TORONTO, Aug. 30 /CNW/ - Transition Therapeutics Inc. ("Transition")
(NASDAQ: TTHI, TSX: TTH) announced today the completion of Phase I clinical
studies with Alzheimer's disease drug candidate ELND-005/AZD-103. Transition
and its development partner Elan Corporation, plc. ("Elan") (NYSE: ELN) have
performed multiple Phase I studies evaluating the safety, tolerability and
pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers. Orally
administered ELND-005/AZD-103 may act through the unique mechanism of
preventing and reversing the fibrilization of beta-amyloid in preclinical
studies, presumed to be the toxic peptide in the brain of Alzheimer's
patients. ELND-005/AZD-103 is well positioned as a potential Alzheimer's
therapy as it is a small molecule that crosses the blood brain barrier and has
exhibited a favourable safety profile.
"We are very pleased with the Phase I data showing that the drug is safe
and well tolerated at all doses examined and achieves levels in the CSF and
brain that have been shown to be effective in breaking down beta-amyloid
fibrils in preclinical studies," said Dr. Tony Cruz, CEO of Transition.
"ELND-005/AZD-103 continues to show very favourable properties for the
treatment of Alzheimer's disease."
Approximately 110 subjects have been exposed to ELND-005/AZD-103 in
multiple Phase I studies, including single and multiple ascending dosing;
pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies.
ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens
examined. There were no severe or serious adverse events observed.
ELND-005/AZD-103 was also shown to be orally bioavailable, cross the
blood-brain barrier and achieve levels in the human brain and CSF that were
shown to be effective in animal models for Alzheimer's disease. The
pharmacokinetic data and safety data obtained in the Phase I studies will be
used to select the appropriate doses for the Phase II studies.
The next steps in the development of ELND-005/AZD-103 will be submission
of data supporting Phase II studies to the FDA. Transition and Elan anticipate
starting Phase II by the end of 2007 or early 2008.
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 regenerative
therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) 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
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. 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, adverse events that would require clinical trials
to be prematurely terminated, clinical results that indicate continuing
clinical and commercial pursuit of ELND-005/AZD-103 is not advisable, the fact
that the results from completed Phase I clinical trials are not always
indicative of those seen in future clinical trials, 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,
firstname.lastname@example.org; Mr. Elie Farah, CFO and VP Corporate
Development, Transition Therapeutics Inc., Phone: (416) 260-7770, x.203,
email@example.com; For further information on Elan, visit