Therapy Areas: Vaccines
European Medicines Agency Committee reviews BiondVax Pharmaceuticals' Phase three trial plan for flu vaccine
28 December 2017 -

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has reviewed Israel-based BiondVax Pharmaceuticals Ltd's (Nasdaq: BVXV)(TASE: BVXV) Phase three trial plan, given advice, and allowed the company to proceed with the Phase three clinical trial for M-001, the company's universal flu vaccine candidate, it was reported yesterday.

The CHMP advice will facilitate procedures in the countries where the Phase three study will take place.

The placebo-controlled pivotal clinical efficacy Phase three trial aims to enrol a total of 7,700 participants over two years. Since evaluation of clinical efficacy of influenza vaccines largely depends on the attack rates of circulating influenza strains, the study features flexible enrolment to adjust the required number of participants in year two. The participants will be aged 50 years and older, with at least half over 65 years of age. The trial is likely to take place in Eastern Europe and start prior to the 2018/19 flu season.