Boulder, CO (Press Release) - Array BioPharma Inc. (NASDAQ: ARRY) today announced that five abstracts were accepted for presentation, in­­clud­ing two oral presentations, at the 2013 Annual Meeting of the Ameri­can Society of Hematology (ASH) on its two wholly-owned hematology drug can­di­dates, ARRY-520, a KSP inhibitor, and ARRY-614, a dual p38/Tie2 inhibitor.

Ron Squarer, Chief Executive Officer of Array, noted, "We look forward to the oppor­tu­ni­ty to present updates on ARRY-520 and ARRY-614 at the ASH meeting.  We believe that results from multiple clin­i­cal and pre­clin­i­cal studies of ARRY-520 will both dem­onstrate its utility as an active drug with a novel mech­a­nism for multi­ple myeloma patients, and sup­port the broad devel­op­ment plan we recently announced to move this important agent to­ward regu­la­tory approval."

The abstracts can be accessed through the American Society of Hematology website, www.hematology.org/Meetings/Annual-Meeting.  After the presentations, the posters and presentation slides will be avail­able as PDFs on Array's website at www.arraybiopharma.com.

ASH is the world's largest professional society concerned with the causes and treat­ments of blood dis­orders, and presentation of clin­i­cal trial results at the annual conference marks an important strategic mile­stone in the con­tinued devel­op­ment of these two drugs.

ARRY-520 – KSP inhibitor for Multiple Myeloma (MM):

Four abstracts on ARRY-520 were accepted for presentation, in­­clud­ing one oral presentation.  The abstracts in­clude data from the fol­low­ing studies:  ARRY-520 as single agent and with dexa­meth­a­sone, ARRY-520 plus Kyprolis® (car­filz­o­mib), ARRY-520 plus Velcade® (bor­tez­o­mib) and pre­clin­i­cal data regarding ARRY-520 plus Pomalyst® (poma­lido­mide).

ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS):

An oral presentation will also be given on data from a Phase 1 clin­i­cal trial in patients with MDS using an optimized formulation of ARRY-614 with im­proved bioavailability:

 
About ARRY-520 for MM

ARRY-520 is a highly selective, targeted KSP inhibitor with a mech­a­nism of action distinct from cur­rently avail­able drugs to treat MM.  Even with recent ad­vances with IMiDs and pro­te­a­some inhibitors, the vast majority of patients progress on these ther­a­pies, leaving an unmet need for novel agents which provide benefit in com­bi­na­tion with, and after these ther­a­pies have failed.  ARRY-520 has dem­onstrated clin­i­cal activity as a mono­therapy as well as in com­bi­na­tion with Kyprolis in heavily pre-treated patients.  In addi­tion, ARRY-520 in com­bi­na­tion with Velcade has dem­onstrated pre­clin­i­cal activity and initial signs of clin­i­cal activity, in­­clud­ing responses and prolonged stable disease.

Across multiple studies, ARRY-520 has been well tolerated with no periph­eral neu­rop­athy and limited non-hematologic toxicity.  Adverse events are generally limited to transient, non-cumulative and predominantly asymptomatic hema­to­logic effects.

Based on the strength of data from ongoing or com­pleted clin­i­cal trials, and recent positive discussions with the Food and Drug Admin­istra­tion (FDA), Array ex­pec­ts to ini­ti­ate a global Phase 3 study of ARRY-520 in patients with RRMM, of which there are more than 70,000 patients in developed countries.   The trial will eval­u­ate ARRY-520 in several hundred patients with RRMM, com­par­ing Kyprolis plus ARRY-520 to Kyprolis alone, with Progression Free Survival as the pri­mary end­point.  Key sec­ond­ary end­points in­clude Overall Survival and safety and efficacy dif­fer­ences between patients with low- and high-levels of AAG, a poten­tial patient selection marker.  The trial design may in­clude an interim analysis of Objective Response Rate, which if positive, could sup­port an accelerated regu­la­tory filing.

