ARRY-300 “ MEK inhibitor: Array completed enrollment in a Phase 1 trial with ARRY-300, a targeted small molecule MEK inhibitor. The Phase 1 trial was a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers. ARRY-300 will be a back-up for ARRY-162.
Two clinical program updates for the treatment of chronic inflammatory disease and pain:ARRY-162 - MEK inhibitor for RA: Array completed a 12 week Phase 2, randomized, double-blind, placebo controlled global proof-of-concept trial with ARRY 162 in patients with active RA who were receiving stable doses of methotrexate for ?‰? 6 weeks. Top-line results are expected to be available in September 2009.
ARRY-797 - p38 inhibitor for AS: Array announced top-line results from its Phase 1, seven-day, dose escalation trial up to 1,200 mg daily of ARRY-797 in healthy volunteers. In addition, the top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day Phase 1b trial in stable RA patients taking methotrexate. A preliminary analysis of both trials indicates that ARRY-797 was well-tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients ™ assessment of pain (VAS score) over the course of the study.
Array continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies and anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array has discontinued the enrollment of new patients in its clinical trial of ARRY-797 in ankylosing spondylitis. Array is evaluating alternative development paths in sub-chronic pain and supportive care indications.
Array ™s Information Technology Platform recognized by CIO magazine: IDG's CIO magazine announced Array as a recipient of the 2009 CIO 100. The 22nd annual award program recognizes organizations around the world that exemplify the highest level of operational and strategic excellence in information technology.
Array received additional capital: Array received $40.0 million in additional capital from the Deerfield Funds on August 5, 2009 under a loan facility agreement dated May 15, 2009. The outstanding principal under the new loan is due by April 2014 and interest is payable monthly. Principal and interest can be repaid, at Array ™s option, at any time with shares of Array common stock.
Array will hold a conference call on Tuesday, August 11, 2009, at 9:00 a.m. eastern time to discuss these results. Robert E. Conway, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.
www.arraybiopharma