The study was a double-blind, randomized, placebo controlled, dose ranging Phase 2 study and was conducted at sites in the US under an Investigational New Drug (IND) application with the US FDA. The study enrolled 132 women who were randomized to receive VivaGel(R) (0.5%, 1% or 3% SPL7013), or placebo. The incidence of adverse events, including genitourinary adverse events, was similar across all placebo gel and VivaGel(R) groups. No severe (grade 3) adverse events were observed in the VivaGel(R) groups. Two severe adverse events were observed in the placebo.
Additional details and results from the study are provided in the Appendix to this announcement.
Addressable global market for BV treatment and prevention potentially exceeds $1B
The global market for topical BV treatments alone is estimated at approximately US$350M. Starpharma's modeling suggests the addressable global market for prevention of recurrence of BV is potentially in excess of $1 billion, due to the long term usage associated with such a product.
Trial results support new patent filing which extends VivaGel(R) protection to at least 2032
On the basis of the data from this phase 2 study, Starpharma has filed a new patent application relating to BV that will, once granted, expand and extend patent protection for VivaGel(R) to at least 2032.
Planning underway for Phase 3 trials for VivaGel(R) for BV treatment
Based on the results of this phase 2 study, Starpharma will undertake further discussions with regulatory authorities, with a view to initiating phase 3 registration trials of VivaGel(R) for the treatment of BV in late 2011 or early 2012.
BV prevention trial of VivaGel(R) to commence Q3 2011
As previously announced Sta
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