Array BioPharma Inc. has filed an Investigational New Drug (IND) application for ARRY-520 with the US Food and Drug Administration and is now able to proceed with human clinical studies.
ARRY-520 is a potent Kinesin Spindle Protein (KSP) inhibitor that caused marked tumour regression in preclinical models of human solid tumours and human leukaemia's, often leading to durable responses.
Array plans to commence the phase 1 clinical trial at three academic medical centres in the United States. The open-label, dose-escalation trial is designed to evaluate the safety and tolerability and pharmacokinetics of ARRY-520 following intravenous administration to patients with advanced cancer. In addition, the trial is designed to examine indicators of therapeutic activity in these patients.
"Advancing ARRY-520, our small molecule KSP inhibitor, into clinical trials is a significant achievement for Array and marks our fourth drug to enter clinical development during 2006 and fifth drug overall," said Kevin Koch, PhD, president and chief scientific officer. "We've now achieved our goal of having five drugs in clinical development by the end of 2006."
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation of targeted small molecule drugs to treat life threatening and debilitating diseases. Our proprietary drug development pipeline is focused on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important protein targets.