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news.The FDA has allowed an investigational new drug application from Ono Pharmaceutical and Medarex for a fully human anti-PD-1 antibody being investigated for the treatment of chronic viral infections, with the first trial to target hepatitis C.
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The new Phase I single-dose, dose-escalation trial with MDX-1106 (ONO-4538) is expected to enroll up to 34 patients with active hepatitis C genotype I infection (HCV).
The study is intended to evaluate the safety, pharmacokinetics and preliminary efficacy of single doses of MDX-1106. MDX-1106 was developed under the May 2005 collaborative research agreement between Ono and Medarex, and currently is in a separate ongoing Phase I clinical study in patients with recurrent or treatment-refractory cancer.
Preclinical studies suggest that blockade of the PD-1 signaling pathway by MDX-1106, a fully human anti-PD-1 antibody, activates T-cell responses and promotes an immune response to fight tumors and infectious diseases. Medarex and Ono Pharmaceutical will continue to investigate the potential of MDX-1106 for cancer in an ongoing Phase I clinical trial and for hepatitis C, the companies said.