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news.Nereus Pharmaceuticals has initiated a phase I clinical trial designed to evaluate the safety and tolerability of NPI-0052, a novel, small molecule proteasome inhibitor, to treat patients with solid tumors and lymphomas.
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The open label trial is expected to enroll approximately 50 patients with advanced solid tumors or refractory lymphomas at two trial sites – MD Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center.
Participants will receive once-weekly, intravenous doses of NPI-0052, which will be escalated to determine a maximum tolerated dose. Other objectives include tumor response, pharmacokinetic and pharmacodynamic analyses.
NPI-0052 was discovered during the fermentation of Salinispora sp, a new class of marine Gram-positive bacteria identified in sediment from the ocean floor. The compound is a potent inhibitor of human proteasomes, a high interest drug target for pharmaceutical companies after bortezomib (sold as Velcade by Millennium Pharmaceuticals) was approved to treat multiple myeloma in 2003.
Nereus and its collaborators' in vitro and in vivo studies showed NPI-0052 inhibited growth and shrank tumors in various animal models. This activity was enhanced when the drug was combined with biologics and chemotherapeutics.
“The activity of NPI-0052 in preclinical models of lymphomas, myeloma and solid tumors has demonstrated it to be a potent and selective second generation proteasome inhibitor with comparatively durable biological effects that may provide significant advances in the treatment of many cancers,” said Kobi Sethna, president and CEO of Nereus Pharmaceuticals.
Nereus expects to begin a clinical trial for NPI-0052 in patients with multiple myeloma in upcoming months.