22 December 2024

Starpharma commences pivotal phase 3 VivaGel trials for bacterial vaginosis treatment

Melbourne Australia:  Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced the commencement of two concurrent pivotal phase 3 clinical trials of VivaGel® for the treatment of bacterial vaginosis (BV), following receipt of ethics approval.

Key Points:

  • Two pivotal phase 3 trials launched for the treatment of bacterial vaginosis (BV)
  • Special Protocol Assessment (SPA) already received from the FDA which confirms the design of the planned studies is acceptable to support a New Drug Application (NDA) and marketing approval of VivaGel®
  • Trials to be completed in 2012
  • Preparation of NDA submission and out-licensing discussions to follow

Download ASX Announcement ( pdf file, 193kb)

This contains certain forward-looking statements.

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