ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
By Thrombogenics Nv, PRNETuesday, December 15, 2009
MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over 640 patients Ahead of Schedule
LEUVEN, Belgium, December 16 - 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
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
For further information please contact: ThromboGenics: Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes at thrombogenics.com; Dr. Steve Pakola, CMO, Tel: +1-212-201-0920, steve.pakola at thrombogenics.com; Citigate Dewe Rogerson: Amber Bielecka/David Dible/Nina Enegren, Tel: +44(0)207-638-95-71, amber.bielecka at citigatedr.co.uk
Tags: belgium, Leuven, ThromboGenics NV