ARRAY HAS IND APPLICATION FOR CANCER DRUG STUDIES
Array BioPharma has an investigational new drug (IND) application now in effect with the FDA for ARRY-334543, allowing Array to proceed with human clinical studies in cancer patients.
ARRY-334543, a second small molecule anticancer compound, is a dual growth factor inhibitor, which disrupts both ErbB-2 and EGFR, two critical targets regulating cellular hyperproliferation pathways in human cancers. Oral administration of ARRY-334543 in preclinical models of human breast, lung, or epidermal carcinoma tumors resulted in significant anti-tumor activity.
Array plans to commence the Phase I clinical trial this fall at two academic medical centers in the U.S. and Canada. The open-label trial is designed to evaluate tolerability and pharmacokinetics of ARRY-334543 following oral administration to patients with advanced cancer. In addition, the trial is designed to examine indicators of therapeutic activity in these patients.