(Source: PrimeNewswire)

TORONTO, Sept. 16, 2009 (GLOBE NEWSWIRE) -- Transition Therapeutics Inc. ("Transition" or the "Company") (TSX:TTH) (Nasdaq:TTHI), a product-focused biopharmaceutical company developing therapeutics for disease indications with large markets, today announced its financial results for the year ended June 30, 2009.
Selected Highlights
During fiscal 2009 and up to the date of this press release, the Company achieved the following significant milestones:
ELND005 (AZD-103) -- Alzheimer's Disease:
* On July 13, 2009, Elan Pharma International Limited ("Elan") and
Transition announced Phase I data showing ELND005 (AZD-103)
achieves desired concentrations in brain tissue and cerebrospinal
fluid when given orally;
* On April 23, 2009, Elan and Transition announced the receipt of a
key US patent for Alzheimer's Disease treatment with ELND005
(AZD-103);
* On October 20, 2008, Elan and Transition announced the
achievement of the patient enrollment target for a Phase II
clinical study of ELND005 (AZD-103) in patients with Alzheimer's
disease.
TT-223 -- Diabetes:
* On March 23, 2009, Transition announced the initiation of a Phase
Ib clinical study of TT-223 in combination with a glucagon-like
peptide-1 ("GLP-1") analogue in patients with type 2 diabetes;
* On February 5, 2009, Transition announced the completion of
patient enrolment for a Phase II clinical study of gastrin
analogue, TT-223, in patients with type 2 diabetes;
* On September 11, 2008, Transition dosed the first patient in a
Phase II clinical study of gastrin analogue, TT-223, in patients
with type 2 diabetes.
Drug Discovery Initiatives:
* On August 18, 2008, the Company announced the acquisition of
certain assets and the exclusive rights to selected drug
discovery projects from Forbes Medi-Tech (Research) Inc., a
wholly owned subsidiary of Forbes Medi-Tech Inc. ("Forbes").
Corporate Developments:
* On October 3, 2008, the Company received 23,272,633 freely
tradable common shares of Stem Cell Therapeutics Corp. ("Stem
Cell") pursuant to the terms of a share purchase agreement
entered into on October 4, 2004. In January 2009, the Company
disposed of these shares in open market transactions over the TSX
Venture Exchange which resulted in net proceeds of approximately
$1.4 million;
"Transition's goal has been to focus on products that have disease modifying characteristics for large disease indications. Today, after ten years of operations, Transition continues to pursue that vision. AD ("Alzheimer's Disease") drug candidate ELND005 (AZD-103) is in a Phase II trial with our collaboration partner, Elan. The lead diabetes drug candidate, TT-223, is in two clinical trials in collaboration with Eli Lilly. Also this year, we expect to commence clinical development of compounds TT-301 and TT-302. These oral small molecule compounds have potential applications in traumatic brain injury, multiple sclerosis and AD," said Dr. Tony Cruz, Chairman and CEO of Transition.
Pipeline Review
ELND005 (AZD-103) for Alzheimer's Disease
Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.
On December 21, 2007, Elan and Transition announced that the first patient had been dosed in a Phase II clinical study of ELND005 (AZD-103) in patients with Alzheimer's disease. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 340 patients with mild to moderate Alzheimer's disease. The study will evaluate both cognitive and functional endpoints, and each patient's participation is planned to last approximately 18 months. The study completed enrollment on October 20, 2008. The next steps in the development of ELND005 (AZD-103) will be to complete the current Phase II clinical study and with its partner Elan, set a plan for the late stage development of the product.
TT-223 for Diabetes
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 Phase IIa clinical trial data showed that a 4-week therapy with TT-223 in combination with EGF (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. Preclinical and clinical data suggests gastrin plays an important role in beta cell differentiation and function, capable of providing sustained glucose control in type 2 diabetes.
On September 11, 2008, Transition and its collaboration partner Lilly dosed the first patient in a Phase II trial evaluating TT-223 in type 2 diabetes patients receiving metformin and/or thiazolidinediones (TZDs). The study is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability and efficacy of daily TT-223 treatments for 12 weeks with a 6-month follow-up. Approximately 80 patients with type 2 diabetes were enrolled in the study and will receive a daily treatment of TT-223 in addition to their current regimen of oral glucose lowering agents (metformin and/or thiazolidinediones). The study completed enrollment on February 5, 2009.
On March 23, 2009, Transition and Lilly announced the initiation of a Phase Ib clinical study of TT-223 in combination with a GLP-1 analogue in patients with type 2 diabetes. The study is a randomized, double-blind, placebo-controlled study in approximately 140 patients to evaluate the safety, tolerability and efficacy of daily TT-223 treatments in combination with weekly administrations of GLP-1 analogue, for a combination treatment period of 4 weeks with a 5-month follow-up. This study is currently enrolling patients.
In the near term, Transition will focus on completion of the Phase II clinical study with TT-223 in type 2 diabetes patients and enrolment of the Phase Ib clinical trial with TT-223 in combination with a GLP-1 analogue in type 2 diabetes patients.
TT-301 / TT-302
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