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news.Kinex Pharmaceuticals has initiated 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.
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KX2-391 is an inhibitor of Src kinase signaling and microtubule polymerisation 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.
The Phase 2 single-arm study is expected to 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.
Allen Barnett, chief executive officer of Kinex, said: “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.”