Prothena Corporation, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that the first patient with Parkinson's disease has been successfully dosed in a Phase 1 multiple ascending dose clinical trial of PRX002, a potential disease-modifying treatment for Parkinson's disease. This study builds upon an ongoing Phase 1 single ascending dose study initiated in April 2014 designed to evaluate PRX002 in healthy volunteers.
This Phase 1 randomized, double-blind, placebo-controlled, multiple ascending dose study of PRX002 was initiated based upon safety and tolerability observed to date in the ongoing study in healthy volunteers, and is expected to enroll up to 60 patients with Parkinson's disease at multiple centers across the United States. The multiple ascending dose escalation trial is designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRX002, and will also evaluate multiple clinical and exploratory biomarkers. Patients will be enrolled in escalating dose cohorts of PRX002 or placebo and will be observed for up to 6 months.
"We are extremely pleased to initiate this study of PRX002 in patients with Parkinson's disease," said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "Building on our robust preclinical studies that demonstrated targeting α-synuclein led to both functional and cognitive improvement in animal models of Parkinson's disease, together with Roche, we are excited for the opportunity to assess PRX002 in patients with Parkinson's disease."
This study, like the one from AffiRis, is another indication of the potential importance of targeting misfolded a-Syn with antibodies to slow, or halt, PD progression.
http://ir.prothena.com/releasedetail...leaseID=863495
07-31-2014, 08:33 PM
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