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news.Locus Pharmaceuticals is to initiate the first clinical study of its LP-261 orally administered small molecule for the treatment of cancer after the FDA cleared its investigational new drug application.
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LP-261, which is predicted to bind to tubulin in a novel way, was developed by Locus using its proprietary computational drug design capabilities. This drug candidate is distinguished by its anti-tumor and anti-angiogenesis combination mechanism, 100% oral bioavailability and potential to treat resistant tumors.
The protocol for the phase I is now before Institutional Review Boards at the sites selected for the trial and clinical supplies are being prepared. The phase I will be an open-label, dose-escalation study to evaluate the safety and pharmacology of the drug in patients with advanced tumors.
In preclinical studies, LP-261 demonstrated broad anti-tumor activity in vitro and, after oral administration, in vivo, including tumor regression in xenograft models of several major solid tumor types.