The FDA has accepted BiondVax Pharmaceuticals’ (NASDAQ, TASE:BVXV) Investigational New Drug (IND) application for its M-001 vaccine.
The IND continues BiondVax’s clinical program and will allow the company to conduct an FDA-approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax’s product candidate.
In a statement Dr. Ron Babecoff, BiondVax’s CEO, said FDA acceptance of the IND application is an important milestone, representing a major step forward for BiondVax and for the development program of its universal flu vaccine.
BiondVax’s Universal Flu Vaccine (M-001)
Dr. Tamar Ben-Yedidia, CSO, said today’s vaccines are far from ideal – they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness.
“We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year,” he added.
