Replies to post #113389 on Avid Bioservices Inc (CDMO)

[cjgaddy]

Come on Peregrine, update the Factsheet again, and chg. it to H2’2013! Just kidding – I’m very happy with the progress they already given us.

Here’s the progression of “Median OS Data” event estimates for Front-Line NSCLC:
• 7-18-2012 Factsheet had Front-Line NSCLC MOS Data est. at H2’2012.
• 9-12-2012 Factsheet chgd. Front-Line NSCLC MOS Data est. to Q4’2012-Q1’2013.
• 1-31-2013 Factsheet chgd. Front-Line NSCLC MOS Data est. to H1’-2013.

So, we’ve gone from H2’2012 back in July to H1’2013 today.

= = = = = = = = = = = =
By: Freethemice 2-22-13 iHub #113252 http://tinyurl.com/aqby4zl
I added another trial to the table (18 now) and the Peregrine results for comparison.


G. Phase IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402
...FTM's Table of 18 prev. Ph.3 Trials in 1st-Line NSCLC, MOS results (CTL: 7.7-12.7mos.,mean=9.8, TREAT: 8.1-13.4mos.,mean=10.1): http://tinyurl.com/aqby4zl
...3-9-12: Topline ORR & PFS Data (Bavi+PC vs.PC-only) http://tinyurl.com/7m9r6ya
…...LOCAL reads: ORR/32%-31% PFS/5.8-4.6mos , CENTRAL reads: ORR/25%-23% PFS/6.7-6.4mos
...12-6-11 Prelim. Data (n=86, 100% Stage IV's) => ORR=39%, PC/alone=25%: http://tinyurl.com/7ph4tty
......Comp. vs. Avastin+PC/Ph3/n=417(74% Stage IV's): ORR=35% (Sandler/E4599/2006 http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884 )
...9-8-11: Enrollment complete. http://tinyurl.com/3vv9zfx
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as
…7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab."
...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl
……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.

Peregrine’s Corp. Fact Sheet updated 1-31-31 - “Feb. 2013”:
http://www.peregrineinc.com/images/stories/pdfs/2013-01-31_corp_fact_sheet.pdf

Advancing Clinical Pipeline with Multiple Near-Term Inflection Points (Feb. 2013):