September 9, 2008
Epiphany Biosciences to Continue Phase 2 Shingles Study After Interim Analysis
SAN FRANCISCO, Sept. 9 /PRNewswire/ -- Epiphany Biosciences, Inc. today announced that a Phase 2b dose-ranging study to evaluate the safety, efficacy, and tolerability of the company's lead compound, valomaciclovir (EPB-348) in patients with acute herpes zoster infection (shingles), will continue as originally designed following an interim analysis.
Fred Volinsky, MD, Epiphany's CEO said, "We are pleased with the progress of this clinical trial and look forward to the final data. If successful, valomaciclovir will mark an advance in the treatment of herpes zoster which affects more than two million people annually around the globe. As the world population ages, it is expected that the incidence of this disease will grow significantly, especially in lieu of the lackluster response to vaccines in this area. We look to valomaciclovir to enhance the treatment experience by being the first once-daily therapy for shingles." The Phase 2b study is being conducted at sites throughout North America and uses an active comparator, valacyclovir. Outcomes assessed include various efficacy parameters including time to vesicular resolution and safety data collection.In addition to the Phase 2b zoster study, valomaciclovir will also be studied in a separate Phase 2 clinical trial as a therapy in managing the most severe sequelae of a herpes-zoster infection, post-herpetic neuralgia or PHN. "The spectrum of disease caused by herpes viruses is underappreciated but a disease like shingles can have a profound impact on the quality-of-life of patients, many times leading to severe pain syndromes that could have a viral etiology. We look forward to examining the clinical utility of valomaciclovir in multiple conditions associated with herpes viruses and plan to maximize the broad-acting antiviral profile of this drug," reported Brian Murphy, MD, Chief Medical Officer of Epiphany.
In addition to the studies directed at herpes zoster, valomaciclovir is also being studied in a Phase 2 trial of acute infectious mononucleosis, a syndrome commonly seen in adolescents and young adults, caused by Epstein-Barr virus (EBV), also a member of the herpes virus family. "Further studies of valomaciclovir outside herpes zoster are warranted and we plan to examine uses of this drug in major diseases associated with EBV," commented Dr. Murphy.
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).
Fred Volinsky, CEO
415 765 7193
Epiphany Biosciences, Inc.
CONTACT: Fred Volinsky, CEO of Epiphany Biosciences, Inc.,+1-415-765-7193
Web site: http://www.epiphanybio.com/