BiondVax Plans Phase 3 Clinical Trial Following Receipt of Scientific Advice from the European Medicines Agency (EMA)
NESS ZIONA, Israel, Dec. 27, 2017 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) announced today that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed BiondVax's Phase 3 trial plan, provided advice, and allowed the Company to proceed with the Phase 3 clinical trial plan for M-001, BiondVax's universal flu vaccine candidate. The CHMP advice will facilitate procedures in the countries where the Phase 3 study will take place.
The CHMP response states that, "It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval."
Dr. Tamar Ben Yedidia, BiondVax's Chief Science Officer noted, "According to our expert European advisors, the CHMP accepts the entire approach in general and the study design in particular. This means BiondVax can proceed to Phase 3 as planned."
Dr. Ron Babecoff, CEO of BiondVax, commented, "I wish to thank the EMA's CHMP for their thoughtful and informative advice which we are incorporating into BiondVax's pivotal Phase 3 trial plan."
Babecoff continued, "There is a clear need to improve upon current flu vaccine technologies, as noted in the recent New England Journal of Medicine article titled Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine.[1] BiondVax's Universal Flu Vaccine candidate is designed to address challenges of current flu vaccines such as mismatches, mutations, and long production lag. With six completed successful human clinical trials, we are excited to proceed to a pivotal clinical efficacy Phase 3 trial with M-001 as a universal flu vaccine."
The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enrol a total of 7,700 participants over two years. Since assessment of clinical efficacy of influenza vaccines largely depends on the attack rates of circulating influenza strains, the study features flexible enrollement to adjust the required number of participants in year 2. The participants will be aged 50 years and older, with at least half over 65 years of age.
The trial is expected to take place in Eastern Europe and begin prior to the 2018/19 flu season.
