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LEUVEN, Belgium, April 9LEUVEN, Belgium, April 9 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular diseases, eye diseases and cancer, announces today that it has completed patient enrolment for its Phase II MITI IV study. The primary purpose of this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients between four and twelve hours after the onset of the stroke.
MITI IV (Microplasmin in Treatment of Ischemic stroke - IntraVenous) is a Phase II, multicentre, double-blinded, placebo-controlled, ascending-dose clinical trial evaluating the safety of the intravenous administration of microplasmin in 40 patients with acute ischemic stroke. The trial is investigating three dose regimens of microplasmin (2, 3, and 4 mg/kg total dose) and placebo. The trial is also designed to provide preliminary efficacy data using radiographic assessments and plasma surrogate biomarkers. Clinical outcomes are assessed at seven days and 30 days post-treatment, and at each of these visits neurological assessments are performed.
Microplasmin is a truncated form of the natural human protein plasmin, which plays a key role in dissolving blood clots such as those that cause acute stroke. It is a direct-acting thrombolytic agent that has the potential to restore blood flow efficiently within an extended period after a stroke event and has potentially fewer side-effects than other thrombolytic agents. Currently the only approved pharmacologic treatment of acute ischemic stroke is tPA, an indirect-acting thrombolytic. However tPA must be administered within three hours after the stroke has occurred and has the risk of causing unwanted bleeding events.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on today's announcement said: "I am very pleased that we have completed enrolment in this study. We look forward to the results, which should be available by the middle of this year. Once we have reviewed the data from this study, we will decide on our future development plans with microplasmin for the treatment of acute stroke."
About Stroke
Stroke is a cardiovascular disease affecting the blood vessels of the brain. Stroke is caused by a blockage of the blood vessels of the brain, depriving the brain of oxygen, and can result in severe neurological damage and death. After heart diseases and cancer, stroke is the third most frequent cause of death and the leading cause of disability in the Western world. It is estimated that over two million people suffer a stroke annually. Mortality is high with 20% of patients dying, while the majority of the remainder are left permanently disabled.
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases such as acute stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical development in late 2008, and TB-403 (Anti-PlGF), which has begun Phase I clinical trials for the treatment of cancer. ThromboGenics has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. 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 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 prospectus.
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