THROMBOGENICS BEGINS PHASE II TRIALS WITH MICROPLASMIN

ThromboGenics has initiated a Phase IIb clinical trial of microplasmin in vitrectomy, or surgical removal of the vitreous from the eye, in the United States. The MIVI III trial is a Phase IIb multicenter, randomized, placebo-controlled, double-blind, dose-ranging clinical trial evaluating the safety and efficacy of microplasmin intravitreal injection prior to vitrectomy. A total of 120 patients will be treated in this trial at 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 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.

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, including diabetic retinopathy. However, there is a call for an improved approach to achieving PVD in a minimally invasive way, according to the company. The approach that is being studied in the MIVI III trial is to administer 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 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 that ThromboGenics has developed as the first stabilized and readily manufactured form of this molecule.