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MediVector begins phase III study of favipiravir for influenza
Boston | Monday, January 20, 2014, 18:00 Hrs  [IST]

MediVector, Inc. has enrolled its first patient in the United States in one of two FAVOR favipiravir phase III studies in adults with uncomplicated influenza.  This multi-centre, double-blind, placebo-controlled study is expected to enroll over 1,000 patients in participating clinics and practices in North, Central, and South America.

"The burden of seasonal influenza is substantial, resulting in hundreds of thousands of deaths each year worldwide. We see the potential for this drug to serve a crucial public health need," Dr Carol Epstein, executive vice president and chief medical officer of MediVector, Inc. said. "With illness and death from pandemic flu an ever present threat, the importance of new drugs, like favipiravir, become more and more significant. Many strains of influenza have developed resistance to currently-available drugs."

The phase III FAVOR study follows the successful completion of a phase II, multi-center, double-blind, placebo-controlled study in the United States with favipiravir in patients with uncomplicated influenza. In the phase II study, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of six influenza symptoms consistent with uncomplicated influenza (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue). In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir appeared safe and well tolerated with no serious adverse events reported during this study.

The investigational drug candidate (favipiravir) is being developed by BioDefense Therapeutics (BD Tx), a joint product manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Programme Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide US military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation's biodefense response capability.

MediVector, Inc. is a drug development company focused on developing innovative therapeutic agents using streamlined processes to address unmet medical needs and improve public health.

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