ThromboGenics Announces that Microplasmin Meets Primary Endpoint in Phase III Trial for the Non-Surgical Treatment of Symptomatic Vitreomacular Adhesion (VMA)
LEUVEN, Belgium, April 20, 2010 /PRNewswire-FirstCall/ --
- Highly Significant Trial Result (p=0.003) Demonstrates the Potential of Microplasmin in the Treatment of Retinal Disease
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces that its first Phase III trial with microplasmin for the non-surgical treatment of eye disease has met its primary endpoint (p=0.003). The trial, TG-MV-006, recruited a total of 326 patients in the U.S. A second Phase III study with microplasmin, TG-MV-007, which recruited a similar number of patients in the U.S. and Europe, is due to report in the third quarter of 2010.
The microplasmin Phase III program, referred to as MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment), consists of two multi-center, randomized, placebo controlled, double-masked trials. These trials are designed to evaluate 125μg of microplasmin versus placebo in the intravitreal treatment of patients with symptomatic focal vitreomacular adhesion (VMA). The MIVI-TRUST program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders.
The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion one month after a single injection of microplasmin. This endpoint is being measured and recorded using optical coherence tomography (OCT), the standard method of assessment for this condition, which provides images that can clearly show the separation of the vitreous from the retina.
The results of the first trial, TG-MV-006, confirmed that it had met its primary endpoint with 27.7% of microplasmin treated patients achieving resolution of their VMA compared to 13.2% of patients treated with placebo injection (p=0.003). A Per Protocol analysis of the microplasmin treated patient population showed that 30.7% achieved resolution of their VMA (p=0.004).
In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period. These data will be presented at the World Ophthalmology Congress (WOC) in Berlin by Dr. Matthew Benz, MD (Baylor College of Medicine, Houston, Texas, U.S.).
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "This is the most important milestone in ThromboGenics' history. Microplasmin is key to the success of our ophthalmic focused strategy, and we are very pleased to be able to announce these positive results. The fact that microplasmin resolved VMA without surgery in approximately 30% of patients is a clinically important development. These results reaffirm our confidence in the potential of this innovative approach to the treatment of a range of retinal disorders. We are moving ahead with our pre-commercialization activities for microplasmin, so that we are well-positioned to launch this unique product successfully."
About Focal Vitreomacular Adhesion (VMA)
Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the macula, the center of the retina at the back of the eye. Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions, such as macular hole and some forms of macular edema. Vitreomacular adhesion is also associated with a poorer prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD).
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company's lead product microplasmin has completed its first Phase III clinical trial for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long acting anti-coagulant in Phase II, and TB-403 (anti-PlGF) in Phase I for cancer.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
For further information please contact:
ThromboGenic
Dr. Steve Pakola, CMO Tel: +1(212)201-0920
[email protected]
Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10
[email protected]
Citigate Dewe Rogerson
Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71
[email protected]
SOURCE ThromboGenics NV
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