Full enrolment achieved for BV Phase 2 trial and first Phase 3 trial
25 June 2012
Melbourne, Australia: Starpharma Holdings Ltd (ASX:SPL; OTCQX: SPHRY) is pleased to report that recruitment is now 100% complete for its Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV, and also for the first of two pivotal Phase 3 studies of VivaGel® for the treatment of BV.
Key Points:
- Recruitment 100% complete for VivaGel® Phase 2 prevention study for bacterial vaginosis (BV)
- Recruitment for two pivotal Phase 3 BV treatment studies proceeding rapidly with enrolment of the first trial now 100% complete
- Phase 3 treatment trials and the Phase 2 prevention trial all expected to complete in 2H CY2012.
- Activities to support NDA submission, including manufacturing scale up and validation, well advanced