LEUVEN, Belgium, April 1 /PRNewswire-FirstCall/ --
- Trial Results Expected Mid-2008
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular diseases, eye diseases and cancer, today announces that it has completed patient enrolment for its Phase IIb MIVI III trial in the United States. This study is designed to evaluate the safety and efficacy of Microplasmin in vitrectomy (MIVI III - Microplasmin for Vitreous Injection).
A vitrectomy is a surgical procedure carried out in the treatment of many back of the eye diseases such as retinal detachment, diabectic vitreous hemorrhage and macular hole. Vitrectomy is used to induce a posterior vitreous detachment (PVD) which involves removing the vitreous via suction. Microplasmin is a proteolytic enzyme that cleaves important molecules which link the vitreous to the retina and therefore has the potential to facilitate vitrectomy and induce PVD without the risks inherent in detachment by surgical intervention.
MIVI III is a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of Microplasmin (25, 75 and 125 ÃƒÂŽÃ‚Â¼g) versus placebo in 120 patients scheduled for vitrectomy. The trial is taking place across 19 sites throughout the United States and is assessing the safety and efficacy of Microplasmin intravitreal injection 7 days prior to vitrectomy. Top-line, unmasked results of this trial are expected in June 2008.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on today's announcement, said: "We are very pleased to have completed enrolment in our lead program. Microplasmin has the potential to significantly change the way we treat back of the eye diseases and this study will bring us a step closer to realising this potential. Due to encouraging safety and efficacy results obtained from both the MIVI I and MIVI II Traction Phase II trials which were conducted in Europe, we are confident that we will have further encouraging results from this trial."
Approximately 600,000 surgical vitrectomies are performed annually worldwide. The U.S. market accounts for more than 40% of treatments, and is growing at 6-8% per year. During a vitrectomy, three incisions are made through the white of the eye; the surgeon then inserts small instruments into the eye, cuts the vitreous gel, and suctions it out. There are certain risks inherent to this surgery including bleeding, infection, increased eye pressure, retinal detachment, and development of cataracts.
As Microplasmin could induce a PVD without the need for vitrectomy, it may serve as a more convenient, less invasive treatment option for certain eye conditions. For example, results from ThromboGenics' MIVI II Traction trial, which examined the safety and efficacy of Microplasmin in the treatment of vitreomacular traction showed that Microplasmin was able to resolve vitreomacular traction and even achieve closure of some macular holes, conditions that otherwise would have required vitrectomy.
Other major eye diseases that may benefit from nonsurgical PVD induction include diabetic retinopathy and age-related macular degeneration (AMD). Diabetic retinopathy is the leading cause of blindness among working-age adults, while AMD is the leading cause of blindness among the elderly.
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 such as 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 late 2008, and TB-403 (Anti-PlGF), which has begun Phase I clinical trials for the treatment of cancer. 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