Adamas Pharmaceuticals, Inc.,a privately held company, announced today that it has expanded its Phase 2clinical study of a proprietary investigational triple-combination antiviraldrug therapy for influenza to include centers in the United States, Canada andEurope. The study, which was initiated in August 2009 in the SouthernHemisphere, is designed to investigate Adamas' triple combination antiviraldrug (TCAD) therapy as a treatment for influenza A, including novel influenzaA/H1N1, the cause of the current flu pandemic. TCAD therapy consists ofAdamas' proprietary combination of amantadine and ribavirin administeredadjunctively with a neuraminidase inhibitor such as oseltamivir. The study isdesigned to assess the ability of TCAD therapy to suppress replication of theinfluenza A virus, alleviate symptoms from subjects and impede the developmentof resistance.
"Immune-compromised patients are at increased risk for life-threateningcomplications from influenza infection, and therefore the development of abroad-spectrum anti-influenza treatment is critical for this underservedpopulation," said Gregory Went, Ph.D., Chief Executive Officer and Chairman ofAdamas. "We have accelerated our development efforts to generate clinical datathat demonstrate how TCAD therapy can address the needs of influenza patientsin light of the prevalence of novel influenza A/H1N1 flu this season andgrowing concerns about the emergence of antiviral resistance during treatmentwith single neuraminidase inhibitors like oseltamivir."
The study, AAVID-1(TM) (Adamas Antiviral Influenza Drug), is a Phase 2,open-label, randomized study that will enroll during the 2009/10 influenzaseason up to 250 immune-compromised adults and children with influenza A in upto 45 study sites. The study's primary endpoint is the time to clearing ofviral shedding. Study participants will include patients ages one to 65 whoare immune-compromised due to receiving chemotherapy or immunosuppressivemedications, or who are HIV positive. The protocol calls for studyparticipants to be randomized to receive either the TCAD therapy comprised ofamantadine and ribavirin with oseltamivir or oseltamivir monotherapy for 10days. The follow-up period will be six months following treatment and anIndependent Data Monitoring Committee will monitor the safety of participantsthroughout the duration of the study.
"There is a clear need for alternative antiviral strategies to treatinfluenza, especially for immune-compromised patients at risk for developmentof drug resistance and severe clinical outcomes," said Menno de Jong, M.D.,Ph.D., professor in Clinical Virology at the Department of MedicalMicrobiology, Academic Medical Centre of the University of Amsterdam, andChair of the Protocol Steering Committee for this Phase 2 trial. "Based onpreclinical results showing that Adamas' triple combination of amantadine,ribavirin, and oseltamivir is synergistic in its ability to block replicationof the influenza virus, I believe Adamas' approach has much potential, andlook forward to being involved in this study."