LEUVEN, Belgium, December 4 /PRNewswire/ --
- Microplasmin Shows Clear Promise in Back of the Eye Disease, With Treated Patients Achieving Macular Hole Closure and Traction Release Without Need for Vitrectomy
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular and eye diseases, will today present results from its Phase IIa MIVI IIT trial at the American Society of Retina Specialists (ASRS) 25th Annual Meeting in Indian Wells, California. The trial, which delivered positive clinical results in a number of the treated patients, was designed to evaluate both the safety and efficacy of microplasmin injection for the treatment of vitreomacular traction, an important cause of back of the eye disease. The results of the study will be presented by Professor Peter Stalmans, University Hospitals, Leuven, Belgium.
Vitreomacular traction is a condition where the vitreous (the central fluid part of the eye) has an abnormally strong adhesion to the surface of the macula (the part of the retina responsible for detailed vision). Due to this, the macula may become distorted creating poor or deficient vision. Vitreomacular traction can also lead to sight threatening conditions such as macular holes or macular edema.
In current practice, these conditions are treated by a highly skilled surgical procedure called vitrectomy. The procedure uses suction to remove the vitreous from the eye to induce posterior vitreous detachment or PVD, thereby alleviating the vitreomacular traction. The potential use of microplasmin to treat vitreomacular traction could therefore provide a more convenient, much less invasive approach, to both patients and physicians, for the treatment of important back of the eye diseases such as macular holes, diabetic macular edema, diabetic retinopathy in general, and even in age related macular degeneration (AMD), which are caused or exacerbated by the vitreous adhering to the retina abnormally.
The Phase IIa MIVI-IIT trial reported today was a sham injection controlled study in which patients were assigned to receive either 75ug or 125ug of microplasmin. A total of 30 patients across Europe were recruited to the study, of which 24 received microplasmin therapy while 6 received the sham injection. The trial showed clear benefits from therapy with 9 of the 24 microplasmin treated patients seeing resolution of their vitreomacular traction (including macular hole closure in 2 of the 4 macular hole cases) without the need for vitrectomy. In contrast, none of the 6 sham injected patients had resolution of their vitreomacular traction (including two patients with macular hole). The trial also showed that microplasmin therapy was safe and well tolerated. Given the excellent safety of microplasmin in the trial to-date, it has been decided to recruit a further 15 patients (12 treated and 3 sham) to evaluate a higher 175ug dose of the product to see if it will produce even better clinical outcomes.
Professor Peter Stalmans, the study's principal investigator, commented: "The results from the study that I will present at the ASRS meeting today clearly indicate the potential for microplasmin to become a more convenient, less invasive, hence more patient friendly treatment for vitreomacular traction. The fact that we have been able to clearly show that microplasmin can achieve clinically important outcomes such as traction release and macular hole closure without surgery augurs well for the future development of this novel treatment."
Prof. Desire Collen, CEO of ThromboGenics, commenting on today's results said: "The results of the microplasmin trial that we have announced today clearly show the drug's potential to treat a range of back of the eye diseases. The clinical benefits that we have seen in this study in conjunction with its excellent safety profile provide us with sound reasons for pushing ahead with the further clinical development of microplasmin."
About Vitreomacular Traction
Numerous conditions are associated with vitreomacular traction which may lead to decreased vision and/or complications. These include macular hole, macular edema (ME) associated with vitreomacular traction, and vitreomacular traction syndrome (VTMS). The only available treatment for these conditions is surgical vitrectomy, in order to induce a posterior vitreous detachment (PVD) and thereby alleviate the vitreomacular traction. Therefore, a pharmacological agent that could relieve vitreomacular traction nonsurgically would be a dramatic advance for the treatment of these conditions, preventing the need for surgery and its associated cost, inconvenience and risk of complications. Macular hole prevalence is approximately 0.14% of general population, leading to estimates of approximately 400,000 cases in the US and of up to 1 million in the industrialized world.
Other potential nonsurgical applications for microplasmin include treatment of macular edema and diabetic retinopathy. Diabetic retinopathy is the leading cause of blindness among working-age adults while diabetic macular edema (DME) is the leading cause of decreased vision in patients with diabetic retinopathy. Around 750,000 patients suffer from DME in the United States alone.
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular and eye diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases, including acute stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical development in 2008, and TB-403 (Anti-PlGF), which is expected to proceed to Phase I clinical trials by the end of 2007. ThromboGenics has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.
SOURCE ThromboGenics NV