Array Biopharma (NASDAQ: ARRY) is an incredibly well positioned tour de force biopharmaceutical company with a strong balance sheet, a vast portfolio of six wholly owned compounds, and a variety of pharma partnered development efforts with AstraZeneca (NYSE: AZN), Celgene (NASDAQ: CELG), InterMune (NASDAQ: ITMN) and Roche (Swiss: RO.SW). President and CEO Robert Conway and team have done a masterful job navigating the turbulent financing waters with a quarterly burn of approximately $20M per quarter with a current cash position of approximately $140M.
The conference call this morning kicked off bright and early at 7:00am. The next value inflection point shall come via the completion of a Phase II study of ARRY-797, a pan-cytokine inhibitor, in acute inflammatory pain, at some point in February. Here is a provided summary of recent accomplishments within the ARRY wholly owned assets for the quarter.
Proprietary Research Programs
- Completed enrollment of a Phase II trial with ARRY-797, a novel inhibitor of TNF, IL-1 and IL-6 as well as PGE2, to treat patients with post-operative dental pain.
- Completed a Phase Ib multiple ascending dose trial with the MEK inhibitor, ARRY-162, added to methotrexate in patients with stable rheumatoid arthritis.
- Initiated a Phase II trial with ARRY-162 added to methotrexate in 200 patients with active rheumatoid arthritis.
- Presented Phase I data on ARRY-543, an ErbB-2 and EGFR inhibitor, at the 2007 International Conference on Molecular Targets and Cancer Therapeutics and at the San Antonio Breast Cancer Symposium. ARRY-543 produced stable disease in refractory patients with advanced solid tumors and was well-tolerated.
- Began enrolling patients in a Phase I expansion trial at the maximum tolerated dose for ARRY-543; 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.
- Completed patient enrollment in a Phase I dose escalation trial of ARRY-520, a small molecule kinesin spindle protein inhibitor, and started the expansion phase to further evaluate safety, tolerability and preliminary efficacy at the max tolerated dose.
- Completed the first site initiation for a Phase I clinical trial of ARRY-380, an oral, selective ErbB-2 inhibitor for cancer, and anticipate dosing patients this quarter.
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