ARRY-380 is a selective, orally-active inhibitor of ErbB-2, a receptor kinase target that has been found to be over-expressed in breast and a number of other cancers, and has shown efficacy and a low side effect profile in preclinical models of human cancer. We believe the advantages of ARRY-380 include patient preference for an orally-active drug as well as improved efficacy versus or in combination with standard of care in preclinical models of human breast cancer.
About ErbB-2 Inhibition
The growth factor receptor tyrosine kinases HER-2 (ErbB-2) and EGFR (ErbB-1) play a major role in controlling cell growth and differentiation. These two receptor tyrosine kinases are often over-expressed and / or abnormally active in a wide variety of tumor types. Specifically, ErbB-2 is over expressed in breast, ovarian and stomach cancers. Currently Herceptin® is an intravenously-dosed protein therapeutic on the market for the treatment of breast cancers that over-express ErbB-2. Herceptin has also recently been reported to show promising therapeutic benefits in early, post-surgery, breast cancer patients being treated chronically. We believe these results suggest a high potential value for an orally active drug which regulates ErbB-2 and that can be conveniently dosed for extended periods of time.
Phase 1 Clinical Trial
During fiscal 2008, we initiated a Phase 1 trial of ARRY-380 in advanced cancer patients. The trial is a multiple dose, open-label study that is designed to evaluate tolerability, pharmacokinetics and safety following oral administration to patients.
Future Milestones
During fiscal 2009, we plan to complete the Phase 1 trial and initiate Phase 1b combination trials.
Scientific Posters
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