Recently, Array BioPharma Inc. (ARRY) announced positive interim results on its inhibitor, ARRY-380, from an early-stage, open-label, multiple dose trial in patients with advanced cancer. The company presented the results at the 2009 San Antonio Breast Cancer Symposium. The study is designed to evaluate the safety, tolerability and pharmacokinetics of ARRY-380 following daily oral administration to patients suffering from advanced cancer.

The candidate, which has been effective in preclinical models of human breast cancer resulting in significant anti-tumor activity, is a selective, orally-active ErbB-2 inhibitor being evaluated by Array for cancer indications. ErbB-2 is a receptor kinase target that has been found to be over-expressed in breast cancer as well as other cancers like gastric and ovarian cancers.

The interim results revealed that ARRY-380 showed evidence of tumor regression in eight of the ten heavily pre-treated patients with ErbB2 expressing cancers at doses greater than or equal to 200 mg BID.  Four of the eight patients had prolonged stable disease for 16 weeks or longer. The candidate was well-tolerated in the study. Nausea, rash and fatigue were the predominant adverse events and only minimal diarrhea was observed in patients enrolled in the study. The maximum tolerated dose of the inhibitor in this early stage study has not been established yet, and dose escalation is underway.

As a reminder, Array filed an Investigational New Drug (IND) application for ARRY-380 with the U.S. Food and Drug Administration (FDA) in 2007 and commenced the phase I study in the United States and Canada.

Array BioPharma, founded in 1998 and headquartered in Boulder, Colorado, focuses on developing orally active drugs by utilizing the latest advances in chemistry, biology, and informaticsc. The small molecule drugs which the company aims to develop and commercialize are intended to treat patients with cancer, inflammatory, and metabolic diseases in North America, Europe, and Asia Pacific. Array competes with players like ArQule Inc. (ARQL), Vertex Pharmaceuticals Inc. (VRTX) among others.

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