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news.Nereus Pharmaceuticals has initiated a phase I clinical trial to evaluate the safety and tolerability of NPI-2358, a novel, small molecule tumor vascular disrupting agent for the treatment of patients with solid tumors.
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The open label, single-agent study will be conducted at two centers with well known expertise in developing new oncology drugs: the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan, and the CTRC Institute for Drug Development in San Antonio, Texas.
Trial participants will receive once-weekly, intravenous doses of NPI-2358, which will be escalated to determine maximum tolerated dose. Other objectives include tumor response, pharmacokinetic and pharmacodynamic analyses. The trial is expected to enroll approximately 35 patients.
In preclinical models of cancer, including breast, sarcoma, colon and prostate, NPI-2358 demonstrated it is a potent and selective tumor vascular disrupting agent (VDA). The drug exhibits its effects by interacting at the colchicine-binding site on microtubules provoking a rapid collapse and occlusion of established vasculature in the tumor, which induces tumor cell death, leading to necrosis.
“Preclinical studies involving various solid tumors demonstrate NPI-2358 selectively destroys vasculature in the central portion of tumors, shrinking the malignant mass,” explained Dr Anthony Tolcher, principal investigator and director of clinical research at the CTRC Institute for drug development. “I look forward to continuing to investigate this new generation of VDAs in this clinical trial.”