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Array BioPharma Provides Updates On Clinical Data At The 2012 American Society Of Hematology Meeting


Array BioPharma (NASDAQ: ARRY) today announced positive data for ARRY-520 and ARRY‑614 at the 2012 Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.

New results presented at the meeting for ARRY-520 in addition to those described in the abstracts published by ASH in early November included:

Overall survival of 19 months and progression free survival of 3.7 months were observed in multiple myeloma patients taking ARRY-520 alone A clinical benefit rate (≥MR) of 50% was observed in heavily pre-treated (median 10 prior regimens) multiple myeloma patients taking ARRY-520 plus dexamethasone who were selected for low AAG levels Initial signs of clinical activity were observed in the ongoing ARRY-520+Kyprolis® (carfilzomib) combination trial: 56% clinical benefit rate (≥MR) In a Phase 2 trial with ARRY-520 in patients with triple-refractory multiple myeloma and a median number of 10 prior treatment regimens, ARRY-520 plus low-dose dexamethasone demonstrated a 22% overall response rate (≥ partial response, or PR), with manageable safety. The most common drug-related adverse events include myelosuppression, fatigue and mucosal inflammation. This response rate is comparable to the response rates reported in pomalidomide and Kyprolis studies, which included patients with only half the number of median prior treatment regimens.

As presented at ASH, researchers found that AAG (acute phase protein alpha-1-acidic glycoprotein) may be a biomarker enabling better patient selection for response to ARRY-520. A related abstract assessing the same group of ARRY-520-treated patients observed that, for patients retrospectively selected with a lower AAG level, the overall response rate (≥PR) increased to 33% (from 22%) with a median time on study of 6.2 months. The clinical benefit rate (≥MR) was 50% in the selected population.

"Multiple myeloma remains an incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to IMiDs and proteasome inhibitors," said Jatin J. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. "ARRY-520 is a first-in class drug in myeloma with a novel mechanism of action that is very well tolerated and importantly shows very encouraging clinical activity in heavily pre-treated patients who have limited therapeutic options. Furthermore, I am excited about the potential identification of a selection marker, which would help us identify which patients have the best chance to benefit from receiving ARRY-520."

Interim data from an ongoing combination trial of ARRY-520 with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® (bortezomib) were also reported at the conference. The combination has demonstrated early signals of activity, with a 56% clinical benefit rate (≥MR). In addition, it has been well tolerated with limited hematologic toxicity and a manageable side effect profile.

ARRY‑520 is currently advancing in three clinical trials, including the two trials presented at ASH. Continued positive results in any one of 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. Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM. Phase 1b investigator-sponsored trial in combination with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy. In the Phase 1 trial with ARRY-614, a dual p38/Tie2 inhibitor, the new formulation demonstrated improved bioavailability and inter-patient variability in our ongoing study of low or intermediate-1 risk Myelodysplastic Syndromes (MDS). With this new formulation, peak plasma concentrations and overall exposures are higher than with the original formulation, possibly affording more extensive Tie2 inhibition. The ongoing Phase 1 dose escalation trial of the optimized ARRY-614 formulation may further our understanding of the contributions of these targets to the pathogenesis of MDS. In our prior study in a similar population, we observed a 38% response rate for hematologic improvement in patients receiving the highest dose of the prior formulation. At this dose, ARRY-614 demonstrated multilineage hematologic improvement in 67% of the responders, improving two or more cytopenias (neutropenia, thrombocytopenia and/or anemia). The most common drug related adverse events in this study included diarrhea and skin rash.

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