Herald Sun: Starpharma in prime position for growth
Herald Sun Business Journalist John Beveridge examines Starpharma’s success in reaching commercial milestones and recruiting participants for its VivaGel trials in his In the Black column.
‘Three pivotal clinical trials are now almost completely stocked with test subjects, primarily to check the effectiveness of Starpharma's VivaGel at preventing and treating the common disorder bacterial vaginosis.
These trials are at the very sharp end of proceedings - phase two and phase three before the US Food and Drug Administration - and results should be in before Christmas.
That puts Starpharma chief executive Dr Jackie Fairley in a strong position to negotiate a lucrative deal next year with a large pharmaceutical partner to add marketing and distribution muscle to some excellent Australian-developed science.’
Full enrolment achieved for BV Phase 2 trial and first Phase 3 trial
- 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
Starpharma's VivaGel Phase 3 treatment trials 60% enrolled
Key points
- > Enrolment passes 60% for VivaGel® Phase 3 BV treatment trials
- > Trials well on track for completion in 2012
- > One of the trials has already enrolled more than 80% of subjects