Avid Bioservices Inc (CDMO)

[freethemice]

You people are all doing exactly what AF wants you to do. Relax, breathe deeply. I believe that pharmacokinetic
data is usually collected as part of a PHASE I trial. It has to be known before anything else is done.
It involves studying how the drug behaves in test subjects. They want to know what is the half-life, etc.
I am not at all surprised that this was only done with 18 subjects. There shouldn't be any need to
do it again. Maybe they did do it again for 18 patients, but the point is this is not something that needs
to be done in every patient and isn't.
http://en.wikipedia.org/wiki/Pharmacokinetic

This is the paper published about the phase I trial.
http://www.ncbi.nlm.nih.gov/pubmed/21989064

Phase I safety and pharmacokinetic study of bavituximab, a chimeric phosphatidylserine-targeting monoclonal antibody, in patients with advanced solid tumors.
Gerber DE, Stopeck AT, Wong L, Rosen LS, Thorpe PE, Shan JS, Ibrahim NK.
Source
Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Abstract
PURPOSE:
Bavituximab is a chimeric immunoglobulin G1 phosphatidylserine-targeting monoclonal antibody that triggers vascular disruption and enhances antitumor immune response. This phase I study assessed the safety and pharmacokinetics of bavituximab in patients with advanced solid tumors.

EXPERIMENTAL DESIGN:
Patients with refractory advanced solid tumors were enrolled into four sequential dose-escalation cohorts (0.1, 0.3, 1, or 3 mg/kg bavituximab weekly) with two dosing schedules. Patients in the 0.1 and 0.3 mg/kg cohorts received bavituximab on days 0, 28, 35, and 42. Patients in the 1 and 3 mg/kg cohorts were administered bavituximab on days 0, 7, 14, and 21. Safety, pharmacokinetics, and tumor response were assessed.

RESULTS:
Twenty-six patients were accrued. No maximum tolerated dose was reached. Six serious adverse events occurred in five patients, including one pulmonary embolism at 3 mg/kg, which was the only dose-limiting toxicity (DLT) in the study. Bavituximab half-life ranged from 37 to 47 hours, with no accumulation seen following administration of multiple doses. Activated partial thromboplastin time was modestly prolonged in vitro at the highest dose tested. As assessed on day 56, a total of 18 patients were evaluable for efficacy, of whom 10 had disease progression and none had an objective response.

CONCLUSIONS:
Bavituximab was well tolerated at doses ranging up to 3 mg/kg weekly. Pharmacokinetic studies support a weekly dosing regimen. Additional phase I and II clinical trials are in progress to investigate bavituximab in combination with chemotherapy and other molecularly targeted agents.