ThromboGenics Announces that Microplasmin Meets Primary Endpoint in Phase III Trial for the Non-Surgical Treatment of Symptomatic Vitreomacular Adhesion (VMA)
By Thrombogenics Nv, PRNEMonday, April 19, 2010
Highly Significant Trial Result (p=0.003) Demonstrates the Potential of Microplasmin in the Treatment of Retinal Disease
LEUVEN, Belgium, April 20, 2010 - 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 that its first Phase III
trial with microplasmin for the non-surgical treatment of eye disease has met
its primary endpoint (p=0.003). The trial, TG-MV-006, recruited a total of
326 patients in the U.S. A second Phase III study with microplasmin,
TG-MV-007, which recruited a similar number of patients in the U.S. and
Europe, is due to report in the third quarter of 2010.
The microplasmin Phase III program, referred to as MIVI-TRUST
(Microplasmin for IntraVitreous Injection-Traction Release without Surgical
Treatment), consists of two multi-center, randomized, placebo controlled,
double-masked trials. These trials are designed to evaluate 125μg of
microplasmin versus placebo in the intravitreal treatment of patients with
symptomatic focal vitreomacular adhesion (VMA). The MIVI-TRUST program is the
largest interventional clinical program ever performed to specifically
evaluate the vitreoretinal interface in patients with retinal disorders.
The primary endpoint of both trials is the non-surgical
resolution of focal vitreomacular adhesion one month after a single injection
of microplasmin. This endpoint is being measured and recorded using optical
coherence tomography (OCT), the standard method of assessment for this
condition, which provides images that can clearly show the separation of the
vitreous from the retina.
The results of the first trial, TG-MV-006, confirmed that it
had met its primary endpoint with 27.7% of microplasmin treated patients
achieving resolution of their VMA compared to 13.2% of patients treated with
placebo injection (p=0.003). A Per Protocol analysis of the microplasmin
treated patient population showed that 30.7% achieved resolution of their VMA
(p=0.004).
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. These data will be
presented at the World Ophthalmology Congress (WOC) in Berlin by Dr. Matthew
Benz, MD (Baylor College of Medicine, Houston, Texas, U.S.).
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "This is
the most important milestone in ThromboGenics' history. Microplasmin is key
to the success of our ophthalmic focused strategy, and we are very pleased to
be able to announce these positive results. The fact that microplasmin
resolved VMA without surgery in approximately 30% of patients is a clinically
important development. These results reaffirm our confidence in the potential
of this innovative approach to the treatment of a range of retinal disorders.
We are moving ahead with our pre-commercialization activities for
microplasmin, so that we are well-positioned to launch this unique product
successfully."
About Focal Vitreomacular Adhesion (VMA)
Focal vitreomacular adhesion is a condition in which the
vitreous gel, in the center of the eye, has an abnormally strong adhesion to
the macula, the center of 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 and some forms of macular edema.
Vitreomacular adhesion is also associated with a poorer prognosis in certain
major eye conditions, including Diabetic Retinopathy and Age-related Macular
Degeneration (AMD).
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
has completed its first Phase III clinical trial 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 in Phase II, and TB-403 (anti-PlGF) in
Phase I for cancer.
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:
ThromboGenic 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
For further information please contact: ThromboGenic, Dr. Steve Pakola, CMO, Tel: +1(212)201-0920, steve.pakola at thrombogenics.com ; Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes 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: April 20, belgium, Leuven, ThromboGenics NV