ThromboGenics Announces Promising Results Of MITI IV Phase II Trial In The Treatment Of Acute Stroke With Microplasmin

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 30 Sep 2008 - 0:00 PDT

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ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on novel therapies for eye disease, vascular disease and cancer, announces positive results from its MITI IV Phase II trial to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients. The trial showed that microplasmin was generally well tolerated and also provided some interesting preliminary efficacy data. The overall results of the study were presented by Dr. Vincent Thijs on September 27 at a Late-Breaking Clinical Trial session at the World Stroke Congress.

The MITI IV (Microplasmin In Treatment of Ischemic stroke - IntraVenous) trial was a Phase II, multicentre, randomized, double-blinded, placebo-controlled, ascending-dose clinical trial evaluating the safety and preliminary efficacy of the intravenous administration of microplasmin in 40 patients, 4 to 12 hours after onset of acute ischemic stroke. The trial investigated three dose regimens of microplasmin (2, 3, and 4 mg/kg total dose) compared to placebo. Clinical outcomes were assessed at seven days and 30 days post-treatment, and at each of these visits neurological assessments were performed.

The study found that microplasmin was generally well tolerated with no evidence of increased bleeding risk; there were no systemic bleeding events reported and there was no evidence of increased rate of bleeding in general, in those patients that had been treated with microplasmin compared to those treated with placebo.

In addition, the study provided some interesting preliminary efficacy results. Approximately 25% of patients treated with microplasmin had reperfusion (restoration of blood flow) within eight hours of being treated, this compares with 10% of placebo-treated patients. Moreover, of the patients who had more severe vascular blockages, 33% of patients treated with microplasmin achieved reperfusion compared with 14% of placebo-treated patients. Due to the small number of patients in this study, neither of these end points were statistically significant. However, the study also showed that microplasmin-treated patients had a statistically significant improvement in the level of damage to the blood brain barrier compared to placebo-treated patients, measured using the marker of matrix metalloproteinase (MMP). MMP activation plays a crucial role in the pathogenesis of brain edema and hemorrhagic transformation after ischemic stroke.

Professor Vincent Thijs, Lead Principal Investigator of the trial, commenting on the results said, "I am delighted that we were able to present these interesting results at the World Stroke Congress. The results show that microplasmin is safe and generally well tolerated with no evidence of increased bleeding risk. Moreover, the results also support previous preclinical studies that have shown that microplasmin is able to lyse clots and may also have certain vascular protective properties."

Dr. Patrik De Haes, CEO of ThromboGenics, commenting on today's announcement said: "I am very pleased that we have been able to successfully conclude this study of microplasmin in patients with stroke. The results that have been reported show that the product is well tolerated and could potentially be of benefit in this indication of high medical need. However, as we have stated previously, our current view is that it only makes sense for ThromboGenics to move forward with the development of microplasmin for vascular indications in cooperation with a partner, given the costs and risks involved. We believe that by focusing on the development of microplasmin for eye disease, where we have already generated encouraging clinical data, and carefully utilizing our resources on the other opportunities in our pipeline, we will continue to generate a high return for ThromboGenics' shareholders."

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 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. 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 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.

ThromboGenics NV
http://www.thrombogenics.com