Navigation Links
ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
Date:12/16/2009

LEUVEN, Belgium, December 16 /PRNewswire-FirstCall/ --

- MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over 640 patients Ahead of Schedule

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the second Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-007, which recruited patients both in Europe and the United States, has completed enrolment of over 320 patients across 48 centres, ahead of schedule.

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, which are taking place in the United States (TG-MV-006 trial) and in Europe and the United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.

The initial 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. 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 associated with a much poorer prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD). ThromboGenics recently started a Phase II study evaluating microplasmin in patients with AMD.

The primary endpoint of both of the MIVI-TRUST trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using Optical Coherence Tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period.

It is expected that the results from the first microplasmin Phase III study, the TG-MV-006 study will be presented in Q2 2010 and the results from the TG-MV-007 study in Q3 2010.

Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleased to announce that we have completed enrolment of our second pivotal Phase III trial for microplasmin, ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is encouraging. We very much look forward to announcing the first results from our MIVI-TRUST Phase III program by mid 2010."

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines 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 conditions. In addition, ThromboGenics is 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. 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.

    For further information please contact:

    ThromboGenics

    Dr. Patrik De Haes, CEO                   Tel: +32-16-75-13-10
                                              patrik.dehaes@thrombogenics.com

    Dr. Steve Pakola, CMO                     Tel: +1-212-201-0920
                                              steve.pakola@thrombogenics.com

    Citigate Dewe Rogerson

    Amber Bielecka/David Dible/Nina Enegren   Tel: +44(0)207-638-95-71
                                              amber.bielecka@citigatedr.co.uk

SOURCE ThromboGenics NV


'/>"/>
SOURCE ThromboGenics NV
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. ThromboGenics Completes Patient Enrolment in the Phase IIb Trial of Microplasmin in Vitrectomy (MIVI III)
2. ThromboGenics Announces Promising Results of MITI IV Phase II Trial in the Treatment of Acute Stroke with Microplasmin
3. ThromboGenics Begins Phase III Program With Microplasmin for the Non-surgical Treatment of Back of the Eye Disease
4. ThromboGenics and BioInvent Receive Technology Transfer Success Fee From Roche for the Novel Anti-Cancer Antibody, TB-403 (Anti-PIGF)
5. ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
6. ThromboGenics Microplasmin Phase III Program Progressing According to Schedule
7. ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402
8. ThromboGenics Completes Patient Enrolment in US Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
9. ThromboGenics and BioInvent Complete Patient Recruitment of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)
10. ThromboGenics Announces Start of Phase II Trial of Microplasmin for the Treatment of Age-Related Macular Degeneration (AMD)
11. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... -- Treato , the single largest ... that it has been named a Cool Vendor by ... Sciences, 2016, Stephen Davies , Michael ... life-science- oriented analytics, algorithms and smart machine technology in ... medication ingestion, and analyze unstructured information.   ...
(Date:4/28/2016)... Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ) ( ... of oral drug delivery systems, announced today that the Company ... Joseph Gunnar & Co. LLC, taking place on ... Nadav Kidron , CEO of Oramed, will present a ...   PIONEERS 2016, presented by Joseph Gunnar ...
(Date:4/28/2016)... TapImmune,Inc. (TPIV), a clinical-stage immune-oncology company ... and vaccines for the treatment of cancer & metastatic disease, ... Growth Capital Expo to be held on May 3 ... in Las Vegas, Nevada.  The Company presentation will be ... by Dr. John N. Bonfiglio a TapImmune Board ...
Breaking Medicine Technology:
(Date:5/2/2016)... ... May 02, 2016 , ... Pets bring laughter, joy and love ... pet owners celebrate National Pet Week, which falls on the first full week of ... to cherish the human-animal bond and recognize responsible pet ownership. Pet owners can live ...
(Date:5/2/2016)... ... May 02, 2016 , ... “Engineering Bubbles,” an oil painting submitted by Canadian ... Forum held recently at the Annual Meeting in Los Angeles. The first annual art ... members and Annual Meeting attendees. , “Through art I hope to educate people ...
(Date:5/2/2016)... ... May 02, 2016 , ... Over $60 Billion is spent ... pet gear and toys, leading product review site for Toys, Tots, Pets & More ... at their Spring Showcase at the Metropolitan Pavilion in New York City. , ...
(Date:5/2/2016)... NV (PRWEB) , ... May 02, 2016 , ... ... Pharmacy Times, has announced a new Specialty Pharmacy Patient Satisfaction Award that will ... based on the quarterly results from Zitter Health Insights’ Specialty Pharmacy Patient Satisfaction ...
(Date:5/2/2016)... ... May 02, 2016 , ... According to an American Psychological ... girls are sexually abused before the age of 18. Of those who survive, many ... story and others. , In her new book, Lyah! Lyah! Pants on Fyah!, ...
Breaking Medicine News(10 mins):