MADISON, Wis.–(BUSINESS WIRE)–FluGen Inc., a clinical-phase biopharmaceutical business focused on the discovery and progression of much more efficient influenza vaccines, today announced the initiation of the very first Phase 1 clinical trial of its RedeeFlu™ universal influenza vaccine. The trial is a randomized, blinded, dose-ranging Phase 1 study of the H3N2 RedeeFlu™ influenza vaccine in 96 healthy and balanced adult subjects between 18 and 49 years of age. Along with the trial’s primary target of evaluating the safety of the vaccine in this population, the study likewise will certainly evaluate the 2 antibody and T-cell responses induced by the vaccine.
“The initiation of this very first in man study is an vital milestone accomplished through the research and progression efforts of the FluGen group and our collaborators. We believe that RedeeFlu™ could be the very first influenza vaccine to reveal robust protection from drifted or mismatched flu strains,” said Paul V. Radspinner, President & CEO.
During the 2014-15 flu season in the US, the picked vaccine strain was various compared to the “drifted” circulating virus. As a result, the existing flu vaccines had dramatically low efficacy. Throughout the 2015-16 flu season questions have actually been raised concerning the effectiveness of live attenuated influenza vaccines. The RedeeFlu™ vaccines are novel, M2-deleted solitary replication (M2SR) viruses that promptly induce antibody and cellular immune responses like wild type influenza, yet cannot develop infectious virus. In multiple preclinical models, RedeeFlu™ (M2SR) vaccines have actually demonstrated superior protection versus the 2 drifted and permanently mismatched strains of influenza once compared to others live or inactivated influenza vaccine technologies. RedeeFlu™ vaccines likewise have actually protected versus influenza in older pet dogs and in the face of pre-existing immune responses.
“The majority of of the morbidity and mortality associated along with influenza is endured by young kids and older adults,” said Dr. Dan Stinchcomb, Executive Chairman. “This trial is the very first step in a clinical progression strategy made to assess the safety of H3N2 RedeeFlu™ (M2SR) and to demonstrate the breadth of protection in multiple age groups. If our preclinical outcomes are reproduced in human clinical studies, RedeeFlu™ (M2SR) could satisfy a considerable global good health need.”
Additional short article concerning the Phase I clinical trial can easily be discovered under ClinicalTrials.gov identifier NCT02822105.
About Influenza
Influenza (flu) is a contagious respiratory ailment caused by influenza viruses. The influenza virus is transmitted easily from individual to individual via droplets and small particles made once infected people cough or sneeze. Influenza tends to spread promptly in seasonal epidemics. Infection usually lasts for concerning a week, and is characterized by sudden onset of higher fever, aching muscles, headache and significant malaise, non-productive cough, sore throat and rhinitis. Some people are at higher risk for significant flu complications, including the elderly, young children, pregnant women, and people along with certain good health conditions such as asthma, chronic lung disease, diabetes, heart disease, blood, kidney or lung disorders, or weakened immune systems. Worldwide, it is estimated that 3 to 5 million cases of significant influenza and 250,000 to 500,000 influenza-related deaths occur every year.
About FluGen, Inc.
FluGen, Inc. is a privately held biotechnology business founded in 2005 and based in Madison, WI. The business has actually been producing novel influenza vaccine technology very first invented at the University of Wisconsin-Madison, in the laboratories of Dr. Yoshihiro Kawaoka and Dr. Gabriele Neumann, and exclusively licensed to FluGen by WARF. The RedeeFlu™ influenza vaccine contains mutations in the M2 gene of the virus. The mutated virus can easily infect cells, express the entire spectrum of influenza RNA and proteins, yet fails to develop any kind of infectious virus particles. Thus, the vaccine does not lose infectious virus and does not trigger any kind of pathological signs of infection. In multiple pet models, RedeeFlu™ is safe yet sets off robust innate, antibody and cellular immune responses that can easily protect versus “drifted” or also mismatched influenza strains. The business is producing RedeeFlu™ to treat two unmet calls for in the prevention of human influenza: much better protection versus influenza in the elderly and much better protection versus drifted influenza strains that can easily trigger influenza epidemics. much more short article is readily available at www.flugen.com.
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