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Ono and Medarex Announce Allowance of Investigational New Drug Application for Fully Human Anti-PD1 Antibody
Date:10/29/2007

Addition of Hepatitis C Treatment to Ongoing Oncology Program for MDX-1106

PRINCETON, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Ono Pharmaceutical Co., Ltd. and Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody being investigated for the treatment of chronic viral infections, with the first trial to target hepatitis C. 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.

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 1 infection (HCV). The study is intended to evaluate the safety, pharmacokinetics, and preliminary efficacy of single doses of MDX-1106/ONO- 4538.

"Recently, involvement of PD-1 in hepatitis C has been reported in the scientific literature," said Shozo Matsuoka, Ph.D., Senior Managing Director of Ono Pharmaceutical, Co., Ltd. "ONO-4538/MDX-1106 aims to improve the immune capacity of the body and treat hepatitis C with a novel mechanism of action which inhibits the involvement of PD-1. We are seeking to develop ONO- 4538/MDX-1106 to be a new treatment for hepatitis C."

"We value our partnership with Ono and are pleased with the progress to study the potential of MDX-1106 in both oncology and infectious diseases," said Howard Pien, President and CEO of Medarex. "We believe that our ongoing program in patients
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SOURCE Medarex, Inc.
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