Avid Bioservices Inc (CDMO)

[cjgaddy]

Two more U.S. sites added to the Frontline NSCLC trial. 45 total sites now for the 2 Ph2b randomized NSCLC trials. Note that the Frontline NSCLC trial, with its 24 sites, has now exceeded its stated goal of “~20 sites”.

G. PHASE IIB BAVI+CP VS. FRONT-LINE NSCLC (RANDOMIZED, UNBLINDED, 'CONFIRMATORY')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601
17 U.S. & 7 India Sites as of 1-18-11 (was 15 U.S., 7 India sites as of 1-13-11)
…Per J.Shan (VP/Clin+RegAffairs), 7-14-10 CC: "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

F. PHASE IIB BAVI+DOCE VS. REFRACTORY NSCLC (RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, N=120, ‘REGISTRATIONAL’)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163
21 U.S. Sites as of 12-20-10 (was 20 U.S. sites as of 12-6-10)
…Per CEO S.King, 3-17-10/Roth: "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.