Based on this phase II dose-ranging study and in line with the company’s product development strategy to best prepare for its phase III study, Nabi will next conduct a full phase II proof-of-concept study.
The phase II dose-ranging study was designed to assess tolerability and antibody response of the vaccine at higher doses than those used in previous studies; the results showed that NicVax was well tolerated.
Nabi has also met with the FDA, as well as the European Medicines Agency (EMEA), to ensure all key regulatory requirements are built into the NicVax phase II trial design and overall development program.
Enrollment in the proof-of-concept phase II study will commence during the second quarter of 2006 and will be comprised of approximately 210 patients, a large enough sample size to establish both proof-of-concept and optimal dose identification for its phase III program. The study results are anticipated in the second half of 2007.
“We have generated positive results to date for NicVax, garnered important scientific evidence to support NicVax’s mechanism of action, hold strategically important patents in major global markets, and will have in place a good body of clinical data that will be aligned with our phase III protocol,” stated Thomas McLain, chairman, CEO and president, Nabi Biopharmaceuticals.