TORONTO, Nov. 5 /CNW/ - Transition Therapeutics Inc. ("Transition" or the
"Company") (NASDAQ: TTHI, TSX: TTH) 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
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
- 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.
For further information:
For further information: on Transition, visit
www.transitiontherapeutics.com or contact: Dr. Tony Cruz, Chief Executive
Officer, Transition Therapeutics Inc, Phone: (416) 260-7770, x.223,
email@example.com; Mr. Elie Farah, CFO and VP Corporate
Development, Transition Therapeutics Inc., Phone: (416) 260-7770, x.203,