Trimel Completes Patient Enrolment of CompleoTRT(TM) Phase III Trial
July 23, 2012 07:30 ET
Trimel Completes Patient Enrolment of CompleoTRT™ Phase III Trial
Efficacy Data Expected Q4 2012 Company preparing for pre-NDA meeting with FDA
TORONTO, ONTARIO--(Marketwire - July 23, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the "Company" or "Trimel") today announced the completion of enrolment and randomization of 304 patients in the Phase III clinical trial evaluating CompleoTRT™ in patients with male hypogonadism or more commonly referred to as "Low T". The unique delivery of CompleoTRT™ is designed to provide hypogonadal men with the therapeutic effect of restoring testosterone levels while doing so with a micro volume amount of drug in the form of a bioadhesive intranasal gel.
The pivotal Phase III clinical trial, which was initiated in October 2011, is a randomized study in which patients are administered CompleoTRT™ and evaluated for efficacy after 90 days of treatment using the pharmacokinetic endpoint established for Low T therapies. The Phase III study in its entirety represents the final stage of product development prior to the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for marketing approval in the United States.
Efficacy results from the Phase III clinical trial are expected to be available in the fourth quarter of 2012. As previously announced on May 29, 2012, the preliminary review of early data from the Phase III trial demonstrated that patients treated with CompleoTRT™ achieved an average serum testosterone level that exceeds the threshold required by the FDA to confirm the efficacy of a testosterone replacement product.
Bruce D. Brydon, Chairman and Chief Executive Officer, offered the following comments "Completion of patient enrolment and randomization of the CompleoTRT™ pivotal Phase III trial is an important milestone for Trimel. This achievement represents a key positive step toward completing our CompleoTRT™ clinical development program on time and on budget. The last of the patients in the treatment phase are expected to complete the study in October of this year, allowing for efficacy results to be available for all patients in the fourth quarter of 2012. This correlates well with our expected target to file the NDA at the end of 2012 if possible or the first quarter of 2013. We expect to hold a pre-NDA meeting with the FDA in November which should provide greater visibility on the filing date for CompleoTRT™."
Mr. Brydon further commented that "the fundamentals of our business are strong, both in terms of operational execution and managing our capital requirements. The recently completed financings, including a debt financing with GE Capital, a leading healthcare lender, further supports the underlying strength of our organization. We look forward to a long and mutually prosperous relationship with GE Capital."
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 bioadhesive intranasal gel.
CompleoTRT™'s intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (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". Since Trimel took over development in May 2009, CompleoTRT™ has been optimized to meet FDA regulatory requirements, including the development of a no-touch applicator device 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, having recorded over 10,000 drug exposures in the studies conducted 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 seriously affects 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 grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.
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 bioadhesive 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 or Kenneth Howling, Chief Financial Officer at (416) 679-0536 or via email at [ ir@trimelpharmaceuticals.com ].
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