Avid Bioservices Inc (CDMO)

[cjgaddy]

Ebuy, a 2-11-14 (yesterday) MLV PPHM update by Graig Suvannavejh (PhD, Senior Analyst) says, “Near-term catalysts. We next look for: 1) Interim data from a P1/2 trial of Bavi + Nexavar in Liver Cancer (next month)…”

= = = = = = = = = = = = = =
H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
...Note: Sorafenib = Onyx/Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/mwdc2ql (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb'12-Mar'13 ~8 times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia: http://tinyurl.com/la5t9cq
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."

= = = = = = = = = = = = =
12-10-13 Q2 PR http://tinyurl.com/mw776mkT
• “A Phase I/II IST evaluating bavituximab in combination with sorafenib [Nexavar] in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). Interim data has been accepted for oral presentation at an upcoming scientific conference in the first quarter of 2014.”