About ARRY-614 for MDS

ARRY-614 is being studied in Low/Intermediate-1 risk MDS, a pop­u­la­tion of more than 100,000 patients in developed countries.  In a pre­vi­ous study of ARRY-614, multi-lineage activity was observed with the most promising effects seen in patients with thrombo­cytopenia and neu­tro­penia, with several platelet transfusion-dependent patients becoming transfusion-independent.  Array is eval­u­ating a new formulation of ARRY-614 in an ongoing dose-escalation clin­i­cal trial. The maximum tolerated dose has been estab­lish­ed and expansion cohorts have been fully enrolled and are ongoing.  Pharmacokinetic and pharmacodynamics assays per­formed as part of the trial have dem­onstrated im­proved bioavailability and target coverage relative to the pre­vi­ously-evaluated formulation. In addi­tion, the study is eval­u­ating safety and the pre­lim­i­nary efficacy of ARRY-614 based on Hematologic Improvement (increases in red blood cells, neu­tro­phils and/or plate­lets), the reduction or independence from red blood cell and/or platelet transfusions, the durability of these responses, and Overall Survival.  Mature response data from this trial is ex­pec­ted early next year.  With these results, Array plans to discuss devel­op­ment plans with regu­la­tory author­i­ties.

About Array BioPharma

Array BioPharma Inc. is a bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of targeted small molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage on­col­ogy devel­op­ment com­pany, with two wholly-owned hematology pro­grams and two partnered MEK inhibitors in multiple pivotal trials.  ARRY-520 is a targeted KSP inhibitor being developed to treat patients with multiple myeloma and has dem­onstrated clin­i­cal activity as a mono­therapy, and in com­bi­na­tion with both Kyprolis® (car­filz­o­mib) and Velcade® (bor­tez­o­mib).  ARRY‐614 is an oral p38/Tie2 inhibitor with a novel mech­a­nism of action being developed to treat patients with myelo­dys­plastic syn­dromes.  Both selumetinib, partnered with AstraZeneca, and MEK162, partnered with Novartis, are being studied in several pivotal trials in a variety of solid tumors.  For more in­­for­ma­tion on Array, please go to www.arraybiopharma.com.

Forward-Looking Statement

This press release con­tains forward-looking state­ments within the meaning of the Private Securities Litigation Reform Act of 1995, in­­clud­ing state­ments about the timing of the announcement of the results of clin­i­cal trials for our pro­pri­e­tary and our partnered pro­grams, the timing of the completion or initiation of further devel­op­ment of our wholly-owned pro­grams, ex­pec­ta­tions that events will occur that will result in greater value for Array, the poten­tial for the results of ongoing pre­clin­i­cal and clin­i­cal trials to sup­port regu­la­tory approval or the market­ing success of a drug can­di­date, our ability to partner our pro­pri­e­tary drug can­di­dates for up-front fees, mile­stone and/or royalty payments, our future plans to progress and develop our pro­pri­e­tary pro­grams, and our plans to build a late-stage devel­op­ment com­pany. These state­ments involve sig­nif­i­cant risks and un­cer­tain­ties, in­­clud­ing those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Com­mis­sion. Because these state­ments reflect our current ex­pec­ta­tions concerning future events, our actual results could differ materially from those antic­i­pated in these forward-looking state­ments as a result of many factors. These factors in­clude, but are not limited to, our ability to con­tinue to fund and suc­cess­fully progress internal research and devel­op­ment efforts and to create effective, commercially viable drugs; risks asso­ci­ated with our dependence on our col­lab­o­rators for the clin­i­cal devel­op­ment and com­mer­cial­iza­tion of our out-licensed drug can­di­dates; the ability of our col­lab­o­rators and of Array to meet objectives tied to mile­stones and royalties; our ability to effectively and timely conduct clin­i­cal trials in light of in­creas­ing costs and dif­fi­culties in locating appro­pri­ate trial sites and in enrolling patients who meet the criteria for certain clin­i­cal trials; risks asso­ci­ated with our dependence on third-party service providers to suc­cess­fully conduct clin­i­cal trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; the extent to which the pharma­ceu­tical and bio­technology industries are willing to in-license drug can­di­dates for their prod­uct pipe­lines and to col­lab­o­rate with and fund third parties on their drug discovery activities; our ability to out-license our pro­pri­e­tary can­di­dates on favorable terms; and our ability to attract and retain ex­peri­enced scientists and man­agement. We are providing this in­­for­ma­tion as of November 7, 2013. We under­take no duty to update any forward-looking state­ments to reflect the occurrence of events or cir­cum­stances after the date of such state­ments or of antic­i­pated or unanticipated events that alter any assump­tions under­lying such state­ments.

Source: Array BioPharma.