ThromboGenics' Microplasmin Phase III Program Progressing According To Schedule

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Jun 2009 - 2:00 PDT

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ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces that its lead product microplasmin, which is in Phase III trials for the treatment of vitreomacular adhesion, is progressing according to schedule. All protocol-specified, interim masked analyses by the independent Data Monitoring Committee (DMC) have been completed. Recruitment is on track and the DMC, having found no safety concerns, has unanimously recommended proceeding without protocol modification.

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, taking place in the United States (TG-MV-006 trial) and Europe and the United States (TG-MV-007 trial). The 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).

Both of the Phase III studies are multi-centre, randomized, placebo controlled, double-masked trials which will evaluate 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol a total of 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 safety review was the final of two safety reviews, and had been scheduled to take place after 50% of patients had been enrolled in one of the studies.

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion within 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. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on the announcement said, "We are very pleased that the Phase III program for microplasmin is progressing well and that enrolment is on track. We remain confident that microplasmin could potentially make a significant difference to the treatment of back of the eye disease and we very much look forward to reporting the results from these trials."

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and development of innovative 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. The Company is listed on Eurolist by Euronext Brussels under the symbol THR.

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