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Epiphany Biosciences Initiates Program to Assess Valomaciclovir (EPB-348) as Adjunctive Therapy in Multiple Sclerosis (MS)
Date:3/24/2009

SAN FRANCISCO, March 24 /PRNewswire/ -- Epiphany Biosciences announced today that the company plans on filing an IND with the Food and Drug Administration (FDA) to study the potential impact of using the antiviral medication valomaciclovir (EPB-348) as an adjunctive therapy in the treatment of multiple sclerosis.

Valomaciclovir has been shown to possess potent antiviral activity in vitro against a number of herpes-related viruses, including herpes simplex (HSV), Epstein-Barr virus (EBV), herpes zoster (HZV), and human herpes virus 6 (HHV-6). The drug is currently being tested in a phase 2b study in patients with acute herpes zoster infection (shingles) and in a phase 2a study in patients with acute infectious mononucleosis.

"There has been accumulating evidence that MS may be the result of multiple contributing factors, including infection by the Epstein-Barr virus," stated Fred Volinsky, MD, CEO of Epiphany. "Based on these data, we feel this is the right time to explore the potential use of valomaciclovir to help manage this illness that can affect young adults as well as children."

Multiple sclerosis is a chronic, and often progressive demyelinating illness of the central nervous system, occurring with a noted predominance among women. "MS affects approximately 2.5 million people worldwide and appears to result from an interplay between genetic and environmental factors which taken together, increase a person's likelihood of developing the disease. MS is also increasing in frequency worldwide. Some progress in managing the symptoms of MS has been achieved with the use of immunomodulatory therapies. This program would be the first foray into potentially augmenting immunomodulatory therapeutics with a medicine specifically targeted at a suspected infectious cause, the Epstein-Barr virus," commented Stephen Hauser, MD, Chair of the Department of Neurology at the University of California, San Francisco and recent recipient of John Dystel Prize awarded jointly by the American Academy of Neurology and the National MS Society for his work in the field of MS research.

"We plan to conduct viral and pharmacokinetic studies prior to the use of valomaciclovir in longer term studies in patients with MS. Valomaciclovir has exhibited a sound safety profile to date with dosages ranging from one gram to three grams daily," reports Brian Murphy, MD, Chief Medical Officer of Epiphany. "We feel that ultimately, a combination approach, especially one that would involve antiviral pharmacologic pressure on the suspected viral component of the disease, could provide patients with better long-term management, especially if coupled with immunomodulatory agents that may cause transient leukopenia."

About Epiphany Biosciences

Epiphany Biosciences is a privately-held company developing therapeutic products and diagnostic technologies that treat or help prevent the spread of pathogenic viruses, including varicella virus (VZV), Epstein-Barr Virus (EBV) and hepatitis C virus (HCV).

Contact: Fred Volinsky of Epiphany Biosciences, 415-765-7193, volinsky@epiphanybio.com


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