ThromboGenics' Microplasmin Phase III Program Progressing According t...(i-centre randomized placebocontrolled do...),Health

Date:6/24/2009

i-centre, randomized, placebo controlled, double-masked trials which will evaluate 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol a total of approximately 320 patients each across approximately 40 centres in the United States (TG-MV-006) and 40 centres in Europe and North America (TG-MV-007). The safety review was the final of two safety reviews, and had been scheduled to take place after 50% of patients had been enrolled in one of the studies.

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion within one month. Additional measures of efficacy and safety will also be assessed at various intervals over six months in both studies. It is estimated that these two studies will be completed by the end of 2010.

Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on the announcement said, "We are very pleased that the Phase III program for microplasmin is progressing well and that enrolment is on track. We remain confident that microplasmin could potentially make a significant difference to the treatment of back of the eye disease and we very much look forward to reporting the results from these trials."

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and development of innovative biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. The Company's lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting
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SOURCE ThromboGenics NV Copyright©2009 PR Newswire. All rights reserved

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