Microplasmin Meets Primary Endpoint in Second Phase III Trial in VMA, Confirms Positive Findings of First Trial
LEUVEN, Belgium, September 1, 2010/PRNewswire-FirstCall/
--
- Data Presented at ASRS Confirm Previous Phase III Findings and
Microplasmin's Potential to Transform the Treatment of Retinal
Disorders
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative
treatments for eye disease, vascular disease and cancer announces
that its second Phase III trial evaluating microplasmin for the
non-surgical treatment of vitreomacular adhesion (VMA) has met its
primary endpoint. Importantly, the trial also confirmed the
positive results seen in the first Phase III trial with
microplasmin. The results of the second Phase III trial (TG-MV-007)
were presented for the first time at the American Society of Retina
Specialists (ASRS) Annual Meeting by Dr. J. Michael Jumper (West
Coast Retina and Medical Group and California Pacific Medical
Center, California, USA). The trial recruited 326 patients at 48
centers in Europe and the U.S.
The detailed positive results from the first Phase III trial in
the microplasmin MIVI-TRUST program (TG-MV-006) were presented at
the World Ophthalmology Congress in Berlin in June 2010. The pooled
results of both trials will be presented at the upcoming EURETINA
(European Society of Retina Specialists) Congress in Paris, France,
on September 4 by Prof. Peter Stalmans (University Hospitals
Leuven, Belgium).
In his presentation at ASRS, Dr. Jumper highlighted that the
TG-MV-007 study had met its primary endpoint, with 25.3% of the 245
microplasmin treated patients achieving resolution of their VMA at
28 days, compared to 6.2% of the 81 patients who received a placebo
injection, a highly statistically significant result (p=0.001). In
patients without epiretinal membrane, microplasmin was shown to be
even more effective with 34.5% of patients seeing resolution of
their VMA at 28 days, compared to 6.4% of placebo treated patients.
Epiretinal membrane is a layer of scar tissue which builds up on
the macula, making it more difficult to achieve resolution of VMA
without surgical intervention. Epiretinal membrane can be easily
identified using Optical Coherence Tomography (OCT).
The TG-MV-007 trial also showed that microplasmin was highly
effective in treating patients who had been diagnosed with full
thickness macular hole (FTMH). In this group, 36.7% of the 49
patients saw closure of their FTMH at 28 days following a single
125g micro injection of microplasmin, without the need for a
vitrectomy. This compares with 6.7% of the 15 patients in the
placebo group (p= 0.028). These positive results are in line with
what was achieved in this patient group in the TG-MV-006
study.
The TG-MV-007 study also evaluated the visual acuity (VA) of
patients. This analysis showed that at the end of the study 22.0%
of the microplasmin treated patients had achieved at least a 10
letter (2 lines) improvement in VA without the need for vitrectomy.
This compares to only 11.1% of the patients who received a placebo
injection (p<0.05). Within the microplasmin treated population,
9% of patients achieved a 15 letter (3 lines) improvement in their
visual acuity without the need for vitrectomy, a level of
nonsurgical improvement that was not seen in any of the patients
who received placebo (p<0.005). In addition, microplasmin
treated patients showed an improved Quality of Life when compared
to placebo, based on the VFQ-25 (National Eye Institute Visual
Functioning Questionnaire) results.
The TG-MV-007 study confirmed that microplasmin was generally
safe and well tolerated. Importantly, consistent with the findings
of the TG-MV-006, there was no evidence of an increased risk of
retinal tear or detachment.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "I am very
pleased that the results from the TG-MV-007 study announced
yesterday have confirmed the positive findings of the first Phase
III trial and clearly show microplasmin's potential to make a
significant impact on the treatment of vitreoretinal disorders.
Over the next several months, key investigators who participated in
the studies will be presenting the exciting data from the overall
MIVI-TRUST program to the global retina community at a number of
major international ophthalmology congresses. Given the success of
the overall Phase III clinical program, I am extremely confident
that microplasmin has the potential to provide both patients and
retina specialists with a highly attractive treatment option for a
broad range of retinal disorders."
Dr. J. Michael Jumper, commenting on his presentation at the
ASRS, said, "These results confirm microplasmin's potential to
treat patients with macular disease caused by vitreous traction,
including full thickness macular hole (a condition which currently
requires major eye surgery to prevent irreversible vision loss),
with a single intravitreal injection, a very appealing option when
compared to surgery."
16th Annual Gertrude D. Pyron Award for Outstanding Achievement
in Retina Research
Dr. Julia Haller (Ophthalmologist-in-Chief, Wills Eye Institute,
and Professor and Chair of Department of Ophthalmology of Thomas
Jefferson University, Philadelphia), was presented with the 16th
Annual Gertrude D. Pyron Award for Outstanding Achievement in
Retina Research at ASRS. At the meeting, she chose to discuss
microplasmin as a treatment option for retinal diseases in the
Pyron Lecture entitled, "Ties That Bind: The Vitreo-Retinal
Relationship." The lecture, which took place on August 29, centered
on the positive results of the microplasmin Phase III program, with
particular focus on the wealth of new information about the
vitreoretinal interface that the MIVI-TRUST program has generated
and its implications for the vitreoretinal surgeon.
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 plays 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 worse
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 remove the vitreous from the eye,
macular hole can lead to irreversible, central blindness. While
vitrectomy is generally effective in closing macular holes, it is
an invasive procedure 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 an
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 a single dose of 125g micro microplasmin versus placebo
in the intravitreal treatment of patients with symptomatic focal
vitreomacular adhesion (VMA). 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
assessed using optical coherence tomography (OCT). 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.
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 has completed two Phase III clinical trials
for the non-surgical treatment of retinal disorders. 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 Ib/II 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: September 2010
