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ARRY Files IND for ARRY-162 (MEK inhibitor) Cancer Trial

[Announced on Wednesday, July 15, 2009]

http://finance.yahoo.com/news/Array-BioPharma-Advances-Its-bw-3369335717.html?x=0&.v=1

BOULDER, Colo.--(BUSINESS WIRE)--Array BioPharma Inc. (NASDAQ: ARRY - News) today announced the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration to initiate a Phase 1 clinical trial in cancer patients with its most advanced wholly owned MEK inhibitor, ARRY-162. Recent research confirms that the MEK pathway acts as a central axis in the proliferation of different tumors including melanoma, non-small cell lung, head/neck and pancreatic cancers. Array plans to simultaneously develop ARRY-162 for the treatment of both cancer and inflammatory disease. Array is currently completing a worldwide Phase 2, double-blinded clinical trial with ARRY-162 in 200 patients with active rheumatoid arthritis.

“We are excited to expand our proprietary MEK program into oncology for the potential benefit of cancer patients,” said Kevin Koch, Ph.D., President and Chief Scientific Officer. “Increasing evidence confirms that MEK inhibition, either alone or in combination with other agents, is an important therapeutic strategy in treating cancer. We believe ARRY-162 will be most effective in selected populations of cancer patients, such as those with tumors having BRAF or KRAS mutations and in targeted combinations.”

Array believes ARRY-162 is particularly well-suited for use in cancer treatment and has advantages over other MEK inhibitors currently in development, including greater potency, and improved safety and pharmacokinetics. ARRY-162 has been administered to more than 200 patients/volunteers in clinical trials for either safety assessment or the treatment of inflammatory disease. The drug has been well-tolerated and demonstrated significant pharmacodynamic responses in the completed trials. In addition, the Company has completed long-term preclinical regulated safety studies and has identified a commercially viable synthetic process and oral formulation for ARRY-162.

Array is an industry leader in the field of MEK research. Currently, there are four Array-invented MEK inhibitors in clinical development: ARRY-162 and ARRY-300, which are wholly-owned by Array; and AZD6244 (ARRY-886) and AZD8330 (ARRY-704), both of which are being developed by AstraZeneca PLC in the field of oncology under license from Array.

About ARRY-162 Phase 1 Clinical Trial for Cancer

The Phase 1 cancer trial will be an open-label, multiple dose study that is designed to determine the maximum tolerated dose and evaluate safety, pharmacokinetics and pharmacodynamics of ARRY-162 following daily oral administration to advanced cancer patients with solid tumors. The trial is expected to commence in the third quarter of this year.

Array is a Leader in the MEK Research Field

Array was an early entrant in the MEK research field and established leadership quickly. In 2003, Array partnered its first clinical candidate, the MEK inhibitor ARRY-886 (now AZD6244), with AstraZeneca as part of an exclusive collaboration centered on the discovery and development of MEK inhibitors in the field of oncology. As a result of this successful collaboration, AstraZeneca acquired worldwide rights to AZD6244 and two other compounds for use in oncology. Array retained rights to all other MEK inhibitors invented before and during the collaboration. The exclusivity of the parties’ relationship has recently ended, and both companies are now free to independently research, develop and commercialize small molecule MEK inhibitors in the field of oncology. In addition to ARRY-162, Array has a MEK inhibitor, ARRY-300, that has completed a Phase 1 SAD trial in healthy volunteers and will back-up ARRY-162.

About MEK

MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which signals for cancer cell proliferation and survival. MEK is frequently activated in cancer, in particular in tumors that have mutations in the RAS and RAF oncogenes. MEK also regulates the biosynthesis of the inflammatory cytokines TNF, IL-6 and IL-1, which can act as growth and survival factors in cancer. Preclinical data show that MEK inhibitors are additive or synergistic in combination with other agents. In particular, the PI-3K/AKT/mTOR pathway interacts with the RAS/RAF/MEK/ERK pathway in response to growth factor signaling. Simultaneous inhibition of both these pathways has significantly greater preclinical anti-tumor activity compared to inhibition of either pathway alone. Because these pathways are commonly activated in many tumors, we believe that dual MEK and PI3K/AKT/mTOR inhibition could have broad anti-tumor activity.

Recent Developments in the Field

A growing body of clinical data confirms the potential of MEK inhibitors in the treatment of cancer. In a number of studies, MEK inhibitors have demonstrated clinical activity when used as single agents. Most recently, at the 2009 American Association for Cancer Research annual meeting, a 12 percent overall response rate was reported in patients with biliary cancer treated with a MEK inhibitor. At the 2008 American Society of Clinical Oncology annual meeting both partial responses and a complete response in patients suffering from melanomas with RAF mutations treated with a MEK inhibitor were reported. In addition, AstraZeneca recently announced a partnership with Merck to explore the combination of AZD6244 (ARRY-886) with an experimental AKT inhibitor.