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news.Trial is to evaluate microplasmin in patients with diabetes
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ThromboGenics has revealed the results of phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema.
The company said that the 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.
According to the company, 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.
ThromboGenics revealed 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 75ug dose group had total PVD.
Steve Pakola, CMO of ThromboGenics, said: “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.”
ThromboGenics discovers and develops medicines for the treatment of eye disease, vascular disease and cancer. The company is also developing new antibody therapeutics in collaboration with BioInvent International; these include TB-402, a long acting anti-coagulant, and TB-403 for cancer.