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news.Cylene Pharmaceuticals, a biotechnology company, has initiated a Phase I clinical trial of its oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, Castleman's disease, or multiple myeloma.
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The primary endpoints of the oral dose escalating trial are determination of safety, tolerance and pharmacokinetic properties of CX-4945 and to select the appropriate dose for Phase II trials.
In addition, multiple mechanism-related pharmacodynamic biomarkers that were validated in preclinical studies will also be evaluated in the trial to assess the ability of CX-4945 to hit its target in patients.
In this Phase I trial, CX-4945 will be administered to patients orally twice a day, for three consecutive weeks of a four week cycle, over a range of doses. The primary objectives of the study will be to determine the maximum tolerated dose and dose limiting toxicities of CX-4945, and to define the Phase II dose.
The secondary objectives are to characterize the pharmacokinetics, as well as observe for signs of anti-tumor activity via pharmacodynamic as well as radiographic assessments.
William Rice, president and CEO of Cylene, said: CX-4945 represents the first potent and selective inhibitor of CK2 with a favorable safety profile and the ability to promote tumor regressions as a single agent in preclinical studies. We are delighted to have advanced CX-4945 into the clinic ahead of schedule, and we are thoughtfully planning our Phase II program in particular CK2 driven cancers.