The study, AAVID-1(TM) (Adamas Antiviral Influenza Drug), is a Phase 2, open-label, randomized study that will enroll during the 2009/10 influenza season up to 250 immune-compromised adults and children with influenza A in up to 45 study sites. The study's primary endpoint is the time to clearing of viral shedding. Study participants will include patients ages one to 65 who are immune-compromised due to receiving chemotherapy or immunosuppressive medications, or who are HIV positive. The protocol calls for study participants to be randomized to receive either the TCAD therapy comprised of amantadine and ribavirin with oseltamivir or oseltamivir monotherapy for 10 days. The follow-up period will be six months following treatment and an Independent Data Monitoring Committee will monitor the safety of participants throughout the duration of the study.

"There is a clear need for alternative antiviral strategies to treat influenza, especially for immune-compromised patients at risk for development of drug resistance and severe clinical outcomes," said Menno de Jong, M.D., Ph.D., professor in Clinical Virology at the Department of Medical Microbiology, Academic Medical Centre of the University of Amsterdam, and Chair of the Protocol Steering Committee for this Phase 2 trial. "Based on preclinical results showing that Adamas' triple combination of amantadine, ribavirin, and oseltamivir is synergistic in its ability to block replication of the influenza virus, I believe Adamas' approach has much potential, and look forward to being involved in this study."

SOURCE Adamas Pharmaceuticals, Inc.