Avid Bioservices Inc (CDMO)

[cjgaddy]

8-4-11: Per ClinicalTrials.gov, 13 new sites added in the ongoing Bavi+CP Frontline NSCLC trial, 28->41 sites (17 U.S., 24 Intl). That’s now 41+37=78 total sites for the 2 Ph2b randomized NSCLC trials.

G. PHASE IIB BAVI+CP VS. FRONT-LINE NSCLC (RANDOMIZED, UNBLINDED, 'CONFIRMATORY')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 8 RussianFED + 5 Ukraine = 41 of 8-4-11)
...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402
...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.
Site Growth:
• 10-11-10: 7US/0India = 7
• 11-8-10: 8US/5India = 13
• 11-23-10: 12US/6India = 18
• 12-6-10: 12US/7India = 19
• 12-20-10: 13US/7India = 20
• 12-23-10: 14US/7India = 21
• 1-13-11: 15US/7India = 22
• 1-18-11: 17US/7India = 24
• 5-24-11: 17US/9India/2RepGA = 28
• 8-4-11: 17US/2RepGA/9India/8RussianFed/5Ukraine = 41

F. PHASE IIB BAVI+DOCE VS. REFRACTORY NSCLC (RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, N=120, 'REGISTRATIONAL')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 11 India + 2 RepGA = 37 Sites as of 5-24-11)
...Also listed in: India's CTRI registry ctri.in#2191 (12 sites a/o 3-20-11)
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."
Site Growth:
• 10-11-10: 13 U.S.
• 11-8-10: 18 U.S.
• 11-23-10: 19 U.S.
• 12-6-10: 20 U.S.
• 12-20-10: 21 U.S.
• 2-8-11: 22US/9India = 31
• 3-14-11: 23US/9India = 32
• 5-24-11: 24US/11India/2RepGA = 37