TORONTO, ONTARIO, Mar 22, 2012 (MARKETWIRE via COMTEX) -- Trimel Pharmaceuticals Corporation (“Trimel” or “the Company”) today announced positive results from the completion of a Pharmacokinetic (“PK”) study investigating Tefina(TM), a product for which the Company has already completed a Phase II clinical trial and continues to develop for the treatment of anorgasmia, a prevalent form of female sexual dysfunction.
The Tefina(TM) PK study was designed to measure the levels of testosterone in the blood stream at prescribed time points post-administration, providing supportive evidence (as recommended by the United States Food and Drug Administration (“FDA”)) related to the safety of the PK profile of Tefina(TM) from both single and multiple dose exposures in a cohort of healthy women.
Following the completion of the study where single and multiple dose administrations were given across three dosing levels, average levels of testosterone in the blood stream over a 24 hour period remained within the normal range. All women in the study also demonstrated a return to their starting testosterone blood levels within 24 hours after the last administration of Tefina(TM). This study completes another step in the path towards filing a new drug application for Tefina(TM), an expected first-in-class treatment under investigation for an unmet need in female sexual health.
“This PK study marks another important milestone in the Company’s strong working relationship with the FDA,” commented Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel. “Demonstrating that a woman’s level of testosterone in the blood stream stays within the normal range after multiple doses of Tefina(TM), and that Tefina(TM) clears from a women’s blood stream within 24 hours after treatment, are important pieces of evidence in demonstrating the safety of Trimel’s novel ‘use as required’ treatment approach.”
During the first quarter of 2012, in addition to the aforementioned Tefina(TM) PK study, the Company announced favourable results from a Vibrotactile Stimulation (“VTS”) study involving Tefina(TM). The VTS study measured the occurrence of, time to reach, and the quality of the orgasm, as compared to placebo. On the key metric of achieving orgasm, the VTS study results indicated that the separation between placebo and active drug demonstrated a positive finding for Tefina(TM). The VTS study further investigated improvements in the key measures of sensuality, sexual arousal and genital sensation. For all the metrics listed, Tefina(TM) again demonstrated a meaningful separation from placebo.
The Company expects to move expeditiously to implement a second Phase II study of anorgasmia involving Tefina(TM). This upcoming multinational ambulatory clinical study will be one of the largest to ever explore a “use as required” treatment for women experiencing any form of anorgasmia.
About Tefina(TM)
Trimel’s product candidate Tefina(TM) is a bioadhesive ‘no touch’ intranasal low-dose gel formulation of testosterone. Tefina(TM) is being developed to offer women with anorgasmia, a “use as required” treatment option. Tefina(TM) 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 multi-dose dispenser.
About Female Anorgasmia
Anorgasmia is defined as the persistent or recurrent delay in, or absence of, orgasm following normal sexual excitement phase that causes marked personal distress or interpersonal difficulties. The etiology of anorgasmia is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary). 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.
About Trimel
Trimel Pharmaceuticals Corporation is a unique specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction, and various respiratory disorders. Trimel is developing multiple product opportunities, including CompleoTRT(TM), a bio-adhesive intranasal Testosterone gel currently in Phase III clinical testing at more than 30 sites across America. CompleoTRT(TM) is for the treatment of male hypogonadism, a condition commonly referred to as “Low T”. For more information, please visit www.trimelpharmaceuticals.com .
Notice regarding forward-looking statements:
Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, are assumptions regarding our future operational results. These assumptions, although considered reasonable by the Company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the Company is subject to a number of risks and uncertainties, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our final prospectus which is available at www.sedar.com . Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0771
www.trimelpharmaceuticals.com
