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July 19, 2007
KX2-391 Allowed to Proceed to Phase 1 Trials
Kinex Pharmaceuticals was notified today, by the U.S. Food and Drug Administration that its Investigational New Drug, KX2-391, can proceed into Phase 1 Clinical Trials.
“The rapid progress we have made in advancing this novel compound into human trials is extraordinary”, said Dr. Allen Barnett, Chief Executive Officer of Kinex Pharmaceuticals. Barnett, a pharmaceutical industry veteran who played key roles in the development of four marketed drugs, including two blockbusters, further added that “This is a very dynamic time for Kinex as we continue to transition from a Drug Discovery company into a vertically integrated Discovery/Development organization. We have successfully navigated KX2-391 through the IND process, and have positioned the company to continue to develop the necessary pipeline to go public in the next few years”.
Phase 1 trials on KX2-391 will begin at two prominent U.S. Cancer Centers, in September 2007 in patients with lymphoma or solid tumors. The goal of these studies is to generate human safety data and to look at potential efficacy using biomarkers.
KX2-391 is an orally active Src kinase inhibitor with excellent bioavailability. It is a first-in-class drug because it is the first non-ATP competitive kinase inhibitor to enter human trials, thereby providing a highly selective mechanism of action that should have a decreased likelihood of inducing resistance in patients. Src kinase is a key regulator of tumor growth, tumor vascularization and metastasis. In pre-clinical animal models, KX2-391 inhibits the growth of both primary tumors and metastasis. The compound is a potent inhibitor of a wide range of human tumor cells, including cells that are resistant to currently available cancer therapies.