TORONTO, ONTARIO--(Marketwire - Oct. 6, 2011) - Trimel Pharmaceuticals Corporation (TSX:TRL) 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.
Trimel's product candidate TBS-2 is a bioadhesive intranasal low-dose gel formulation of testosterone. TBS-2 is being developed to offer women with Anorgasmia, an on-demand treatment option improving their quality of life. TBS-2 is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the nasal applicator currently under development.
About Female Anorgasmia
Female Anorgasmia is an indication recognized by the Food and Drug Administration, or FDA, as a form of Female Sexual Dysfunction characterised by a woman's inability to achieve or persistent difficulty in achieving orgasm. This condition affects 1 in 5 pre and post menopausal women worldwide. Currently there are no approved treatments for Anorgasmia and therefore represents an unmet need for women suffering distress from this condition.
Trimel Pharmaceuticals Corporation (TSX:TRL). Developing Medications for Female Sexual Health and conditions related to Aging, and Well Being. Trimel is developing multiple product opportunities, including CompleoTRT, a bio-adhesive intranasal Testosterone gel for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.trimelpharmaceuticals.com.
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