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Isotechnika receives approvals from FDA, Health Canada for Phase II trials of renal transplant drug.

Isotechnika, Inc., Edmonton, Alberta, Canada has received approvals from both the FDA and Health Canada to begin Phase II clinical trials in human patients to evaluate its new immunosuppressive drug ISATX247 in renal transplantation. The trials will begin at 10 sites throughout the US in June.

The company says ISATX247 is a novel immunosuppressive drug designed to prevent organ rejection after kidney transplantation and to treat autoimmune diseases such as arthritis and psoriasis. Isotechnika reports that in completed pre-clinical and Phase I studies in humans, ISATX247 has demonstrated more potent and less toxicity when compared with currently used medications such as cyclosporine.

The company says 22 separate studies were completed to meet all the filing requirements for Phase II trials. ISATX247 will be administered to transplant patients to confirmed earlier findings of its increased potency and reduced toxicity compared to cyclosporine.

Contact: www.isotechnika.com
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Comment:Isotechnika receives approvals from FDA, Health Canada for Phase II trials of renal transplant drug.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1CANA
Date:May 26, 2001
Words:145
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