Trimel Pharmaceuticals Corporation Completes Treatment Phase of CompleoTRT(TM) Allergic Rhinitis Special Population Study
(firmenpresse) - TORONTO, ONTARIO -- (Marketwire) -- 04/27/12 -- Trimel Pharmaceuticals Corporation (TSX: TRL) (the "Company" or "Trimel") today announced the completion of the treatment phase of a special population study that will be included in the CompleoTRT™ New Drug Application ("NDA") for marketing authorization.
The Allergic Rhinitis / Drug-Drug interaction ("AR/DD") study involves the assessment of CompleoTRT™'s relative bioavailability, safety and tolerability when administered to patients suffering from seasonal allergic rhinitis. Completed AR/DD study results are expected by the end of the second quarter of 2012.
"The impending results of the AR/DD study represent an essential part of the CompleoTRT™ NDA," said Bruce D. Brydon, Chairman and Chief Executive Officer. "The Company looks forward to providing additional updates as we progress the CompleoTRT™ Phase III program to completion."
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 (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 effects from first-pass metabolism on the product, liver, or both.
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, 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 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 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 .
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 . 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
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Datum: 27.04.2012 - 05:30 Uhr
Sprache: Deutsch
News-ID 1107988
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