MediVector, Inc. Announces the Successful Initiation of Its Phase 3 Program for the Investigational Influenza Drug
BOSTON, MA, USA I January 16, 2014 I MediVector, Inc. today announced the enrollment of its first patient in the United States in one of two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza. This multi-center, 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 3 FAVOR study follows the successful completion of a Phase 2, multi-center, double-blind, placebo-controlled study in the United States with favipiravir in patients with uncomplicated influenza. In the Phase 2 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 Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. 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. For more information, visit www.jpeocbd.osd.mil.
About MediVector, Inc.
MediVector, Inc. is a Boston-based drug development company focused on developing innovative therapeutic agents using streamlined processes to address unmet medical needs and improve public health.
About Favipiravir
Favipiravir (originally known by the code name, T-705) is a novel anti-viral compound that works against a different viral enzyme target than approved antiviral agents used to treat people who have become ill with influenza. Favipiravir inhibits the enzyme viral RNA polymerase that functions to make copies of the viral RNA segments and to synthesize mRNAs that produce the proteins that will form new viruses. Favipiravir may be useful for the treatment of influenza infections based on its potent and selective inhibitory activities against a broad spectrum of influenza A, B, and C viruses, including strains poorly susceptible to existing drugs and its efficacy against highly pathogenic avian influenza and avian influenza virus A (H5N1) isolated from humans and birds in both in vivo and in vitro studies. Preclinical studies indicate that favipiravir may also be effective against a variety of other viral illnesses.
SOURCE: MediVetcor
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MediVector, Inc. Announces the Successful Initiation of Its Phase 3 Program for the Investigational Influenza Drug
BOSTON, MA, USA I January 16, 2014 I MediVector, Inc. today announced the enrollment of its first patient in the United States in one of two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza. This multi-center, 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 3 FAVOR study follows the successful completion of a Phase 2, multi-center, double-blind, placebo-controlled study in the United States with favipiravir in patients with uncomplicated influenza. In the Phase 2 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 Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. 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. For more information, visit www.jpeocbd.osd.mil.
About MediVector, Inc.
MediVector, Inc. is a Boston-based drug development company focused on developing innovative therapeutic agents using streamlined processes to address unmet medical needs and improve public health.
About Favipiravir
Favipiravir (originally known by the code name, T-705) is a novel anti-viral compound that works against a different viral enzyme target than approved antiviral agents used to treat people who have become ill with influenza. Favipiravir inhibits the enzyme viral RNA polymerase that functions to make copies of the viral RNA segments and to synthesize mRNAs that produce the proteins that will form new viruses. Favipiravir may be useful for the treatment of influenza infections based on its potent and selective inhibitory activities against a broad spectrum of influenza A, B, and C viruses, including strains poorly susceptible to existing drugs and its efficacy against highly pathogenic avian influenza and avian influenza virus A (H5N1) isolated from humans and birds in both in vivo and in vitro studies. Preclinical studies indicate that favipiravir may also be effective against a variety of other viral illnesses.
SOURCE: MediVetcor
Post Views: 97
