ThromboGenics Ltd. Announces the Initiation of Phase II Trial of Microplasmin.

DUBLIN, Ireland -- Investigating New Drug for Treatment of Disorders of the "Back of the Eye"

ThromboGenics Ltd. today announced the start of a Phase II trial evaluating recombinant microplasmin in patients with vitreoretinal disorders, also referred to as diseases of the "back of the eye". Microplasmin is a truncated form of the human protein plasmin; ThromboGenics has developed on a proprietary basis the first stabilized and readily manufactured form of this unique protein.

Microplasmin has the potential to simplify a surgical procedure called vitrectomy, which is used to treat visual conditions. Vitrectomy involves separation of the vitreous (the gel-like substance in the center of the eye) from the retina, inducing a posterior vitreous detachment (PVD), a technique considered beneficial in patients with numerous retinal conditions, including diabetic retinopathy and macular edema.

The breakthrough procedure using plasmin for induction of PVD was invented by Drs. Michael Trese and George Williams, the founders of NuVue Technologies, which owns exclusive rights for the use of plasmin in ophthalmic applications. A formal licensing agreement between ThromboGenics and NuVue brings into a single portfolio all intellectual property relating to plasmin-based compounds for treatment of eye diseases.

This Phase II trial, in which the first patient was treated in December 2004, will enroll up to 50 patients at 3 centers in the Netherlands and Germany. The investigators for the study are Professors Marc de Smet (Amsterdam), Arnd Gandorfer and Anselm Kampik (Munich), and Eric Feron (Rotterdam), Patients with vitreoretinal disease for whom vitrectomy is indicated will be enrolled. The trial is primarily designed to provide valuable safety information on the use of microplasmin in this setting, on which dose selection for future clinical trials can be based. Subject to interim results from this trial, ThromboGenics plans to submit an Investigational New Drug (IND) application to FDA to allow for initiation of a U.S. clinical trial with microplasmin in 2005.

Given the difficulties inherent in inducing a PVD by surgical vitrectomy, a drug given prior to vitrectomy that could facilitate this process may lead to more rapid surgery with fewer complications. It could also lead to treatment in an office-based setting for conditions that otherwise would have required surgery. More than 500,000 vitrectomies are performed annually worldwide (more than 200,000 in the U.S.), most commonly for complications related to diabetic retinopathy. Diabetic retinopathy affects more than 5.4 million Americans, and is the leading cause of blindness in the working-age population. The surgery is also performed to treat macular edema, which affects 1.6 million people worldwide, including 650,000 Americans.

ThromboGenics has performed extensive pre-clinical work with microplasmin, including toxicology and pharmacology studies, in the laboratories of several prominent researchers in the vitreoretinal field. A Phase I trial for systemic administration of microplasmin has also been successfully completed.

"Advancement of this program into Phase II is an exciting milestone for our company," stated Desire Collen, M.D., Ph.D., Chairman and CEO of ThromboGenics, adding "The potential of microplasmin to fill a significant unmet need, both as an adjunct to vitrectomy and as an agent that could allow office-based treatment, continues to generate substantial excitement in the ophthalmic community."

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ThromboGenics Ltd. is a privately held company founded in Dublin, Ireland, focused on biotherapeutics for the prevention and treatment of heart attack, stroke, peripheral artery disease, eye disease, and cancer.

ThromboGenics has exclusive rights to certain therapeutics developed at University of Leuven (Belgium). ThromboGenics' partners include BioInvent International (Sweden), Chemicon International AB (U.S.), Geymonat S.p.A. (Italy) and NuVue Technologies (U.S.). The Company has research labs in Belgium, via its subsidiary Thromb-X, N.V., and management team located in Ireland, Belgium and the U.S.

ThromboGenics has two programs in clinical development: 1) microplasmin, both as a treatment for retinal disorders and as a neuroprotective thrombolytic agent for stroke and peripheral arterial occlusive disease, and 2) staphylokinase as a thrombolytic agent for acute myocardial infarction. The Company also has five other programs in pre-clinical development with proof-of-principle demonstrated. More information can be found at www.thrombogenics.com.