PRNewswire
Trial Results Expected Mid-2008
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on vascular diseases, eye diseases and cancer, today announces that
it has completed patient enrolment for its Phase IIb MIVI III trial in the
United States. This study is designed to evaluate the safety and efficacy
of Microplasmin in vitrectomy (MIVI III - Microplasmin for Vitreous
Injection).
A vitrectomy is a surgical procedure carried out in the treatment of
many back of the eye diseases such as retinal detachment, diabectic
vitreous hemorrhage and macular hole. Vitrectomy is used to induce a
posterior vitreous detachment (PVD) which involves removing the vitreous
via suction. Microplasmin is a proteolytic enzyme that cleaves important
molecules which link the vitreous to the retina and therefore has the
potential to facilitate vitrectomy and induce PVD without the risks
inherent in detachment by surgical intervention.
MIVI III is a Phase IIb, randomized, double-masked, placebo-controlled,
dose-ranging trial evaluating three doses of Microplasmin (25, 75 and 125
μg) versus placebo in 120 patients scheduled for vitrectomy. The trial
is taking place across 19 sites throughout the United States and is
assessing the safety and efficacy of Microplasmin intravitreal injection 7
days prior to vitrectomy. Top-line, unmasked results of this trial are
expected in June 2008.
Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on
today's announcement, said: "We are very pleased to have completed
enrolment in our lead program. Microplasmin has the potential to
significantly change the way we treat back of the eye diseases and this
study will bring us a step closer to realising this potential. Due to
encouraging safety and efficacy results obtained from both the MIVI I and
MIVI II Traction Phase II trials which were conducted in Europe, we are
confident that we will have further encouraging results from this trial."
About Vitrectomy
Approximately 600,000 surgical vitrectomies are performed annually
worldwide. The U.S. market accounts for more than 40% of treatments, and is
growing at 6-8% per year. During a vitrectomy, three incisions are made
through the white of the eye; the surgeon then inserts small instruments
into the eye, cuts the vitreous gel, and suctions it out. There are certain
risks inherent to this surgery including bleeding, infection, increased eye
pressure, retinal detachment, and development of cataracts.
As Microplasmin could induce a PVD without the need for vitrectomy, it
may serve as a more convenient, less invasive treatment option for certain
eye conditions. For example, results from ThromboGenics' MIVI II Traction
trial, which examined the safety and efficacy of Microplasmin in the
treatment of vitreomacular traction showed that Microplasmin was able to
resolve vitreomacular traction and even achieve closure of some macular
holes, conditions that otherwise would have required vitrectomy.
Other major eye diseases that may benefit from nonsurgical PVD
induction include diabetic retinopathy and age-related macular degeneration
(AMD). Diabetic retinopathy is the leading cause of blindness among
working-age adults, while AMD is the leading cause of blindness among the
elderly.
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery and
development of biopharmaceuticals for the treatment of a range of vascular
diseases. The Company has several programs in Phase II clinical development
including microplasmin, which is being evaluated as a treatment for
vitreoretinal disorders and as a thrombolytic agent for vascular occlusive
diseases such as acute stroke. ThromboGenics is also developing novel
antibody therapeutics in collaboration with BioInvent International; these
include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical
development in late 2008, and TB-403 (Anti-PlGF), which has begun Phase I
clinical trials for the treatment of cancer. ThromboGenics has built strong
links with the University of Leuven and has exclusive rights to certain
therapeutics developed at the University. ThromboGenics is headquartered in
Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S.
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 prospectus.