Transition Therapeutics Provides Update on Diabetes Program
TORONTO, November 05, 2007 /PRNewswire-FirstCall/ - Transition Therapeutics Inc. ("Transition" or the "Company") today announces an update on the clinical development and partnership activities for the Company's diabetes programs. Following good faith negotiations, Novo Nordisk A/S and Transition were not able to come to agreement for an exclusive license to the Company's diabetes programs. Accordingly, Transition has sent notice to Novo Nordisk A/S terminating the agreement between the companies, which will return to Transition all rights held by Novo Nordisk A/S, relating to E1-I.N.T. Transition will continue on-going discussions with other interested parties to partner the diabetes programs. In the interim, the Company is fully committed to support and advance the clinical development of the diabetes programs, leveraging its expertise in disease-modifying therapies for diabetes, world-class scientific advisory board and solid financial position.
Preclinical data in diabetes animal models demonstrate the efficacy of gastrin analogues alone, or in combination with GLP-1 analogues or epidermal growth factor analogues. In humans, Transition's recent Phase IIa clinical trial data showed that 4-weeks of E1-I.N.T. therapy (combination of gastrin analogue and epidermal growth factor analogue) in type 2 diabetes patients resulted in sustained reductions in blood glucose control parameters, including haemoglobinA1C, for 6 months post-treatment. These data suggest that gastrin plays an important role in beta cell differentiation and function, capable of providing sustained glucose control in type 2 diabetes. Transition has commenced the studies to advance its lead gastrin analogue, TT-223, formerly known as "G1", into Phase II clinical trials in type 2 diabetes patients.
To support the Phase II clinical development program for TT-223, Transition is currently performing Phase I studies to expand the dose ranges for TT-223. The first study, a single ascending dose study of TT-223 in healthy volunteers has completed dosing. The second study, a multiple ascending dose study of TT-223, is expected to begin later this year.
Transition expects to initiate the following Phase II clinical studies evaluating TT-223 in type 2 diabetes:
- A dose-range finding Phase II study evaluating TT-223 in type 2 diabetes patients receiving metformin with or without thiazolidinediones (TZDs) to commence in the first half of next year. - An additional Phase II study with TT-223 in type 2 patients receiving either GLP-1 analogue therapy or insulin therapy is anticipated to follow. - The next steps in the development of TT-223 in combination with Transition's epidermal growth factor analogue, formerly known as "E1-I.N.T.", will be evaluated following the review of data from the above proposed Phase II studies.
Transition will continue to work closely with the Juvenile Diabetes Research Foundation on development of TT-223 in combination with GLP-1 analogues for the treatment of type 1 diabetes. The clinical studies in type 1 diabetes patients will be disclosed at a later date.
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND-005/AZD-103 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates developed using its proprietary drug discovery engine. Transition's shares are listed on the NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For additional information about the Company, please visit www.transitiontherapeutics.com.
Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release and may be superseded by more recent information we have disclosed in later press releases, filings with the OSC, SEC or otherwise. Except for historical information, this press release may contain forward-looking statements, relating to expectations, plans or prospects for Transition, including conducting clinical trials and potential efficacy of our products. These statements are based upon the current expectations and beliefs of Transition's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include factors beyond Transition's control and the risk factors and other cautionary statements discussed in Transition's quarterly and annual filings with the Canadian commissions.
CONTACT: on Transition, visit www.transitiontherapeutics.com or contact:Dr. Tony Cruz, Chief Executive Officer, Transition Therapeutics Inc, Phone:(416) 260-7770, x.223, ; Mr. Elie Farah,CFO and VP Corporate Development, Transition Therapeutics Inc., Phone:(416) 260-7770, x.203, email@example.com firstname.lastname@example.org
Ticker Symbol: (Toronto:TTH.),(NASDAQ-NMS:TTHI)
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Posted: November 2007