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Kinex Pharmaceuticals Initiates a Phase 2 Clinical Trial of KX2-391 in Patients with Prostate Cancer

BUFFALO, N.Y., Feb. 25 /PRNewswire/ --  Kinex Pharmaceuticals opened a Phase 2 clinical trial to evaluate the safety and efficacy of KX2-391 in patients with bone-metastatic, castrate-resistant prostate cancer (CRPC) who have not had prior chemotherapy.  

The study will take place at the University of Chicago, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, the University of Wisconsin (Madison), the University of Washington (Seattle) and at Wayne State University. The lead Principal Investigator for the study is Dr. Michael Carducci from Johns Hopkins University.  

The Phase 2 single-arm study will enroll approximately 50 patients with progressive prostate cancer who will receive orally administered KX2-391 twice-daily for 24 weeks.  The primary endpoint of the study is to determine the number of patients who do not have clinical or radiographic progression after 24 weeks of treatment.  Approximately 70% of patients with progressive bone-metastatic prostate cancer who do not undergo treatment, will progress within 24 weeks.  The ability of KX2-391 to improve the outcome of CRPC patients who do not elect to be treated by chemotherapy will be determined.

KX2-391 is an inhibitor of Src kinase signaling and microtubule polymerization and has a broad range of activity in cancer cell lines, including those that are resistant to commonly used chemotherapeutic agents.  Preclinical studies have highlighted the ability of KX2-391 to inhibit the proliferation and metastasis of prostate cancer cell lines in mouse xenografts.

"Based on its mechanism of action and on Phase 1 clinical data, we expect KX2-391 to benefit men with CRPC.  This drug is well tolerated and provides an option for patients who do not want to proceed to chemotherapy," said Dr. Allen Barnett, Chief Executive Officer of Kinex Pharmaceuticals.

About Kinex Pharmaceuticals

Kinex is a Buffalo, NY based, privately held biopharmaceutical company committed to the discovery and development of novel therapeutics. The Company's platform technologies, Mimetica™ and Opal™, provide unique insight into the design and synthesis of target-based small molecule inhibitors that selectively act on proteins that play key roles in cancer and immuno-inflammatory diseases.

KX2-391 is currently being studied in a Phase 2 clinical trial in prostate cancer patients; additional Phase 2 oncology studies will commence later in 2010. KX2-361 is being developed for brain cancer; an IND is expected during the 4th quarter of 2010. In addition, Kinex is developing several other new product candidates that inhibit key immuno-inflammatory pathways.

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