LEUVEN, Belgium, December 16
- MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over640 patients Ahead of Schedule
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical companyfocused on the discovery and development of innovative treatments for eyedisease, vascular disease and cancer, announces today that it has completedthe enrolment of the second Phase III trial evaluating microplasmin for thenon-surgical treatment of eye disease. The trial TG-MV-007, which recruitedpatients both in Europe and the United States, has completed enrolment ofover 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 SurgicalTreatment) program. This program involves two clinical trials, which aretaking place in the United States (TG-MV-006 trial) and in Europe and theUnited States (TG-MV-007 trial). Both of the MIVI-TRUST trials aremulti-center, randomized, placebo controlled, double-masked trials which areevaluating 125micro g of microplasmin versus placebo in the intravitrealtreatment of patients with focal vitreomacular adhesion.
The initial indication for both of the Phase III microplasmin trials isthe non-surgical treatment of focal vitreomacular adhesion. Focalvitreomacular adhesion is a condition in which the vitreous gel, in thecenter of the eye, has an abnormally strong adhesion to the retina at theback of the eye. Vitreomacular adhesion is thought to play a key role innumerous back of the eye conditions such as macular hole formation, and someforms of macular edema. Vitreomacular adhesion is also associated with a muchpoorer prognosis in certain major eye conditions, including DiabeticRetinopathy and Age-related Macular Degeneration (AMD). ThromboGenicsrecently started a Phase II study evaluating microplasmin in patients withAMD.
The primary endpoint of both of the MIVI-TRUST trials is the non-surgicalresolution of focal vitreomacular adhesion after one month. This anatomicalendpoint is being measured and recorded using Optical Coherence Tomography(OCT) which provides images that can clearly show the separation of thevitreous from the retina. OCT is a very sensitive and specific method fordetecting the resolution of focal vitreomacular adhesion. In addition to theprimary endpoint, the Phase III trials will evaluate additional measures ofefficacy as well as safety, assessed at various time periods over the sixmonth study period.
It is expected that the results from the first microplasmin Phase IIIstudy, the TG-MV-006 study will be presented in Q2 2010 and the results fromthe TG-MV-007 study in Q3 2010.
Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleasedto announce that we have completed enrolment of our second pivotal Phase IIItrial for microplasmin, ahead of schedule. Microplasmin is key to the successof our ophthalmic focused strategy and the speed at which patients have beenrecruited is encouraging. We very much look forward to announcing the firstresults from our MIVI-TRUST Phase III program by mid 2010."
ThromboGenics is a biopharmaceutical company focused on the discovery anddevelopment of innovative medicines for the treatment of eye disease,vascular disease and cancer. The Company's lead product microplasmin is inPhase III clinical development for the non-surgical treatment of back of theeye diseases. Microplasmin is also being evaluated in Phase II clinicaldevelopment for additional vitreoretinal conditions. In addition,ThromboGenics is developing novel antibody therapeutics in collaboration withBioInvent International; these include TB-402 (Anti-Factor VIII), a longacting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven andthe Flanders Institute for Biotechnology (VIB) and has exclusive rights tocertain therapeutics developed at these institutions. ThromboGenics isheadquartered in Leuven, Belgium. The Company is listed on Eurolist byEuronext Brussels under the symbol THR. More information is available athttp://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 currentexpectations, and, accordingly, entail and are influenced by various risksand uncertainties. The Company therefore cannot provide any assurance thatsuch forward-looking statements will materialize and does not assume anobligation to update or revise any forward-looking statement, whether as aresult of new information, future events or any other reason. Additionalinformation concerning risks and uncertainties affecting the business andother factors that could cause actual results to differ materially from anyforward-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 email@example.com Dr. Steve Pakola, CMO Tel: +1-212-201-0920 firstname.lastname@example.org Citigate Dewe Rogerson Amber Bielecka/David Dible/Nina Enegren Tel: +44(0)207-638-95-71 email@example.com
SOURCE ThromboGenics NV