Thursday, November 15, 2007

An Array of Development and Discovery

Array Biopharma (NASDAQ: ARRY) is really hitting on all cylinders with eight-wholly owned development programs and a rich portfolio of discovery programs. Let’s take a closer look under the hood…shall we?

ARRY 162
– neared completion of a Phase I trial with of adding to methotrexate in patients with stable rheumatoid arthritis. Plans are to begin a Phase II trial in rheumatoid arthritis patients in early 2008. It is likely to be the first MEK inhibitor to enter Phase II studies for the treatment of inflammatory disease

ARRY 380
– an oral, selective ErbB-2 inhibitor for cancer, in a Phase 1 clinical trial.

ARRY 520
– a small molecule Kinesin Spindle Protein inhibitor, in a Phase I dose escalation clinical trial in cancer patients. Has caused marked tumor regression in preclinical models of human solid tumors and human leukemias.

ARRY 543
– an ErbB-2 and EGFR dual inhibitor; produced stable disease in refractory patients with advanced solid tumors in Phase I trial, was well-tolerated, systemic concentrations of increased with escalating doses at all dose levels tested. Plans are to initiate Phase Ib / II, which include: expansion of the Phase I trial in 30 to 40 additional patients at the maximum tolerated dose, half of the patients will have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients will have other ErbB-family-driven cancers; A Phase Ib/II trial in combination with cetuximab in patients with metastatic colorectal cancer; A Phase Ib/II trial in combination with capecitabine in patients with metastatic breast cancer; and a Phase Ib/II trial in combination with trastuzumab as maintenance therapy for patients with metastatic breast cancer

ARRY 614 – a p38 / Tie2 inhibitor has completed regulated safety assessment testing and now is preparing an IND application with filing plans for1Q08.

ARRY 704 – a novel MEK inhibitor being developed by AstraZeneca, into a Phase 1 clinical trial in cancer patients.

ARRY 797
– a novel p38 inhibitor, in a Phase I multiple ascending dose clinical trial in healthy volunteers, which is nearing completion. Plans are to initiate a Phase II trial with to treat patients with post-operative dental pain.

ARRY 886
– a novel MEK inhibitor, in Phase II clinical development for the treatment of metastatic melanoma, colorectal, pancreatic and non-small cell lung cancers. These trials are being conducted by Array’s partner AstraZeneca.

Array recently announced a worldwide strategic collaboration with Celgene focused on the discovery, development and commercialization of novel therapeutics in cancer and inflammation, an option was granted to Celgene to license worldwide rights to drugs developed under the collaboration that are directed to two of the four mutually selected discovery targets. Array will be responsible for all discovery and clinical development through Phase I or Phase IIa. For the programs selected by Celgene, Celgene will be responsible for later-stage clinical development and commercialization, except for Array's co-promotion rights in the U.S. Under the agreement, Celgene made an upfront payment of $40M and Array is entitled to receive, for each drug licensed to Celgene, potential milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are achieved and $300 million if certain commercial milestones are achieved, as well as royalties on net sales. Array will retain all rights to the other programs

Wow…that was a mouthful and not necessarily new news however, it is nice to pull a comprehensive (and relatively) concise snapshot update together. Things are looking very promising over at Array…let’s hope everything remains on track!

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