LEUVEN, Belgium, December 16 /PRNewswire-FirstCall/ --
- MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over 640 patients Ahead of Schedule
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 today that it has completed the enrolment of the second Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-007, which recruited patients both in Europe and the United States, has completed enrolment of over 320 patients across 48 centres, ahead of schedule.
Microplasmin's Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. This program involves two clinical trials, which are taking place in the United States (TG-MV-006 trial) and in Europe and the United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.
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. 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 associated with a much poorer prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD). ThromboGenics recently started a Phase II study evaluating microplasmin in patients with AMD.
The primary endpoint of both of the MIVI-TRUST trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using Optical Coherence Tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. 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.
It is expected that the results from the first microplasmin Phase III study, the TG-MV-006 study will be presented in Q2 2010 and the results from the TG-MV-007 study in Q3 2010.
Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleased to announce that we have completed enrolment of our second pivotal Phase III trial for microplasmin, ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is encouraging. We very much look forward to announcing the first results from our MIVI-TRUST Phase III program by mid 2010."
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 is in Phase III clinical development 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, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. 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: ThromboGenics Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 email@example.com Dr. Steve Pakola, CMO Tel: +1-212-201-0920 firstname.lastname@example.org Citigate Dewe Rogerson Amber Bielecka/David Dible/Nina Enegren Tel: +44(0)207-638-95-71 email@example.com
SOURCE ThromboGenics NV
|SOURCE ThromboGenics NV|
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