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Results confirm microplasmin’s potential to make a major contribution to the treatment of back of the eye disease
Leuven, Belgium | June 30, 2008 | ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on eye disease, vascular disease and cancer, today announces positive results from its Phase IIb MIVI III trial that was designed to evaluate the safety and efficacy of microplasmin in vitrectomy. The MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial showed that the most effective dose of microplasmin studied (125 μg) was able to resolve the underlying disease in approximately 30% of patients without the need for a vitrectomy. The encouraging results from this study were presented by Dr.
George Williams (Beaumont Hospital, Michigan, USA) on June 28 at the World Ophthalmology Congress in Hong Kong.
A vitrectomy is a surgical procedure carried out in the treatment of many important back of the eye diseases such as retinal detachment, diabetic vitreous hemorrhage and macular hole. A vitrectomy is used to induce a posterior vitreous detachment (PVD), which involves removing the vitreous via suction so that it is no longer attached to the retina.
Microplasmin is an enzyme that cleaves important protein molecules which link the vitreous to the retina and therefore has the potential to facilitate vitrectomy and pharmacologically induce PVD, without the risks inherent in detaching the vitreous by surgical intervention.
The MIVI III trial is a Phase IIb, randomized, double-masked, placebo-controlled, doseranging trial evaluating three doses of microplasmin (25, 75 and 125 μg) versus placebo in 125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the United States. The trial was designed to assess the safety and efficacy of microplasmin intravitreal injection given 7 days prior to the patient’s planned vitrectomy.
The study showed that microplasmin was well tolerated. The trial also showed a clear dose response curve with the highest 125 μg dose of microplasmin delivering the best results. In this group, 10 of the 32 patients receiving this dose of microplasmin had resolution of their underlying disease and therefore did not need a vitrectomy (surgical intervention) for the indication for which they were being treated. This compares very favourably with the placebo group, where only 1 patient out of 31 achieved the same positive outcome, and the 75 μg microplasmin treated group, where 5 patients out of 33 did not need a vitrectomy. In addition, use of microplasmin was associated with a reduced amount and duration of suction needed to achieve a PVD in patients who progressed to surgical intervention, compared to placebo.
The visual acuity of all of the patients recruited into the study was also measured at day 35 after the injection of microplasmin or placebo, whether they had a vitrectomy or not. In patients who received the highest 125 μg dose of microplasmin there was an improvement in vision (6.9 more letters read on a standard eye chart compared to a baseline reading prior to treatment); this compares with a 4.7 letter improvement for all microplasmin treated patients and a 0.1 letter improvement for the placebo group.
ThromboGenics has decided to proceed into Phase III clinical development of microplasmin based on these encouraging results. The microplasmin Phase III development program is expected to begin in late 2008/early 2009 following an End of Phase II Meeting with the FDA later this year. It is anticipated that this Phase III development program will use 125 μg dose of microplasmin.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on today’s announcement, said: “We are very pleased with the confirmatory results obtained in the Phase IIb MIVI III trial. The ability of the highest 125 μg dose of microplasmin to safely
induce a PVD in approximately 30% of patients, without the need for surgical intervention, confirms its potential to significantly change the treatment of a range of important back of the eye diseases. The results build on the encouraging safety and efficacy results that we obtained from both the MIVI I and MIVI II Traction Phase II trials, and we feel that we are now well positioned to commence our Phase III development program with microplasmin.”
About Vitrectomy
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. 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.
SOURCE: ThromboGenics NV |
