Array Starts Phase I for p38 Drug

Array BioPharma has filed an Investigational New Drug (IND) application for ARRY-614 with the FDA and has initiated a Phase 1 clinical trial. ARRY-614, a potent, orally active p38 / Tie2 inhibitor, has shown good efficacy and a low side effect profile in preclinical models of human cancer and arthritis, according to Array. The compound will initially be evaluated in a single and multiple dose escalation study in normal, healthy volunteers for safety, tolerability, exposure and inhibition of mechanism-related biomarkers.

“We believe the dual inhibition of p38 and Tie2 may produce additive and/or synergistic effects with other therapies in treating multiple myeloma and other cancers as well as certain inflammatory diseases,” said John Yates, M.D., Array’s chief medical officer. “We look forward to seeing ARRY-614’s clinical progress so we can test this hypothesis.”

P38 is a kinase target that regulates the production of PGE2 as well as numerous pro-inflammatory cytokines, in particular, TNF, IL-6 and IL-1. These cytokines can also act as cellular growth factors and are often up-regulated in certain cancers including prostate, ovarian and multiple myeloma. Additionally, p38 may play a role in certain resistance mechanisms or metastatic progression in cancer. Tie2, a receptor tyrosine kinase, plays an important role in angiogenesis and blood vessel growth which may lead to uncontrolled cell growth that characterizes a number of cancer and chronic inflammatory diseases.