LEUVEN, Belgium, January 8 /PRNewswire/ -- ThromboGenics NV , a biotechnology company focused on vascular disease, announces that it has initiated a Phase IIb clinical trial of Microplasmin in vitrectomy (MIVI III - Microplasmin for Vitreous Injection) in the United States. The Company had previously announced that it had received IND clearance from the FDA to proceed with this trial.
The MIVI III (Microplasmin for Vitreous Injection III) trial is a Phase IIb multi-center, randomized, placebo-controlled, double-masked, dose-ranging clinical trial evaluating the safety and efficacy of microplasmin intravitreal injection prior to vitrectomy. 120 patients will be treated in this trial at over 12 sites throughout the U.S. The results of this trial are expected to allow dose selection for subsequent Phase III clinical development.
In parallel with this Phase IIb trial, ThromboGenics will proceed with Phase II development in Europe to evaluate microplasmin injection for the non-surgical treatment of diabetic macular edema and other back of the eye conditions. These conditions may benefit from microplasmin without need for vitrectomy. The first of these studies, the MIVI II trial, evaluating patients with diabetic macular edema, has started patient enrolment.
Prof. Desire Collen, CEO of ThromboGenics, commenting on today’s announcement, said: “Initiation of these two studies before the end of 2006 demonstrates our commitment to advancing microplasmin in the eye field so that we can capture this exciting product’s broad potential. The decision to move forward quickly is based on encouraging safety and efficacy results obtained from the Phase IIa trial (MIVI I) which evaluated Microplasmin in vitrectomy in Europe. These results support not only advancement into Phase IIb development for the vitrectomy indication (MIVI III) but also expansion of the program to evaluate potential of microplasmin to treat important vitreoretinal diseases such as diabetic retinopathy non-surgically (MIVI II).”
In current clinical practice, the induction of posterior vitreous detachment (PVD) is achieved via surgical vitrectomy, whereby the vitreous gel in the center of the eye is intentionally removed from the retina for the treatment of a variety of retinal disorders, commonly referred to as diseases of the “back of the eye,” including diabetic retinopathy. However, given the difficulties inherent in detaching the vitreous by surgical vitrectomy, there is a great desire for an improved approach to achieving PVD in a minimally invasive way. The approach that is being studied in the MIVI III trial (US Phase IIb vitrectomy trial) is to administer a drug - microplasmin - prior to surgical vitrectomy in order to facilitate the induction of PVD, as this may result in a more rapid surgery with fewer complications. The MIVI II trial (European Phase II DME trial) will evaluate the ability of microplasmin to treat diabetic macular edema without requiring vitrectomy.
Microplasmin is a truncated form of the natural human protein plasmin; ThromboGenics has developed on a proprietary basis the first stabilized and readily manufactured form of this molecule. Microplasmin is being developed for multiple indications of which its use for treatment of vitreoretinal disorders is ThromboGenics’ most advanced program.
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. In addition to its potential benefits in the setting of vitrectomy, microplasmin may also allow for nonsurgical treatment of certain vitreoretinal disorders, such as macular edema and diabetic retinopathy.
Diabetic retinopathy is the leading cause of blindness among working-age adults.
For further information please contact: ThromboGenics Prof Desire Collen, CEO Tel: +32-(0)-16-34-61-94 Citigate Dewe Rogerson David Dible / Valerie Auffray Tel: +44-(0)-207-638-95-71 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 also has five other drug candidates in preclinical development with preclinical proof-of-principle demonstrated, including TB-402 (Anti-Factor VIII) and TB-403 (Anti-PlGF). The Company 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 Ireland and the U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at 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.
ThromboGenics NV
CONTACT: ThromboGenics, Prof Desire Collen, CEO, Tel: +32-(0)-16-34-61-94,Citigate Dewe Rogerson, David Dible / Valerie Auffray, Tel:+44-(0)-207-638-95-71
