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Epiphany Biosciences Reports Initiation of Phase 2 Study of Valomaciclovir for the...

Thu Dec 6, 2007 4:04pm EST
Epiphany Biosciences Reports Initiation of Phase 2 Study of Valomaciclovir for
the Treatment of Acute Infectious Mononucleosis

SAN FRANCISCO, Dec. 6 /PRNewswire/ -- 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
information on Epiphany Biosciences may be obtained at the company website
http://www.epiphanybio.com or by contacting company representatives: Fred G.
Volinsky MD, CEO 415.765.7193
SOURCE  Epiphany Biosciences Inc.

Fred G. Volinsky MD, CEO of Epiphany Biosciences Inc., +1-415-765-7193



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