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Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2013
Date:5/6/2013

vs. 4.5 months), an improved median event free survival (5.3 months vs. 2.4 months) and a greater overall response rate (24% vs. 0%) compared to patients with elevated AAG. These results may enable more precise targeting of patient populations who will benefit from ARRY-520.

ARRY-520 is currently advancing in three clinical trials.  Continued positive results in these trials will define a clear path to late stage development:

  • Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade and dexamethasone therapy. 
  • Dose escalation trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM.
  • Investigator-sponsored dose escalation trial in combination with Kyprolis® in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy.
  • ARRY-614 – Advances in clinical trials in myelodysplastic syndromes ARRY-614 is a dual p38/Tie2 kinase inhibitor offering a unique mechanism of action for the treatment of myelodysplastic syndromes (MDS). In an initial Phase 1 dose-escalation trial in patients with low or intermediate-1 risk MDS, ARRY-614 achieved a response rate of 38% hematologic improvement at the highest dose evaluated. During the quarter, Array continued to evaluate an optimized formulation of ARRY-614 in a clinical trial with a similar patient population. This Phase 1 dose-escalation trial, currently in an expansion phase after reaching the maximum tolerated dose, has the goal of identifying the recommended dose for future clinical trials. As presented at ASH 2012, this new formulation has demonstrated improved bioavailability and target coverage, including higher peak plasma concentrations and overall exposures, as compared to the original formulation.

    At the end of 2012, the FDA provided guidance on future development for this program, including a disc
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