Avid Bioservices Inc (CDMO)

[cjgaddy]

ClinicalTrials.gov for Bavi+CP vs. 1st-Line NSCLC randomized Ph.2B trial updated 9-27-10 – went from 2 to 5 U.S. sites…

“Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer”
• NCT01160601 - This study is currently recruiting participants.
http://clinicaltrials.gov/ct2/show/NCT01160601

LOCATIONS:
American Institute of Research, Whittier, California - Recruiting
Principal Investigator: Merrill Shum, MD

Southeast Nebraska Cancer Center, Lincoln, Nebraska - Recruiting
Principal Investigator: Alan Berg, MD

San Juan Oncology Associates, Farmington, New Mexico - Recruiting
Principal Investigator: Jeffrey Neidhart, MD

Gabrail Cancer Center, Canton, Ohio - Recruiting
Principal Investigator: Nashat Gabrail, MD

Signal Point Clinical Research Center, Middletown, Ohio - Recruiting
Principal Investigator: Nandagopal Vrindavanam, MD

Health Authority: USA: FDA; India: Drugs Controller General of India

= = = = = = = = = = = =
G. Phase IIb Bavi+CP vs. 1st-Line NSCLC (randomized, unblinded, 'confirmatory')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (5 U.S. Sites as of 9-27-10)
…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.