Avid Bioservices Inc (CDMO)

[hutschi]

First-in-Man Evaluation of 124I-PGN650: A PET Tracer for Detecting phosphatidylserine as a Biomarker of the Solid Tumor Microenvironment

With Bavituximab. ... and PS....


If already posted pls delete.

Abstract
Purpose: PGN650 is a F(ab0
)2 antibody fragment that targets phosphatidylserine (PS), a marker normally absent that becomes
exposed on tumor cells and tumor vasculature in response to oxidative stress and increases in response to therapy. PGN650 was
labeled with 124I to create a positron emission tomography (PET) agent as an in vivo biomarker for tumor microenvironment and
response to therapy. In this phase 0 study, we evaluated the pharmacokinetics, safety, radiation dosimetry, and tumor targeting of
this tracer in a cohort of patients with cancer.
Methods: Eleven patients with known solid tumors received approximately 140 MBq (3.8 mCi) 124I-PGN650 intravenously and
underwent positron emission tomography–computed tomography (PET/CT) approximately 1 hour, 3 hours, and either 24 hours
or 48 hours later to establish tracer kinetics for the purpose of calculating radiation dosimetry (from integration of the organ
time-activity curves and OLINDA/EXM using the adult male and female models).
Results: Known tumor foci demonstrated mildly increased uptake, with the highest activity at the latest imaging time. There were
no unexpected adverse events. The liver was the organ receiving the highest radiation dose (0.77 mGy/MBq); the effective dose
was 0.41 mSv/MBq.
Conclusion: Although 124I-PGN650 is safe for human PET imaging, the tumor targeting with this agent in patients was less than
previously observed in animal studies.




https://www.google.at/url?sa=t&source=web&rct=j&url=http://journals.sagepub.com/doi/pdf/10.1177/1536012117733349&ved=0ahUKEwj22sbh8YnXAhWMvRoKHa3wAOY4FBAWCC0wBQ&usg=AOvVaw3DMkfx1Vw0MGApRT3iEPYl