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Array Initiates Phase I Cancer Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Array BioPharma, Inc. has initiated dosing in a Phase I trial with ARRY-520, a targeted small molecule anticancer drug. ARRY-520 is a potent Kinesin Spindle Protein (KSP) inhibitor that caused marked tumor regression in preclinical models of human cancer at tolerated doses, often leading to complete, durable responses.

The Phase I open-label, dose-escalation trial is designed to evaluate the safety, tolerability and pharmacokinetics of ARRY-520 following intravenous administration to patients with advanced cancer. The trial will also examine indicators of therapeutic activity in these patients.

ARRY-520 inhibits KSP, a protein that plays an essential role in mitotic spindle formation with subnanomolar potency in both enzymatic and cellular assays. Unlike current cancer therapies — taxanes and vinca alkaloids — KSP inhibitors do not demonstrate side effects such as peripheral neuropathy because the KSP protein is not expressed in non-proliferating nerve cells.

In studies comparing the most clinically advanced competitor compound and standard of care agents like taxanes and vinca alkaloids, ARRY-520 has shown superior efficacy in multiple preclinical models.

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