Navigation Links
ThromboGenics Completes Patient Enrolment in US Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
Date:9/23/2009

LEUVEN, Belgium, September 24 /PRNewswire-FirstCall/ --

- Enrolment of 326 Patients Completed 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 US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-006 has completed enrolment with a total of 326 patients several months ahead of schedule. The second Phase III study with microplasmin, TG-MV-007, which is recruiting patients in the US and Europe is due to complete enrolment in the first half of 2010 as planned. Enrolment completion in this study means that ThromboGenics is a step closer to becoming a profitable, integrated Company focused on cutting edge ophthalmic medicines.

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 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 125microg 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).

The primary endpoint of both 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. ThromboGenics has used both OCT and ultrasound technology in previous studies evaluating microplasmin in eye disease. Based on this experience and discussions with the FDA, OCT was selected as the main assessment technique for the Phase III program as it provides results which have greater clinical relevance. 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 TG-MV-006 study will be presented by mid 2010.

Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleased to announce that we have completed enrolment of the US pivotal Phase III trial for microplasmin months ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is very encouraging. Today's announcement brings us a step closer to potentially changing the way a number of important eye conditions are treated, as well as bringing us closer to our key aim of becoming a profitable, integrated business focused on cutting edge ophthalmic medicines. We very much look forward to announcing the results of this trial by the middle of next year and I am confident that ThromboGenics will continue to deliver on the milestones needed to build a strong, successful and profitable Company."

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

    Dr. Patrik De Haes, CEO                   Tel: +32-16-75-13-10
                                              patrik.dehaes@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
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. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
9. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
10. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
11. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/7/2017)... 7, 2017  Novavax, Inc., (Nasdaq: NVAX ) ... 2 trials of its RSV F protein recombinant nanoparticle vaccine ... have been published in the journal Vaccine ... in prior scientific conferences). The Company previously announced top ... is developing the RSV F Vaccine with the goal of ...
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq:  NXTM), a ... today announced new findings demonstrating positive biochemical outcomes related ... System One™. The data will be presented at the ... Madrid, Spain . The ... Home Dialysis Network in Europe ...
(Date:5/29/2017)... -- Cellect Biotechnology Ltd. (NASDAQ: APOP ; TASE: APOP), ... selection of stem cells, today provided a corporate update ... March 31 st , 2017. "We ... quarter of 2017," said Dr. Shai Yarkoni, Chief Executive ... of the first blood cancer patient in the recently ...
Breaking Medicine Technology:
(Date:6/25/2017)... ... ... Month and the focus is on prostate cancer. Second only to skin cancer, prostate ... common cause of cancer related death today; lung cancer remains in the number one spot. ... during his lifetime. Those at highest risk are men who have a family ...
(Date:6/24/2017)... ... ... Doorknobs are for convenience, deadbolts are for security. , There are many ... an alarm system installed. But unless there is a working deadbolt lock that is ... Premier Locksmith in Killeen, TX says: “In the majority of home burglaries, intruders use ...
(Date:6/23/2017)... ... June 24, 2017 , ... Studies show evidence that carotenoids and antioxidants derived ... loss in these patients. , But how often do ophthalmologists and optometrists in Sweden ... at risk of or with early symptoms of AMD? A study published recently ...
(Date:6/23/2017)... ... ... Goodcents Deli Fresh Subs today announced the opening of a new restaurant ... Topeka, Kan. 66604 (near 21st and Gage). It is owned and operated by long-time ... in the Topeka and Bonner Springs, Kan. area. , “Goodcents has such a ...
(Date:6/23/2017)... ... June 23, 2017 , ... MD Now Urgent ... is MD Now’s 28th facility overall and marks the urgent care center's eighth location ... mile North of The Falls shopping mall. The new clinic offers a wide array ...
Breaking Medicine News(10 mins):