BioMarin Pharmaceutical has started an open-label Phase 1/2 trial evaluating BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of genetically-defined cancers.
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The primary objective of the study is to establish the maximum tolerated dose of daily oral BMN 673.
However, the secondary objectives are to evaluate the safety, tolerability, preliminary efficacy and phatrmacodynamic activity of BMN 673, and to determine the pharmacokinetic profile and recommended Phase 2 dose.
BioMarin Pharma chief medical officer Hank Fuchs said PARP inihibtors have been validated to show survival benefits in cancer patients with tumors that have defects in DNA repair or in combination with DNA damaging agents, and BMN 673 appears to have superior potency, selectivity, and bioavailability as compared to other products in development.
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