Finox Biotech Announces First Patients Enrolled in Pivotal US Phase III (FIN3002) study for rFSH Finox Biotech (FINOX AG) announced today that the first patients have been recruited into their pivotal Phase III study in the USA.
Finox Biotech has agreed with the US-FDA to conduct the pivotal phase III study (FIN3002) for registration of bemfola in the USA. FIN3002 is an investigator and assessor-blinded multi-centre study to compare the efficacy and safety of bemfola vs. GONAL-f® in normal ovulatory women undergoing in vitro fertilisation. A total of 1,106 patients undergoing a maximum of three treatment cycles will be enrolled. “The start of FIN3002 is the culmination of discussions with the FDA and leading clinicians and will be one of the largest studies ever conducted in the USA using daily-injected recombinant FSH. We are therefore very excited about the scale of data collection for this study, which will provide a solid platform for our US NDA filing” explained Dr Manfred Rettenbacher, Finox Biotech’s Senior Vice-President, Head of Medical Science. Gavin Jelic-Masterton, CEO of Finox Biotech commented, “Starting this robust and pivotal study in the USA is an important day in the history of Finox Biotech – it means that we are now entering the next phase of the development of the company – which is to produce quality data to enable us to file our product in the world’s largest and most important market for gonadotropins”.back to news