ThromboGenics Presents New Exciting Microplasmin Phase III Data at the World Ophthalmology Congress (WOC) in Berlin
LEUVEN, Belgium, June 7, 2010/PRNewswire-FirstCall/ --
- Data Presented Show Microplasmin Cures Approximately 50% of
Patients With Macular Hole
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 April.
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 Degeneration
(AMD).
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.
About ThromboGenics
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
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
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
Posted: June 2010
