Health & Fitness
Health and Fitness
Health and Fitness
Tue, November 1, 2011
Mon, October 31, 2011
Trimel Initiates Dosing in Phase III Trial of CompleoTRT in Male Hypogonadal Patients
October 31, 2011 08:00 ET
Trimel Initiates Dosing in Phase III Trial of CompleoTRT in Male Hypogonadal Patients
TORONTO, ONTARIO--(Marketwire - Oct. 31, 2011) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the Company" or "Trimel") today announced that it has dosed the first patient in the pivotal Phase III trial of its first-in-class bio-adhesive intranasal testosterone gel product CompleoTRT. The Phase III trial will be conducted with male patients suffering from hypogonadism, a chronic condition commonly referred to as Low Testosterone or "Low T" that is estimated to affect nearly 13 million men in the United States alone.
The Company intends to treat approximately 280 patients in this Phase III which is being conducted in the United States at 30 investigator sites. Dr. Lorne Tyrell MD PhD FRCP is the Principal Investigator. Dr. Tyrell is a Professor of Medicine, Biochemistry and Medical Microbiology and Immunology and the former Dean of the Faculty of Medicine and Dentistry at the University of Alberta. Dr. Tyrell's exceptional contribution to medical research has been recognized by his peers through the receipt of numerous awards, including the Prix Galien Canada Medal for Research.
"We are very pleased that patient enrollment in the CompleoTRT Phase III trial is underway and has met our original timelines" said Bruce Brydon, Chairman of the Board and Chief Executive Officer, Trimel Pharmaceuticals Corporation. "Trimel remains committed to developing safe and effective treatments for men suffering from low testosterone looking for better options than what is currently available."
The Phase III trial protocol requires patients to be administered drug for 90 days in a randomized, pharmacokinetic endpoint program, evaluating the efficacy and safety of CompleoTRT in the treatment of male hypogonadism.
Trimel's recently completed Phase II trial which was conducted with 30 patients treated with CompleoTRT exhibited results which exceeded the FDA guidance for approval of a product in this therapeutic category. The Phase III trial will utilize the same primary pharmacokinetic endpoint as achieved in the successful Phase II study.
About CompleoTRT
CompleoTRT is designed to represent a significant advancement in the treatment of male hypogonadism, or low testosterone – commonly known as "Low T". CompleoTRT's unique delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bio-adhesive intranasal gel.
CompleoTRT's intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (primary or secondary transference) of testosterone to spouses or other family members, thus offering unique patient benefits and improved safety as compared to other currently marketed products indicated to treat "Low T". Moreover, CompleoTRT is designed to avoid the negative impact of first-pass metabolism on the product, liver, or both.
Since Trimel took over development of the product in the second half of 2009, CompleoTRT has been optimized to meet FDA regulatory requirements, including the development of a product dispenser that is designed to ensure that CompleoTRT is dosed accurately and discretely. Trimel's research program to date has demonstrated that CompleoTRT is safe and effective, with over 3500 drug exposures studied thus far in the United States.
About Hypogonadism ("Low T")
Subject to FDA approval, Trimel's lead product candidate, CompleoTRT, would be indicated for the treatment of male hypogonadism or low testosterone – commonly known as "Low T". Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone levels that can be either acquired or inherited, and can seriously affect the quality of life for those affected with the syndrome. Low testosterone is estimated to affect 13 million men in the United States, of which an estimated 90% go untreated. According to IMS Health, sales of marketed treatments for low testosterone in North America exceeded $1 billion annually in 2010.
About Trimel
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 ].
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.
