos. vs. 7.3mos. for CTL-arm(combined Bavi/1mg + DoxyOnly arms), HR=.662, P=.113
=>ECOG=2: Combined-Placebo+1mgBavi: 12.5%, 3mgBavi: 24.4%

= = = = = = = = = = = = = = =
ECOG: Ph3SUNRISE/0-1, Ph2Bavi+Doce(n=120)/0-1-2, Ph2Bavi+Durva(AZN)/0-1, Ph3Herbst2010/0-1 (2L/NSCLC)
0=FullyActive, 1=CompletelyAmbulatory/NoStrenuous, 2=Symptomatic/<50%inBed@Day/NoWork, 3=>50%inBed@Day/LimitedSelfCare, 4=CompletelyDisabled
http://radiopaedia.org/articles/ecog-performance-status

6-2012: FTM's charts of MOS Data from CtlArms(chemo) of Comp.Trials for 1NSCLC 2NSCLC PANCRE trials http://tinyurl.com/757plm7