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Last updated on May 28, 2012 at 21:34 EDT

ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)

March 6, 2009
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LEUVEN, Belgium, March 6 /PRNewswire-FirstCall/ — ThromboGenics NV
(Euronext Brussels: THR), a biotechnology company focused on innovative
treatments for eye disease, vascular disease and cancer, today announces that
it has completed patient enrolment for a Phase II trial of microplasmin
intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II
DME). This trial is designed as the initial step in evaluating the utility of
microplasmin in patients with diabetes, a group which is more prone to eye
disease such as diabetic retinopathy, due to their underlying medical
condition.

The MIVI II DME trial is a Phase II, randomized, double masked, sham
injection controlled, dose ascending clinical trial evaluating the safety and
initial efficacy of intravitreal microplasmin for the treatment of patients
with Diabetic Macular Edema, a particular form of diabetic retinopathy. The
trial is primarily intended to evaluate safety in this specific patient
population, but will also assess efficacy by measuring the induction of
posterior vitreous detachment (PVD). The trial recruited over 50 patients
across Europe. Patients are to be followed for 12 months, with first unmasked
data analyzed after 6 months follow-up, and to be presented towards the end
of 2009.

Diabetic retinopathy is a major cause of visual loss and the leading
cause of blindness in patients aged 20-60. Diabetic Macular Edema (DME) is a
condition where swelling of the retina occurs in patients with diabetic
retinopathy, due to a leakage of fluid from blood vessels within the macula.
The only approved treatment for patients with DME is laser photocoagulation;
however, this treatment does not improve vision once it is lost. In patients
who do not respond to laser photocoagulation, vitrectomy (the surgical
procedure used to produce a PVD) is currently used as a treatment, as
vitreomacular adhesion is thought to play an important part in the disease.

The Company believes that microplasmin may represent a major advance in
this area, as detaching the vitreous from the retina has been associated with
greatly reducing the growth of new blood vessels (neovascularization) on the
retina, which plays a fundamental role in the loss of vision in many diabetic
patients.

Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commented, “We
are very pleased to announce the completion of enrolment in MIVI II DME. This
initial study is an important first step in evaluating microplasmin’s effect
in the diabetic retinopathy population in general. Microplasmin could
represent an important treatment option for this patient population, given
numerous studies from various groups showing the clinical benefits of
vitreous detachment in diabetic retinopathy.”

About ThromboGenics

ThromboGenics is a biotechnology company focused on the discovery and
development of biopharmaceuticals 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 and as a potential
therapy for stroke. ThromboGenics is also 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


Source: newswire