ThromboGenics Completes Enrolment of Patients for the Vitreomacular Traction Trial (MIVI IIT)
- Category: Proteins and Peptides
- Published on Saturday, 22 September 2007 04:00
- Hits: 2020
LEUVEN, Belgium | September 21, 2007 | ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular diseases, today announces that it has completed patient enrolment for the Phase IIa MIVI IIT trial evaluating the safety and efficacy of microplasmin for the treatment of vitreomacular traction, including macular holes.
Vitreomacular traction is a condition in which the vitreous gel has an abnormally strong adhesion to the retina and could lead to decreased or distorted central vision as well as vision threatening complications such as retinal tears/detachments and macular holes. These conditions are currently treated by surgical vitrectomy (surgery that removes the vitreous to induce posterior vitreous detachment, or PVD) to release the traction.
MIVI IIT is a Phase IIa, sham injection controlled, dose ascending (75, 125 μg) trial, which recruited a total of 30 patients in Europe. The lead investigator for this trial is Professor Peter Stalmans from Leuven, Belgium. While the study remains masked, initial data showed that microplasmin was well tolerated in both treatment cohorts. Additionally, PVD induction was observed in a number of patients and in some cases led to the non-surgical resolution of traction and even macular hole closure with improvement in vision, preventing the need for vitrectomy. This preliminary examination of patients shows that microplasmin has the potential to relieve the traction and prevent the need for surgery.
Unmasked results for the MIVI II Traction trial will be presented by Prof. Peter Stalmans on December 04, 2007 at the ASRS (American Society of Retina Specialists) annual meeting in Indian Wells, CA, USA.
In addition, similar encouraging findings of patients successfully treated without vitrectomy are being reported in the MIVI III trial (microplasmin in surgical vitrectomy), a separate trial which is currently ongoing. MIVI III is a placebo-controlled trial which is being performed in the U.S. in patients scheduled to undergo vitrectomy. Encouraging cases observed in the MIVI III trial will be presented by Dr. David Brown, an investigator of the MIVI III trial, at the Retina Society Annual Meeting, 27 September, Boston, USA.
Prof Désiré Collen, CEO of ThromboGenics, commenting on today’s announcement, said: “We are very pleased to announce the completion of the enrolment of patients for the MIVI IIT trial and to already have such encouraging and exciting patient cases. To be able to make case presentations at ophthalmology conferences is a tribute to the potential of microplasmin for the treatment of back of the eye disorders. We look forward to the confirmation of these encouraging results with the full analysis of the MIVI IIT trial later this year.”
About Vitreomacular Traction
Numerous conditions are associated with vitreomacular traction which may lead to decreased vision and/or complications. These include macular hole, macular edema (ME) associated with vitreomacular traction, and vitreomacular traction syndrome (VTMS). The only available treatment for these conditions is surgical vitrectomy, in order to induce a posterior vitreous detachment (PVD) and thereby alleviate the vitreomacular traction. Therefore, a pharmacological agent that could induce PVD nonsurgically would be a dramatic advance for the treatment of these conditions, preventing the need for surgery and its associated cost, inconvenience and risk of complications. Macular hole prevalence is approximately 0.14% of general population, leading to estimates of approximately 400,000 cases in the US and of up to 1 million in the industrialized world.
Other potential nonsurgical applications for microplasmin include treatment of macular edema and diabetic retinopathy. Diabetic retinopathy is the leading cause of blindness among working-age adults while diabetic macular edema (DME) is the leading cause of decreased vision in patients with diabetic retinopathy. Around 750,000 patients suffer from DME in the United States alone.
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 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 2008, and TB-403 (Anti-PlGF) which is expected to proceed to Phase I clinical trials by the end of 2007. 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 www.thrombogenics.com.