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Capefearon Mar 21, 2000 12:57pm
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News
NewsIsotechnika Inc. Announces the IND Filing of its New Immunosuppressive Drug
ISAtx247 Application to The Food and Drug Administration (FDA) of the United States of
America
EDMONTON, March 21 /CNW/ - Dr. Randall Yatscoff, President of Isotechnika
Inc. is pleased to announce the IND filing of Isotechnika's new
immunosuppressive drug ISAtx247 to The Food and Drug Administration to obtain
approval to commence human clinical trials in the United States. A parallel
filing with the Canadian Health Protection Branch received approval earlier
this month.
``This represents a significant milestone achievement for Isotechnika as
it is the first drug in our pipeline to complete pre-clinical testing prior to
entering human clinical trials. Parallel Phase 1 trials in humans will be
performed in Canada and the United States. The Canadian trials will commence
at the end of April. With the filing in the United States it is anticipated
that trials will commence in that country later this spring. The completion of
pre-clinical trials and the filing of the drug for approval for human trials
in two countries in a short period of time speaks to the hard work, dedication
and diligence of our core group of highly trained scientists'' said Dr.
Randall Yatscoff.
ISAtx247 is a novel immunosuppressive drug, which is designed to be used
for prevention of organ rejection after transplantation and for treatment of
autoimmune diseases such as arthritis and psoriasis to name a few. Based on
the completed pre-clinical studies, ISAtx247 demonstrates superior efficacy
and reduced toxicity when compared with presently used medications such as
Cyclosporine for prevention of organ rejection after transplantation and for
treatment of autoimmune diseases. Current annual worldwide sales of
Cyclosporine are in excess of $2 billion USD. ``Subsequent to the completion
of Phase 1 trials it is our intention to develop the drug for a number of
transplant and autoimmune indications. The significant in-house expertise in
immunosuppressive drug research under the direction of Dr. Yatscoff who has
greater than 20 years experience in this area should ensure rapid progression
of the drug through the human clinical trial phases'' said Dr. Robert Foster,
Chairman and CEO of the Corporation.
Isotechnika is a life sciences company headquartered in Edmonton, Alberta
developing novel drugs and diagnostic products. The development costs of
Isotechnika's lead drug is being supported in part, by sales of the company's
breath-based point-of-care diagnostic kits. These kits aid in the diagnosis
of ulcers, diabetes and insulin resistance, fat malabsorption, small bowel
bacterial overgrowth, and lactose intolerance. Isotechnika's diagnostic kits
are designed to be used with a point-of-care instrument developed by the
company.