LEUVEN, Belgium, May 23 /PRNewswire-FirstCall/ --
- Results Confirm the Beneficial effects of Microplasmin in Patients With Vitreomacular Traction Without Need for Vitrectomy Throughout the 6 Month Follow-Up Period
ThromboGenics NV , a biotechnology company focused on vascular and eye diseases, today presented the six month follow up results from its Phase IIa MIVI IIT trial at the Euretina Congress in Vienna, Austria. 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 were presented by Professor Peter Stalmans, University Hospitals, Leuven, Belgium.
Professor Peter Stalmans had previously presented positive one month follow-up results in the first 30 patients (6 patients received a sham injection and 24 patients received microplasmin injection) at the American Society of Retinal Specialists Meeting on Dec. 4, 2007.
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.
The Phase IIa MIVI-IIT trial reported today, was a sham injection controlled study in which patients were assigned to receive either 75 (micro)g or 125 (micro)g of microplasmin. Analysis of the full follow-up of these patients showed benefits from therapy with 10 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 most of these patients this success was achieved shortly after microplasmin treatment. In contrast, only one of the 6 sham injected patients had non-surgical resolution of their vitreomacular traction and this took the full 6 months to achieve.
Importantly, full 6 month follow-up results demonstrate that the success in terms of resolution of the vitreomacular traction has translated into clinical benefit for these patients. None of the sham treated patients were able to achieve this very important clinical end point. The full 6 month follow-up results of these patients also showed that microplasmin therapy continued to be well tolerated.
Given the excellent safety of microplasmin in the trial to-date, the size of this trial has been doubled by the addition of two further cohorts of 15 patients. The 3rd cohort of patients receive a higher 175 (micro)g dose of microplasmin while the 4th cohort receive repeated monthly injections of 125 (micro)g of microplasmin.
All 60 patients have now been enrolled into the trial. The results from these 2 additional cohorts of patients will be presented at major ophthalmological meetings during the course of the second half of 2008.
Professor Peter Stalmans, the study’s principal investigator, commented: “The results that I presented at the Euretina meeting today make me even more confident that microplasmin has the potential to become the treatment of choice for vitreomacular traction. This considered view is based on its ease of use and the positive long lasting, clinically important benefits such as traction release, macular hole closure and non-surgical vision improvement that we have seen at the six month follow up stage. I am looking forward to playing an important role in the future development of this novel treatment.”
Prof. Desire Collen, CEO of ThromboGenics, commenting on today’s results said: “The follow-up results that have been generated with microplasmin in this study clearly show that it has the potential to play a major role in the treatment of a range of important diseases of the back of the eye. The commercial opportunity that these diseases represent along with the clinical profile of microplasmin that we have generated to-date, again reinforces the exciting potential of microplasmin for ThromboGenics.”
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.
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular 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 scheduled to enter a Phase Ib clinical trial in mid-2008 for the treatment of cancer. ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. 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.
CONTACT: For further information please contact: ThromboGenics, Prof.
Desire Collen, CEO, Dr. Patrik De Haes, COO, Tel: +32(0)16-34-61-94;
Citigate Dewe Rogerson, David Dible / Amber Bielecka / Sylvie Berrebi, Tel:
+44(0)207-638-95-71, sylvie.berrebi@citigatedr.co.uk
