Array BioPharma Inc. received notification from the US Food & Drug Administration that its investigational new drug (IND) application is now in effect for ARRY-142886 (AZD6244), allowing Array to proceed with human clinical studies in cancer patients. ARRY-142886 (AZD6244), the company's first small molecule anticancer compound, interferes with MEK, one step in a critical cellular hyperproliferation pathway in human cancer cells. Oral administration of ARRY-142886 (AZD6244) in certain preclinical skin, pancreatic, colon, lung and breast tumour models resulted in tumour suppression and regression.
"The clearance to advance ARRY-142886 (AZD6244) into human clinical trials is a significant achievement for Array and further demonstrates our ability to create high quality clinical candidates," said Kevin Koch, president and chief scientific officer. "We continue to build a strong pipeline of orally active drug candidates focused on cancer and inflammatory disease, and we plan to advance select programmes to Phase II clinical proof of concept."
In December 2003, AstraZeneca PLC acquired exclusive, worldwide rights to ARRY-142886 (AZD6244) and related intellectual property for oncology indications. Array is responsible for the IND filing and performing a Phase I clinical trial. AstraZeneca will be responsible for all other aspects of clinical development and commercialization.
Array plans to commence the Phase I trial this spring at two academic medical centres in the United States. The trial is designed to evaluate tolerability and pharmacokinetics of ARRY-142886 (AZD6244) following oral administration to patients with advanced cancer. In addition, the trial is designed to examine patients for indications of biological activity as well as pharmacodynamic and tumour biomarkers.