Epiphany Biosciences Reports Initiation of Phase 2 Study of Valomaciclovir for the Treatment of Acute Infectious Mononucleosis

Currently there are no approved therapeutics for the treatment for this debilitating condition or any other disease caused by the Epstein-Barr virus

 



SAN FRANCISCO, CA, USA | December 6, 2007 |
Epiphany Biosciences announced today, the initiation of a Phase 2 clinical trial with valomaciclovir (EPB-348) for the treatment and management of acute infectious mononucleosis. Currently, there are no approved therapeutics for the treatment for this debilitating condition or any other disease caused by the Epstein-Barr virus (EBV) “Valomaciclovir has shown a broad spectrum of anti-viral activity, including inhibition of viral replication of herpes zoster and EBV,” said Fred Volinsky, MD, Chief Executive Officer. “EBV has been implicated in a number of chronic and transplant-related diseases. This initial study in acute mononucleosis will set the stage for broader indications involving EBV as an etiologic agent. We are pleased to be working with the University of Minnesota on this important project”.

“EBV is a highly prevalent virus, with up to 95% of middle-aged adults possessing evidence of viral exposure according to CDC surveillance data,” stated Brian Murphy, MD, Chief Medical Officer. “Mononucleosis can severely undermine quality-of-life and the acute EBV infection may lead to other long-term medical sequelae. This double-blind, placebo-controlled, clinical trial will examine fluctuations in viral load as influenced by valomaciclovir as well as assess symptom scores.”

“Our laboratory has found valomaciclovir to be a very potent anti-viral agent against EBV”, reported Dr. Henry H. Balfour, Jr., Professor of Pediatrics and Laboratory Medicine and Pathology at the University of Minnesota, who is
principal investigator for the study. “If this proof of concept study is successful, further large scale studies are warranted. We urgently need a solution for this disease that can severely impact the lives of young adults.”

The acute mononucleosis study at the University of Minnesota will mark the first of several planned studies of valomaciclovir against EBV related diseases.
Comparative anti-EBV potency data were presented by Professor Balfour’s team at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago in September. A manuscript containing
additional data confirming the unique susceptibility of EBV to valomaciclovir will be submitted to a peer-reviewed scientific journal shortly.

About Epiphany Biosciences

Epiphany Biosciences is focused on advancing new therapies for infectious disease. Epiphany is currently conducting a large Phase 2b study examining the safety and efficacy of valomaciclovir against herpes zoster infection.
Epiphany was founded by a world-class virology team, including two Lasker Award winners. Epiphany is located in San Francisco, CA. Additional informationon Epiphany Biosciences may be obtained at the company website
www.epiphanybio.com or by contacting company representatives: Fred G. Volinsky MD, CEO 415.765.7193

SOURCE: EPIPHANY BIOSCIENCES

 

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