BioWorld International Correspondent
BRUSSELS, Belgium - ThromboGenics has initiated a Phase IIb clinical trial of microplasmin in vitrectom in the U.S.
For ThromboGenics NV, of Leuven, Belgium, the trial is a crucial stage in its development of microplasmin, one of its leading candidate products.
The MIVI III (Microplasmin for Vitreous Injection III) trial is a Phase IIb multicenter, randomized, placebo-controlled, double-masked, dose-ranging clinical trial evaluating the safety and efficacy of microplasmin intravitreal injection prior to vitrectomy. The trial involves 120 patients who will be treated at more than 12 sites throughout the U.S. The results are expected to allow dose selection for subsequent Phase III clinical development.
Microplasmin is a truncated form of the natural human protein plasmin, and ThromboGenics has developed the first stabilized and readily manufactured form of that molecule.
ThromboGenics also is starting Phase II development in Europe of microplasmin injection, to evaluate it for non-surgical treatment of diabetic macular edema and other back-of-the-eye conditions that 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 enrollment.
Désiré Collen, CEO of ThromboGenics, said, "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.
Those 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 practice, the induction of posterior vitreous detachment is achieved via surgical vitrectomy in some 600,000 cases per year worldwide. Microplasmin eases this invasive approach. Prior administration facilitates surgical vitrectomy and can reduce complications.