BUFFALO, N.Y., June 21 /PRNewswire/ -- Kinex Pharmaceuticals LLC, announced today that the Company has filed its first Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for KX2-391 (KX01), an internally developed small molecule, oral, anticancer product candidate. KX2-391 is a highly selective Src kinase inhibitor that targets the peptide substrate binding site, not the ATP binding site as do all other Src inhibitors commercially available or in development. Because of its unique mechanism of Src inhibition, KX2-391 will be first in class and because of its exceptional selectivity coupled with its robust anti-cancer activity, it will also be potentially best in class.
Src is a target that is important in multiple processes associated with tumor growth and development including proliferation, neo-vascularization and metastasis. In pre-clinical testing, KX2-391 was found to be broad spectrum and very potent in tumor cell lines from all major cancer types. Importantly, KX2-391 was found to potently inhibit certain leukemia cells that are resistant to current commercially available drugs. This included cells derived from chronic leukemia cells with the T3151 mutation. In pre-clinical animal models of cancer, orally administered KX2-391 was shown to inhibit primary tumor growth and also to suppress metastasis. In combination with certain chemotherapeutic agents, KX2-391 was synergistic thereby offering the potential to prescribe lower doses of some current therapies that have undesirable side-effects.
“The unique mechanism of action of KX2-391, affords Kinex Pharmaceuticals the opportunity to develop a novel first-in-class therapy for cancer patients which could make a major contribution to therapy. This compound is the first in a pipeline of novel, selective kinase inhibitors from our Company for the treatment of cancer and other diseases”, said Allen Barnett, Chief Executive Officer of Kinex Pharmaceuticals.
The Phase 1 open-label, dose escalation clinical trial for KX2-391 is planned to begin enrolling patients after IND activation by the FDA. This multi-center U.S. trial will include patients with all types of solid tumors and lymphoma. The trial is designed to measure pharmacokinetic parameters, safety and tolerability of KX2-391 and is projected to begin in September 2007.
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 which will enter Phase 1 clinical trials later this year, 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 Pharmaceuticals LLC
CONTACT: Lyn M. Dyster, Ph.D., Vice President of Operations, of KinexPharmaceuticals LLC, +1-716-881-8984
Web site: http://www.kinexpharma.com//
