ThromboGenics Announces Results From a Phase IIa Trial Evaluating Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
LEUVEN,
– Data Presented at the American Society of Retina Specialists (ASRS)
Conference in
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company
focused on the discovery and development of innovative medicines for eye
disease, vascular disease and cancer, today announces results of a Phase IIa
trial evaluating microplasmin intravitreal injection for the treatment of
Diabetic Macular Edema (MIVI II DME). The data from this trial were presented
at the ASRS (American Society of Retina Specialists) Conference in
on
The MIVI II DME trial was designed to be the initial step in evaluating
microplasmin in patients with diabetes, a group which is more prone to eye
disease, and specifically diabetic retinopathy. Diabetic retinopathy is a
major cause of visual loss and the leading cause of blindness in patients
aged 20-60. Previous studies in this advanced patient population have shown
that, given the underlying condition, the adhesion between the vitreous and
retina tends to be much stronger, as evidenced during vitrectomy. This level
of adhesion makes it more challenging to achieve a total PVD in patients with
advanced DME, as opposed to earlier stage diabetic retinopathy.
The MIVI II DME trial was a Phase IIa, randomized, double masked, sham
injection controlled, dose ascending clinical trial evaluating the safety and
initial efficacy of intravitreal microplasmin (25, 75 and 125 micro g) for
the treatment of patients with Diabetic Macular Edema, a particular form of
diabetic retinopathy. The efficacy endpoint was the induction of posterior
vitreous detachment (PVD), as assessed by the principal investigator (PI) and
the Central Reading Center (CRC) based on ultrasonography. The trial
recruited 51 patients across
advanced DME, as evidenced by prior laser treatment in 46% of the sham
patients and 76% of the microplasmin-treated patients.
The data showed that microplasmin was safe and well tolerated. The
principal investigators found that within three days after microplasmin
injection, a total PVD in two out of 15 patients was observed in the 125ug
dose group, and by day 28, two additional patients out of 15 in the 75 ug
dose group had total PVD. The investigators did not observe total PVD by day
28 in any patients who received 25 micro g of microplasmin or the sham
injection. The PI results were regarded as giving the most accurate view of
microplasmin’s efficacy in this study, due to inherent limitations in the CRC
assessment,
Professor
this trial are encouraging and show that microplasmin is able to
non-surgically induce release of vitreomacular adhesion in some DME patients.
Moreover, the fact that we have been able to show some evidence of biologic
activity with the higher doses of microplasmin in patients with such advanced
DME demonstrates microplasmin’s potential in the wider diabetic retinopathy
population. This combined with the excellent safety suggests that further
studies are warranted in diabetic patients.”
Dr
starting point in assessing the utility of microplasmin treatment of diabetic
retinopathy. We will finalise the next step in the development plan for
microplasmin in this patient population once we have the results from the
first Phase III trial (TG-MV-006), which are anticipated by mid-2010. The
results from this 326 patient trial will provide us with a significant amount
of additional data that will help us to refine our development plans for
microplasmin in patients with diabetic retinopathy.”
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,
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