THROMBOGENICS STARTS PHASE IIA OF MICROPLASMIN FOR STROKE.ThromboGenics NV (Euronext Brussels: THR Thr threonine. Thr abbr. threonine Thr threonine. ), Leuven, Belgium, a biotechnology company focused on vascular disease, has initiated a Phase IIa clinical trial to evaluate microplasmin for the intra-arterial treatment of stroke. The study, which is called the Microplasmin MITI-IA Trial (Microplasmin In Treatment of Ischemic Stroke - Intra-Arterial), is the second study that ThromboGenics has initiated to assess the benefits of microplasmin for the treatment of acute ischemic stroke. The first study, called MITI-IV, is evaluating the intra-venous administration of microplasmin for the treatment of acute stroke. Preliminary results from the MITI-IV trial, which is ongoing, are expected to be available in the second half of 2007. The Phase IIa MITI-IA study will enroll up to 20 patients with acute vertebro-basilar artery occlusion, a subset of acute stroke patients who have a particularly high mortality rate. This population was selected for this study because it is thought that a direct-acting thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. such as microplasmin may prove more beneficial in these severe strokes when compared to indirect-acting thrombolytics such as tPA. The trial will be conducted at three centers in Germany. The main purpose of this second Phase IIa study is to obtain initial safety information in the acute stroke patient population, and to demonstrate the ability of microplasmin to efficiently dissolve the blood clot blood clot n. A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network. and restore blood flow to the brain. Such a finding would serve as clinical proof-of-concept for the development of intra-arterial administration of microplasmin for the treatment of acute ischemic stroke. Microplasmin is a truncated form of the natural human protein plasmin plasmin /plas·min/ (plaz´min) an endopeptidase occurring in plasma as plasminogen, which is activated via cleavage by plasminogen activators; it solubilizes fibrin clots, degrades other coagulation-related proteins, and can be activated that plays a key role in dissolving blood clot. ThromboGenics has developed on a proprietary basis the first stabilized and readily manufactured form of this molecule. Microplasmin is being developed for multiple indications of which use for treatment of vitreoretinal disorders is ThromboGenics' most advanced program. Prof. Desire Collen, ThromboGenics' CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , commenting on the announcement, said: "I am pleased that we are continuing to expand our clinical development program in the field of acute stroke. It is clear that there is a dramatic need for improved thrombolytics for the treatment of this devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. disease. The study that we have announced today, which is evaluating the intra-arterial administration of microplasmin, is designed to demonstrate the rapid lytic lytic /lyt·ic/ (lit´ik) 1. pertaining to lysis or to a lysin. 2. producing lysis. lyt·ic adj. 1. Of, relating to, or causing lysis. 2. action of this unique direct-acting thrombolytic in the setting of acute ischemic stroke. In addition, we are hopeful that we see an excellent safety profile given the product's rapid inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. in the bloodstream. Based on my and the company's significant experience in the field of thrombolytic agents, I am optimistic that microplasmin could represent a major advance in the treatment of this very important disease." ThromboGenics is evaluating microplasmin for a range of thrombotic diseases including stroke and peripheral vascular occlusion. About Stroke Stroke is a form of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease affecting the blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. of the brain. Stroke is caused by a blockage or a rupture of the blood vessels of the brain, depriving the brain of oxygen and causing severe neurological damage and death. After heart diseases and cancer, stroke is the third most frequent cause of death in the Western world. It is estimated that over 2 million people suffer a stroke annually. Mortality is high with 20% of patients dying, while the majority of the remainder are left permanently disabled. Stroke can be subdivided into two types: * Ischemic stroke: caused by blockage of the brain blood vessels due to clot formation and accounting for approximately 84% of all stroke cases. * Hemorrhagic stroke hemorrhagic stroke Neurology An ischemic stroke in which blood enters necrotic brain tissue, which may not be accompanied by a worsening clinical status Risks for HS Hemophilia, thrombocytopenia, sickle cell anemia, DIC, anticoagulants, HTN. See Stroke. : caused by the rupturing of weakened blood vessels in the brain which causes bleeding into the surrounding tissue. 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 occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. diseases, including acute stroke. ThromboGenics also has five other drug candidates in preclinical development with preclinical proof-of-principle demonstrated, including TB-402 (Anti-Factor VIII) and TB-403 (Anti-PlGF). The company 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 Ireland and the U.S. The company is listed on Eurolist by Euronext Brussels under the symbol THR. For more information, visit http://www.thrombogenics.com. |
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