- Array Files IND Application for a Phase 1 Clinical Trial in Cancer Patients -

Array BioPharma Inc. (NASDAQ: ARRY) 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.