Kinex Pharmaceuticals: KX2-391 Enters Phase 1 Clinical Trials for Oncology

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October 30, 2007
KX2-391 Enters Phase 1 Clinical Trials for Oncology

Kinex Founders: left to right, Lyn M. Dyster, Ph.D., Allen Barnett, Ph.D. and David G. Hangauer, Ph.D.

Kinex Pharmaceuticals has announced that its oncology drug, KX2-391, has entered Phase 1 clinical trials. The study is entitled “A combined rising single-dose (RSD) and rising multiple-dose (RMD) Phase 1 study to evaluate safety, tolerability and pharmacokinetics of KX2-391 in patients with advanced malignancies that are refractory to conventional therapies”. The study commenced on October 29, 2007 at Roswell Park Cancer Institute (RPCI) in Buffalo, New York and will be led by Alex Adjei, M.D., Ph.D., Senior Vice President of Clinical Research and Chair of the Department of Medicine. Enrollment at a second site is expected to commence by mid-November, 2007.

KX2-391 is a highly selective Src kinase inhibitor that has demonstrated efficacy in pre-clinical animal models of colon, pancreatic, prostate and breast cancer. “We are particularly excited about the clinical prospects for KX2-391 because this is the first substrate-targeted kinase inhibitor to enter clinical trials and is expected to have improved efficacy with reduced toxicity”, said David Hangauer, Ph.D., Senior Vice President of Research and Development at Kinex Pharmaceuticals and one of the Company’s founders. The Phase 1 study is expected to enroll 50 patients and last approximately one year. In addition to evaluating safety, tolerability and pharmacokinetics, exploratory biomarker studies will also be involved.

Dr. Allen Barnett, Chief Executive Officer of Kinex Pharmaceuticals said “This is the first potential block-buster drug to be generated from our platform technology and we expect KX2-391 to be followed in the short term with additional compounds that are currently in pre-clinical development”. Barnett, a veteran of the pharmaceutical industry led discovery efforts at Schering-Plough that resulted in several marketed drugs including the blockbusters Claritin and Zetia.

Mimetica™, Kinex Pharmaceutical’s platform technology was developed in the academic laboratory of Dr. David Hangauer at the University at Buffalo and is exclusively licensed to Kinex. Mimetica™ is a method for designing and synthesizing small molecule substrate-competitive kinase inhibitors. Kinases are the second largest family of drug targets and consequently offer numerous opportunities for developing new drugs to treat cancer, as well as a range of other diseases.