Navigation Links
ThromboGenics Completes Patient Enrolment of MITI IV Trial, a Phase II Study Evaluating the Safety and Preliminary Efficacy of Microplasmin in the Treatment of Acute Stroke
Date:4/8/2008

LEUVEN, Belgium, April 9 /PRNewswire-FirstCall/ -- 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 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 prospectus.


'/>"/>
SOURCE ThromboGenics NV
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. ThromboGenics Announces 2007 Full Year Results
2. ThromboGenics and BioInvent Receive Approval to Begin Clinical Trials of TB-403 for the Treatment of Cancer
3. ThromboGenics Presents Results of the Phase I Trial of TB-402 at the Prestigious American Society of Hematology Annual Meeting
4. ThromboGenics Presents Results of the Vitreomacular Traction Trial (MIVI IIT) at the American Society of Retina Specialists Annual Meeting
5. ThromboGenics and BioInvent Announce Publication of Exciting Data on a Novel Class of Angiogenesis Inhibitors in Cell
6. ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402
7. ThromboGenics Announces Successful Completion of Technology Transfer to Bharat Biotech for Production of Novel Thrombolytic Agent
8. ThromboGenics - Business Update and Interim Results for the Seven Month Period Ending 30 June 2007
9. Compressus Completes Interoperability Implementation for E-Rad Solutions Teleradiology Customers
10. Core Informatics Completes Successful LIMS Implementation for Progenics Pharmaceuticals
11. Alexza Completes $10 Million Equity Financing with Bio*One Capital to Initiate Commercial Manufacturing in Singapore
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)...  Liquid Biotech USA , ... Sponsored Research Agreement with The University of Pennsylvania ... cancer patients.  The funding will be used to ... clinical outcomes in cancer patients undergoing a variety ... employed to support the design of a therapeutic, ...
(Date:6/24/2016)... June 24, 2016  Regular discussions on a range of ... between the two entities said Poloz. Speaking at ... Ottawa , he pointed to the country,s inflation target, ... government. "In certain ... institutions have common economic goals, why not sit down and ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and ... and the 6000i models are higher end machines that use the more unconventional z-dimension ... light beam from the bottom of the cuvette holder. , FireflySci has developed ...
(Date:6/23/2016)... ... 23, 2016 , ... Mosio, a leader in clinical research ... Recruitment and Retention Tips.” Partnering with experienced clinical research professionals, Mosio revisits the ... tools, and strategies for clinical researchers. , “The landscape of how patients receive ...
Breaking Biology Technology:
(Date:6/22/2016)... BETHESDA, Md. , June 22, 2016  The American ... by Trade Show Executive Magazine as one of ... Summit on May 25-27 at the Bellagio in ... based on the highest percentage of growth in each of ... number of exhibiting companies and number of attendees. The 2015 ...
(Date:6/20/2016)... 20, 2016 Securus Technologies, a leading ... for public safety, investigation, corrections and monitoring announced ... it has secured the final acceptance by all ... Managed Access Systems (MAS) installed. Furthermore, Securus will ... be installed by October, 2016. MAS distinguishes between ...
(Date:6/9/2016)... , June 9, 2016 ... deploy Teleste,s video security solution to ensure the safety of ... during the major tournament Teleste, an ... systems and services, announced today that its video security solution ... to back up public safety across the country. The ...
Breaking Biology News(10 mins):