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ThromboGenics Begins Phase III Program With Microplasmin for the Non-surgical Treatment of Back of the Eye Disease

Posted on: Friday, 9 January 2009, 00:00 CST

LEUVEN, Belgium, January 9 /PRNewswire-FirstCall/ --

- ThromboGenics' Lead Product to be Studied in the Treatment of Vitreomacular Adhesion in the US and Europe

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."

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals 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 indications and as a potential therapy for stroke. ThromboGenics is also 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 and has subsidiaries in Dublin, Ireland and New York, U.S. 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.

SOURCE ThromboGenics NV

Source: PR Newswire

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