Oct 6 2009
- Data Presented at the American Society of Retina Specialists (ASRS) Conference in New York
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, today announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). The data from this trial were presented at the ASRS (American Society of Retina Specialists) Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Previous studies in this advanced patient population have shown that, given the underlying condition, the adhesion between the vitreous and retina tends to be much stronger, as evidenced during vitrectomy. This level of adhesion makes it more challenging to achieve a total PVD in patients with advanced DME, as opposed to earlier stage diabetic retinopathy.
The MIVI II DME trial was a Phase IIa, randomized, double masked, sham injection controlled, dose ascending clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin (25, 75 and 125 micro g) for the treatment of patients with Diabetic Macular Edema, a particular form of diabetic retinopathy. The efficacy endpoint was the induction of posterior vitreous detachment (PVD), as assessed by the principal investigator (PI) and the Central Reading Center (CRC) based on ultrasonography. The trial recruited 51 patients across Europe. Patients enrolled in this trial had advanced DME, as evidenced by prior laser treatment in 46% of the sham patients and 76% of the microplasmin-treated patients.
The data showed that microplasmin was safe and well tolerated. The principal investigators found that within three days after microplasmin injection, a total PVD in two out of 15 patients was observed in the 125ug dose group, and by day 28, two additional patients out of 15 in the 75 ug dose group had total PVD. The investigators did not observe total PVD by day 28 in any patients who received 25 micro g of microplasmin or the sham injection. The PI results were regarded as giving the most accurate view of microplasmin's efficacy in this study, due to inherent limitations in the CRC assessment,
Professor Peter Stalmans commenting on the results said, "The results of this trial are encouraging and show that microplasmin is able to non-surgically induce release of vitreomacular adhesion in some DME patients. Moreover, the fact that we have been able to show some evidence of biologic activity with the higher doses of microplasmin in patients with such advanced DME demonstrates microplasmin's potential in the wider diabetic retinopathy population. This combined with the excellent safety suggests that further studies are warranted in diabetic patients."
Dr Steve Pakola, CMO of ThromboGenics, added, "This trial has been a good starting point in assessing the utility of microplasmin treatment of diabetic retinopathy. We will finalise the next step in the development plan for microplasmin in this patient population once we have the results from the first Phase III trial (TG-MV-006), which are anticipated by mid-2010. The results from this 326 patient trial will provide us with a significant amount of additional data that will help us to refine our development plans for microplasmin in patients with diabetic retinopathy."
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