12 January 2012 - Australia-based Starpharma Holdings Ltd (ASX:SPL) said on Wednesday it had received a written declaration from the US Food and Drug Administration (FDA) stating its acceptance of the design of the company's Phase III clinical studies of VivaGel for the treatment of bacterial vaginosis (BV).

The Special Protocol Assessment (SPA) through which the FDA accepts the design, goals, statistical analyses and other aspects of the trials, allows the company to move ahead with the final development phase.

As announced earlier, Starpharma intends to initiate the Phase III BV clinical trials in early 2012 and finalise them by the end of the current year. The company plans to seek partners for the product after the close of the Phase III trials.

The two Phase III trials will be performed concurrently and their design, which is now cleared by the US and the European drug regulators, mimics the company's successful Phase II trial of VivaGel for BV treatment.