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Collaboration on Development of Plasmin-Based Drugs for Visual Disorders.





March 10, 2004.

Press Release.
Source: ThromboGenics Ltd.




ThromboGenics Ltd. has entered into a collaborative agreement with NuVue Technologies Inc., leaders in the research and application of vitreoretinal surgery techniques, for development of plasmin-based products -- recombinant microplasmin and autologous plasmin -- as candidates to treat serious visual disorders. Use of plasmin products have been shown to be effective for the induction of posterior vitreous detachment (PVD), a technique which is considered beneficial in patients with numerous retinal conditions, including diabetic retinopathy and macular edema.


The collaboration brings into a single portfolio all relevant intellectual property relating to the manufacture and use of plasmin-based compounds for treatment of eye diseases. NuVue's founders invented the breakthrough procedure using autologous plasmin for induction of PVD, and the company owns exclusive rights for its ophthalmic use. The commercial application of autologous plasmin is, however, somewhat restricted because it is a protein of limited stability that needs to be isolated from individual patients' blood. To facilitate application, ThromboGenics developed the first stabilized and readily manufactured form of this unique protein, called recombinant microplasmin. ThromboGenics owns the exclusive rights to the production and therapeutic use of recombinant microplasmin, and today's agreement gives the company exclusive license to NuVue's technology.


More than 500,000 surgical vitrectomies are performed annually worldwide (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.


"While autologous plasmin is highly effective for select treatment situations, the stable, recombinant form is more commercially viable, and a logical next step," explains Dr. Michael Trese, co-founder of NuVue. "It will allow access to as wide a patient population as possible."


"Plasmin-related products may also allow certain treatments, such as those for diabetic retinopathy and macular hole, to be performed without a surgical procedure," added Dr. George Williams, co-founder of NuVue. "Additional indications for these products, such as vitreous hemorrhage, subretinal hemorrhage, ocular inflammation, and retinal vein occlusion, may allow for further growth in the use of this agent in an ophthalmic setting."


Drs. Michael Trese and George Williams, are both practicing vitreoretinal surgeons associated with William Beaumont Hospital in Royal Oak, MI.


"By joining together with NuVue, we will accelerate the development of this therapy, which has shown promising pre-clinical results in a variety of animal models," said Professor Desire Collen, Chairman and CEO of ThromboGenics. "We expect to begin human trials of microplasmin for ophthalmic use as early as this summer. Our long-range goal is to attract a third party for clinical development, ultimately leading to a commercial drug."


Research Shows Potential to Ease, Even Replace, Difficult Surgical Procedure


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. Drs. Marc de Smet (University of Amsterdam), Jerry Sebag (VMR Institute in California), Anselm Kampik and Arnd Gandorfer (University of Munich) have all conducted studies evaluating the safety and efficacy of microplasmin for inducing PVD. Dr. de Smet's work has been presented at several ophthalmic conferences (including ARVO and Schepens in 2003), and Dr. Gandorfer published his findings in Investigative Ophthalmology & Visual Science in February 2004. A Phase I trial for systemic administration of microplasmin has been successfully completed by ThromboGenics.


In current clinical practice, PVD is induced via surgical vitrectomy, whereby the vitreous (the gel-like substance in the center of the eye) is intentionally removed from the retina, for treatment of a variety of retinal conditions. Given the difficulties inherent in detaching the vitreous by surgical vitrectomy, a drug given prior to surgical vitrectomy that could facilitate the induction of PVD 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.


ThromboGenics Ltd. is a privately held company headquartered in Dublin, Ireland, focused on discovery and development of biotherapeutics for cardiovascular diseases. ThromboGenics has exclusive rights to certain therapeutics developed at University of Leuven (Belgium). The Company has research labs in Belgium, 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 2) staphylokinase as a thrombolytic agent for acute myocardial infarction. ThromboGenics also has five other programs in pre-clinical development with proof-of-principle demonstrated. More information is available at www.thrombogenics.com.


NuVue Technologies is a privately held company headquartered in Keene, NH. NuVue was founded by Drs. Michael Trese and George Williams, practicing vitreoretinal surgeons who developed and patented the first methods for isolating plasmin and using it to effect the removal of vitreous from the retinal surface. Their techniques have been used on hundreds of patients, including premature infants and the most complex pediatric cases. Drs. Trese and Williams both have published extensively in the field, speak often about the importance of pharmacologic vitreolysis, and are highly regarded in the ophthalmic community. NuVue is commercializing a proprietary device for the isolation and application of autologous plasmin for vitreoretinal use. Clinical trials in this area are ongoing.




End of article.






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