Development and clinical microdose study of an albumin-binding PET imaging agent for blood flow meas
|Funding from Vinnova||SEK 5 000 000|
|Project duration||November 2010 - November 2014|
Purpose and goal
The goal of the project was to develop and produce a novel radiotracer for imaging of blood flow/permeability in tumors and to investigate its suitability in first clinical trials. Progress has been made in preclinical development both in the CMC and the bio-analysis part of the project. Peptide synthesis yielded functional and stable ABY-028 peptide. In vivo studies with [68Ga]ABY-028 proved the suitability for blood flow imaging. Toxicology studies, GMP production and planning for clinical trial phase 1 are being initiated. Clinical trials with ABY-028 will be initiated in Q2 2015.
Expected results and effects
Functional and stable ABY-028 was produced by peptide synthesis. In vivo studies in rodents with [68Ga]ABY-028 proved the suitability for blood flow imaging. Toxicology studies and GMP production are being initiated. The clinical trials with ABY-028 will be initiated in Q2 2014. A successful first clinical trial will allow further product development of ABY-028 as novel radiotracer for imaging of blood flow/permeability in tumors.
Planned approach and implementation
The collaboration between an academic group and a small biopharmaceutical company (SME) exemplifies a way allowing the transition of basic scientific findings from bench to bedside. Partial external funding allowed proceeding to the most expensive activities during early product development, toxicology studies, GMP production and clinical trial of the candidate drug. The proof of concept to be obtained in the first human study is crucial for further product development. The current project has made progress towards clinical trials with ABY-028 which will be initiated in Q2 2015.