Press Release

Replicor updates clinical results demonstrating the achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139.

10 November 2012, Boston, U.S.A. and Nanjing, China.

Friday , November 9th, 2012 – Replicor is currently undertaking a proof of concept trial in patients with chronic hepatitis B (HBV) undergoing treatment with its nucleic acid polymer (NAP) REP 2139 in combination with Zadaxin™ or Pegasys™. The hepatitis B surface antigen protein (HBsAg) is produced in large excess by the HBV infection as subviral particles (SVPs) which act to block the immune response to HBV infection. NAPs act to block the release of SVPs from infected hepatocytes, providing an effective method for clearing HBsAg from the blood. The elimination of HBsAg in the blood of HBV-infected patients is well known to be the best indicator of a curative response to treatment.

Updated interim results from Replicor’s proof of concept trial will be disclosed simultaneously on Nov 10, 2012 at the 63rd annual meeting of the American Association for the Study of Liver Disease (AASLD) in Boston, U.S.A. and at the 10th annual meeting on International Drug Discovery Science and Technology in Nanjing, China.

Patients who had cleared HBsAg from their blood with REP 2139 monotherapy were subjected to combination treatment with REP 2139 and either Pegasys™ or Zadaxin™. Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. In 8 out of 9 patients who have achieved this therapeutic vaccine-like response, they continue to control their viral infection off treatment. Replicor expects that short term Zadaxin™ or Pegasys™ treatment given in combination with the HBsAg release inhibitor REP 9AC’ will achieve an effective, therapeutic vaccination in patients with chronic HBV infection, resulting in the achievement of durable immunological control in most patients, regardless of viral genotype or state of their HBV infection.

For the 63rd annual meeting of the American Association for the Study of Liver Disease:
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For the 10th annual meeting on International Drug Discovery Science and Technology:
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