TORONTO, ONTARIO--(Marketwire -10/06/11)- Trimel Pharmaceuticals Corporation (TSX: TRL.TO - News) today announced the completion of its Phase II Vibro-Tactile Stimulation (VTS) clinical study. This clinical program was designed to test TBS-2, a product the Company is developing to treat the Female Sexual Dysfunction condition of Anorgasmia. This recognized condition is defined as a women's inability to achieve or persistent difficulty in achieving orgasm even in conjunction with adequate sexual stimulation. The Company employed its proprietary intra-nasal bio-adhesive gel formulation of testosterone in the study using pre-loaded syringes as a dispenser.
In August, 2011, based upon positive preliminary data review, the Company advised the contract research organization running the study that patient enrolment would be considered complete on September 30, 2011 regardless of protocol mandated numbers. The Company will be presenting data from the VTS study to the Food and Drug Administration (FDA) at a meeting scheduled for November 2011. The Company expects that this meeting will lead to Trimel being in a position to commence its planned U.S. Phase II Ambulatory (AMB) clinical study in late 2011 or early 2012.
The recently completed VTS Study was designed to provide sufficient evidentiary building block data to allow for the implementation of the AMB clinical study. The study measured the effect of TBS-2 on the occurrence of orgasm, time to orgasm, the quality of orgasm, and placebo response rates for the anorgasmic patient population in order to assist in determining statistical power required in the AMB clinical study. The VTS study was also designed to identify appropriate patient inclusion and exclusion criteria for the AMB clinical study and the Biochemical markers and measureable patient physiological and emotional response rates to be studied in the upcoming AMB clinical study.
Since commencing the development of TBS-2 in 2010, the Company has in addition to the VTS study, successfully completed a Phase I/II clinical program where it dosed TBS-2 for the first time in patients, at a therapeutic level, while demonstrating that the dose is cleared and blood levels return to normal within the anticipated dosing period. This study further demonstrated positive downstream effects related to orgasm. Further, TB-2 demonstrated a physical response 30 minutes post dosing which is a clinical scientific breakthrough.