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ThromboGenics N.V.: Business Update
Date:11/6/2008

pected to begin in Q1 2009. It is anticipated that this Phase III development program will use the 125 (micro)g dose of microplasmin.

The decision to move into this Phase III program was in part based on the positive results from the Phase IIb MIVI III trial announced in late June. The MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial showed that the most effective dose of microplasmin studied (125 (micro)g) was able to resolve the underlying disease in approximately 30% of patients without the need for a vitrectomy (surgical intervention). The encouraging results from this study were presented by Dr. George Williams (Beaumont Hospital, Michigan, USA) on June 28 at the World Ophthalmology Congress in Hong Kong.

The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial that evaluated three doses of microplasmin (25, 75 and 125 (micro)g) versus placebo in 125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the United States. The trial was designed to assess the safety and efficacy of microplasmin intravitreal injection given 7 days prior to the patient's planned vitrectomy.

The study showed that microplasmin was well tolerated. The trial also showed a clear dose response curve with the highest dose (125 (micro)g) of microplasmin delivering the best results. In this group, 10 of the 32 patients receiving this dose of microplasmin had resolution of their underlying disease, and therefore did not need a vitrectomy for the indication for which they were being treated. This compares very favorably with the placebo group, where only 1 patient out of 31 achieved the same positive outcome. In addition, use of microplasmin was associated with a reduced amount and duration of suction needed to achieve a PVD in patients who progressed to surgical intervention, compared to placebo.

The visual acuity of all patients recruited into the study was also measured at
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SOURCE ThromboGenics NV
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