BUFFALO, N.Y., July 20 /PRNewswire/ -- 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.
About Kinex Pharmaceuticals
Kinex Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of novel non-ATP competitive small molecule inhibitors for therapeutically relevant tyrosine kinases and phosphatases. Mimetica(TM), the Company's platform discovery technology is used to design and synthesize orally bioavailable small molecules that are highly selective for their target. This technology was originally developed in the laboratory of Dr. David Hangauer at the University of Buffalo; Kinex has an exclusive world-wide license to Mimetica(TM) and to early compounds which formed the basis for the KX2-391 development program.
In addition to KX2-391, Kinex is currently developing Src inhibitors for ophthalmic indications and hearing loss. Discovery programs are focused on the use of Mimetica(TM) and the Company's compound libraries to identify lead compounds for cancer and other medical conditions where unmet medical needs exist.
Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties. Kinex may not actually achieve the plans, intentions or expectations contained in such forward-looking statements. Actual results or events could differ materially from plans, intentions and expectations contained in such forward-looking statements. Kinex does not assume any obligation to update any such forward-looking statements. For further information on Kinex Pharmaceuticals, please visit http://www.kinexpharma.com or contact Lyn M. Dyster, Ph.D., Vice President of Operations at 716.881.8984
Kinex PharmaceuticalsCONTACT: Lyn M. Dyster, Ph.D., Vice President of Operations of KinexPharmaceuticals, +1-716-881-8984
Web site: http://www.kinexpharma.com/
