ThromboGenics Presents New Exciting Microplasmin Phase III Data at the World Ophthalmology Congress (WOC) in BerlinBy Thrombogenics Nv, PRNE
Sunday, June 6, 2010
Data Presented Show Microplasmin Cures Approximately 50% of Patients With Macular Hole
LEUVEN, Belgium, June 7, 2010 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative treatments for
eye disease, announces that further data from the first successful Phase III
trial with microplasmin (TG-MV-006) for the non-surgical treatment of
vitreomacular adhesion (VMA) were presented at the World Ophthalmology
Congress by Dr. Matthew Benz, MD (The Methodist Hospital, Houston, Texas,
U.S.) The trial recruited 326 patients at 42 centers in the U.S. The second
Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-007) is due to
report in the third quarter of 2010.
In his presentation, Dr. Benz highlighted that the TG-MV-006
study had met its primary endpoint with 27.7% of the 220 microplasmin treated
patients achieving resolution of their VMA at 1 month, compared to 13.2% of
the 106 patients who received a placebo injection, a highly statistically
significant result (p=0.003). He also presented data on a Per Protocol
analysis of the microplasmin treated patient population, all of whom met the
study's inclusion criteria, that showed that 30.7% achieved resolution of
their VMA (p=0.004). These top-line results had previously been announced in
The trial evaluated the visual acuity (VA) of patients. This
analysis showed that at the end of the study 25.5% of the microplasmin
treated patients had achieved at least a 10 letter improvement in VA without
the need for vitrectomy. This compares to only 11.3% of the patients who
received a placebo injection (p<0.005).
The TG-MV-006 study also confirmed that microplasmin was
generally safe and well tolerated with no increase in the rate of retinal
tear or detachment in comparison to placebo.
A key finding from the TG-MV-006 study that was presented in
Berlin related to patients who had been diagnosed with full thickness macular
hole (FTMH), a severe condition which can lead to irreversible vision
impairment, including central blindness, if not treated by eye surgery
(vitrectomy). In this group, 45.6% of the 52 patients were cured by a single
125 micro g injection of microplasmin without the need for a vitrectomy in
the 6 months post treatment. This compares with 15.6% of the 32 patients in
the placebo group (p= 0.005). A Per Protocol analysis of the microplasmin
treated patients showed that 54.3% of patients achieved FTMH closure after 6
months without the need for surgery.
The closure of FTMH also resulted in these patients
experiencing a significant improvement in their VA compared to baseline.
These results show that microplasmin could represent a major breakthrough, as
it has the potential to cure approximately 50% of patients with FTMH without
the need for major eye surgery.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The more
detailed results from the TG-MV-006 study that we have announced today
clearly show that microplasmin has the potential to make a significant impact
on the treatment of retinal disorders linked to adhesion. In addition, I am
particularly excited that we have shown that microplasmin has the ability to
cure approximately 50% of patients with macular hole, a very severe condition
which can lead to central blindness. Given these results, I am confident that
microplasmin could provide both patients and retinal specialists with an
alternative to surgery. We are looking forward to announcing the results from
our second Phase III study with microplasmin, which is due to report in the
third quarter of 2010."
Dr. Matthew Benz, commenting on his presentation today, said,
"I am sure that the results of this important study, which is part of the
largest interventional clinical program ever performed to specifically
evaluate the vitreoretinal interface, will create great excitement in the
retinal community. The ability to cure a significant proportion of patients
with a range of retinal disorders, including macular hole, with a simple
injection of microplasmin is clearly an attractive alternative to the current
option of surgery."
Notes to Editors
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
About Macular Hole
Focal vitreomacular adhesion can lead to macular hole, where
the traction from the vitreomacular adhesion actually pulls off a piece of
the macula (the part of the retina responsible for central vision). If not
treated with major eye surgery called a vitrectomy, which involves using
suction to completely remove the vitreous from the eye, macular hole can lead
to irreversible, central blindness. While vitrectomy is generally effective
in closing macular holes, the invasive procedure is costly and a proportion
of patients experience side-effects. These include alteration of vision,
bleeding, retinal detachment and development of glaucoma and cataracts.
Therefore, a nonsurgical treatment option for such patients could be a very
important breakthrough in the way macular hole patients are treated.
The MIVI-TRUST Program
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 125 micro g 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. In
total, over 650 patients were enrolled in these trials, which were held
across 90 centers in 7 countries.
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.
ThromboGenics is a biopharmaceutical company focused on the
discovery and development of innovative medicines for the treatment of eye
disease. 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 in partnership with Roche.
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. Steve Pakola, CMO Tel: +1(212)201-0920 firstname.lastname@example.org Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 email@example.com Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71 firstname.lastname@example.org
For further information please contact: ThromboGenics, 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
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