ThromboGenics Begins Trial For Non-Surgical Eye Disease Treatment
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on innovative treatments for eye disease, vascular disease and cancer, announces today that it has started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease, the final step in the clinical development of this potential new therapy. This program involves two clinical trials, taking place in the United States (TG MV-006 trial) and Europe and North America (TG-MV-007 trial). The start of these pivotal clinical trials represents an important step in potentially improving the treatment of back of the eye disease, and is a major milestone in ThromboGenics' corporate development.
Microplasmin's pivotal Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program.
The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion which results in deterioration in the patient's vision. Moreover, vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions such as macular hole formation, and some forms of macular edema. Vitreomacular adhesion is also potentially associated with a much poorer prognosis in certain major eye indications, including diabetic retinopathy and Age-related Macular Degeneration (AMD).
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on the announcement said, "Intravitreal injection of microplasmin is a unique approach to treating back of the eye disease. Microplasmin may represent an important clinical advance as earlier clinical studies have shown that it could potentially resolve vitreomacular adhesion in a simple one-off procedure, removing the need for major eye surgery with its associated risks and costs in such cases. In addition, we believe microplasmin has potential for treatment of other conditions such as diabetic retinopathy and AMD, given the increasing evidence that vitreomacular adhesion plays an important part in these sight-threatening conditions."
Both trials are multi-centre, randomized, placebo controlled, double-masked trials which will evaluate 125 micrograms of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol approximately 320 patients each across approximately 40 centres in the United States (TG-MV-006) and 40 centres in Europe and North America (TG-MV-007).
The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. Additional measures of efficacy and safety will also be assessed at various intervals over six months in both studies. It is estimated that these two studies will be completed by the end of 2010.
Dr. Patrik De Haes, CEO of ThromboGenics, commenting on the announcement said,
"I am very pleased to announce the start of the Phase III trials of microplasmin for the non-surgical treatment of vitreomacular adhesion. We have been very encouraged by the results we have seen in our Phase II program, and believe that microplasmin has the potential to make a significant difference to the treatment of back of the eye diseases. During the last twelve months, ThromboGenics made considerable progress in maximising the value of the Company's pipeline, and the start of these trials represent another important milestone in our corporate development. We look forward to advancing these two important studies and ensuring that ThromboGenics continues to enjoy further success in 2009."