Avid Bioservices Inc (CDMO)

[Thurly]

The earlier Indian trial was run using RECIST.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=48393

The trial was monitored according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
http://www.fiercebiotech.com/press-releases/peregrine-pharmaceuticals-reports-positive-results-phase-ii-bavituximab-lung-cancer-0

The trial that most closely tracks the docetaxel/bavituximab trial protocol that's at the centre of the current controversy was done in Advanced and Metastatic Breast Cancer. That data was very impressive as reported at ASCO:
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=43470
Background: Bavituximab, a novel IgG1 monoclonal antibody which targets membrane phosphatidylserine complexed with ß2-glycoprotein I on tumor vasculature was tested in combination with docetaxel in a multicenter open label phase 2 trial in adults (n=46) with locally advanced or metastatic breast cancer.

Methods: Subjects received intravenous administration of weekly doses of 3 mg/kg bavituximab on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles along with docetaxel 35 mg/m2 in a Simon 2-stage design. Tumor response was determined by use of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Results: 46 caucasian female subjects median age 49 (range 30-72) were treated. Prior treatment included chemotherapy in all 46 pts (100%), surgery in 40 pts (87%), and radiation therapy in 13 pts (28%). Overall response rate (CR+PR) was seen in 28/46 (60.9%, CI 45.4-74.9) with clinical complete response seen in 10.9% and partial response seen in 50%; median progression-free survival (PFS) of 7.4 mos (95% CI, 6.0-9.0); median duration of response (MDR) of 6.0 mos (95% CI 5.6-7.0).

FWIW - My sense after following the company carefully for the last nearly four years: they went to India and Georgia because they were broke. I don't get the sense they went there to cheat. They did what they could to ensure the trials were well run.