Posted by Art on October 17, 2002 at 07:43:57:
Wednesday October 16, 2002
Transition Therapeutics Commences Phase I Human Trial For I.N.T(TM)
TORONTO, ONTARIO--Transition Therapeutics Inc. ("Transition") (TSXV: TTH)
announced today that it has commenced a dose escalation Phase I human trial
in the United Kingdom for I.N.T.(TM).
I.N.T.(TM) is a short course of injections of two, well-defined human growth
factors that is being developed to stimulate the body to regenerate insulin-
producing islet cells.
The dose escalation Phase I human trial consists of 28 healthy volunteers and
each volunteer will receive one subcutaneous injection of one of the human
growth factors or a placebo.
Dr. Tony Cruz, Chairman and CEO of Transition, said that the commencement of
this trial is significant for both Transition as well as those with insulin-
dependent diabetes.
"This treatment has the potential to reduce and in some cases eliminate, the
need for insulin injections."
I.N.T.(TM) represents a promising development in the treatment of diabetes
because it consists of a simple, non-invasive regenerative therapy that
mimics the normal development of insulin-producing cells. I.N.T.(TM)
stimulates the body to regenerate insulin-producing cells that are damaged or
destroyed in those with insulin-dependent diabetes.
Preclinical studies have shown that mice injected with I.N.T.(TM) experienced
a significant regeneration of transplanted human islet cells. A second study
showed an increase in survival rate for diabetic mice. After the onset of
diabetes, the mice were treated with either I.N.T.(TM) or a placebo. After 28
days, all of the I.N.T.(TM)-treated mice were alive, whereas 60% of the
untreated mice died.
About Transition Therapeutics
Transition Therapeutics Inc. is a publicly listed biopharmaceutical company
developing innovative therapeutics focusing on the treatment of multiple
sclerosis, diabetes and restenosis. Transition offers a deep product
portfolio and a strong management team with expertise in product development.
Transition's management intends to continue to build shareholder value by
rapidly and cost effectively advancing products from discovery to the clinic
and licensing to corporate partners. Transition commenced a Phase I clinical
trial for its multiple sclerosis Interferon Enhancing Therapy in August 2002
and commenced a Phase I clinical trial for its diabetes Islet Neogenesis
Therapy in October 2002.
Notice to Readers: Certain information included in this press release is
forward-looking and is subject to important risks and uncertainties. The
results or events predicted in these statements may differ materially from
actual results or events. Factors which could cause results or events to
differ from current expectations include, among other things: the impact of
rapid technological and market change; the successful and timely completion
of clinical studies; the establishment of corporate alliances; new product
development; uncertainties related to the regulatory approval process; stock
market volatility; and the ability of Transition Therapeutics Inc. to recruit
and retain qualified employees. For additional information with respect to
certain of these and other factors, see the reports filed by Transition
Therapeutics Inc. with the Ontario Securities Commission. Transition
Therapeutics Inc. disclaims any intention or obligation to update or revise
any forward-looking statements, whether as a result of new information,
future events or otherwise.