May 17, 2012 07:30 ET
Trimel's Tefina™ 240-Patient Clinical Trial Opens Enrolment
TORONTO, ONTARIO--(Marketwire - May 17, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) (the "Company" or "Trimel") today announced the initiation of patient enrolment into one of the largest clinical studies to ever explore a "use-as-required" treatment for women experiencing anorgasmia. Anorgasmia is defined as the persistent or recurrent delay in, or absence of, orgasm following a normal sexual excitement phase which can result in marked personal distress or interpersonal difficulties. Anorgasmia affects 1 in 5 women worldwide. Currently there are no approved treatments for anorgasmia and therefore this condition represents a significant unmet need for women suffering distress from this condition.
The Company intends to enroll 240 patients in this Phase II study being initiated in the United States, with additional sites in Canada and Australia expected to join the study in the third quarter of 2012. The Tefina™ Phase II study design will involve pre-menopausal women experiencing anorgasmia and will be conducted as an ambulatory trial. As part of this double-blinded placebo-controlled study, patients will receive Tefina™ or placebo at home instead of in a hospital setting. The primary efficacy endpoint of the ambulatory trial will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels.
The principal investigator for this study is Dr. Sheryl Kingsberg. Dr. Kingsberg is the Chief of Behavioral Medicine at University Hospitals Case Medical Center and Professor in Reproductive Biology and Psychiatry at Case Western Reserve University in Cleveland, Ohio. Dr. Kingsberg's primary research interests are in treatments for female sexual disorders and the psychological aspects of infertility and menopause. She is an active member in a number of national and international scientific organizations and is the immediate past president of the International Society for the Study of Women's Sexual Health.
Joining Dr. Kingsberg as the lead Australian investigator is Dr. Susan Davis, an endocrinologist and Professor of Women's Health in the School of Public Health and Preventive Medicine at Monash University in Victoria, Australia. Dr. Davis has published extensively in the field of women's health with specific focus on sex steroid depletion and sex steroid therapy in women.
Dr. Kingsberg offered the following comment: "Tefina™ is an innovative treatment approach for the many women suffering from female orgasmic disorder, or anorgasmia. I am pleased to be working with Trimel in order to advance the clinical development of Tefina™."
"The clinical relevance and the potential opportunity presented by Tefina™ in female sexual health is directly reflected in the credentials of the investigators attaching their names to the clinical program for this product." said Bruce D. Brydon, Chairman and Chief Executive Officer. "We are excited to be entering this second Phase II study which builds upon the results of the VTS study released earlier this year and should help shape the design of a potential Phase III Tefina™ program".
Trimel's product candidate Tefina™ is a bioadhesive 'no touch' intranasal low-dose gel formulation of testosterone. Tefina™ is being developed to offer women with female orgasmic disorder, a "use as required" treatment option. Tefina™ 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 Orgasmic Disorder ("Anorgasmia")
Female Orgasmic Disorder (FOD) 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 FOD 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 FOD 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 currently in Phase III clinical testing in the United States. CompleoTRT™ is under investigation for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.trimelpharmaceuticals.com.
For further information regarding Trimel Pharmaceuticals Corporation, please contact either Bruce Brydon, Chairman of the Board and Chief Executive Officer at (416) 679-0711 begin_of_the_skype_highlighting (416) 679-0711 end_of_the_skype_highlighting or Kenneth Howling, Chief Financial Officer at (416) 679-0536 begin_of_the_skype_highlighting (416) 679-0536 end_of_the_skype_highlighting or via email at email@example.com.
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