Genzyme Transgenics Corp has begun Phase I clinical testing (in healthy human volunteers) of its transgenic form of antithrombin III (ATIII), a plasma protein that helps prevent harmful blood clotting in many serious medical conditions. This first study will take place in the UK, and is expected to be completed in about one month.
GTC has already completed successful preclinical safety and toxicity studies in animals and intends to file an Investigational New Drug application this fall for a second trial in the USA later this year. The company plans to initiate a Phase I/II clinical study which will be aimed at a reduction in bleeding and in the amount of donor blood needed by patients undergoing coronary bypass surgery.
Plasma-derived ATIII is now on the market for a number of acquired ATIII deficiency indications in Europe and Japan. The animal milk-derived form is being developed to expand the available indications and ultimately it may replace the plasma version. GTC believes new uses may increase the potential market for the product well beyond the current $200 million turnover worldwide.
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