Development and clinical microdose study of an albumin-binding PET imaging agent for blood flow measurement

Diarienummer 2010-00521
Koordinator Affibody AB
Bidrag från Vinnova 5 000 000 kronor
Projektets löptid november 2010 - november 2014
Status Genomfört

Syfte och mål

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. Peptide synthesis yielded functional and stable ABY-028. In vivo studies with [68Ga]ABY-028 proved the suitability for blood flow imaging. Toxicology studies, GMP production were performed. Clinical trials with ABY-028 will be initiated in Q2 2015. A successful first clinical trial will allow further product development of ABY-028 as novel radiotracer for imaging of blood flow/permeability in tumors.

Resultat och förväntade effekter

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 finalyzed. The clinical trials with ABY-028 will be initiated in Q2 2015. A successful first clinical trial will allow further product development of ABY-028 as novel radiotracer for imaging of blood flow/permeability in tumors.

Upplägg och genomförande

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.

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