ThromboGenics Presents Positive Pooled Results from the MIVI-TRUST Phase III Program, Confirming Microplasmin's Potential to Transform the Treatment of Retinal Disorders
LEUVEN, Belgium, September 6, 2010/PRNewswire-FirstCall/
--
- Data Presented at EURETINA Highlight the Attractive
Characteristics of this Novel Potential Treatment Option for
Retinal Disorders
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical
company focused on the discovery and development of innovative
treatments for eye disease, cardiovascular disease and cancer,
announces that the pooled results from the successful microplasmin
MIVI-TRUST Phase III program were presented today at the EURETINA
(European Society of Retina Specialists) Congress in Paris, France.
The MIVI-TRUST program is the largest interventional clinical
program ever performed to specifically evaluate the vitreoretinal
interface in patients with retinal disorders, recruiting a total of
652 patients at 90 centers across the U.S. and Europe.
The pooled results of the TG-MV-006 and TG-MV-007 Phase III
trials were presented by Prof. Peter Stalmans (University Hospitals
Leuven, Belgium). These results demonstrate the potential of
microplasmin to transform the treatment of a range of retinal
disorders.
The Phase III program showed that microplasmin:
- Was successful in resolving vitreomacular adhesion (VMA)
- Was able to cure full thickness macular hole (FTMH) without the
need for surgery
- Delivered an improvement in the vision of patients without the
need for surgery
- Was safe and well tolerated
Both the TG-MV-006 and TG-MV-007 trials met the primary
endpoint, achieving a statistically significant improvement in the
resolution of VMA. The pooled results from the MIVI-TRUST program
showed that 26.4% of the 465 microplasmin treated patients achieved
resolution of their VMA at 28 days, compared to 10.2% of the 182
patients who received a placebo injection, a highly statistically
significant result (p=0.000002).
In patients without epiretinal membrane, microplasmin was shown
to be even more effective, with 37.4% of 270 patients achieving
nonsurgical resolution of their VMA at 28 days, compared to 14.3%
of 119 placebo treated patients (p=0.000003). 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 MIVI-TRUST program's pooled results also highlighted
microplasmin's impressive effect in patients diagnosed with FTMH.
In this group, 40.6% of the 106 patients saw closure of their FTMH
at 28 days following a single 125micro-g injection of microplasmin
without the need for a vitrectomy. This compares with 10.6% of the
47 patients in the placebo group (p= 0.00015). The closure of FTMH
also led to microplasmin treated patients experiencing a
significant improvement in their visual acuity (VA) compared to
baseline.
Prof. Stalmans also presented an analysis of the pooled visual
acuity data from the Phase III program. This showed that at the end
of the six month study period, 23.7% 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 11.2% of
the patients who received a placebo injection (p=0.0002). Within
the microplasmin treated population, 9.7% of patients achieved a 15
letter (3 lines) improvement in their visual acuity without the
need for vitrectomy, compared to just 3.7% of the placebo patients
(p=0.01). In addition, microplasmin treated patients showed an
improved Quality of Life when compared to placebo, based on the
VFQ-25 (the National Eye Institute Visual Functioning
Questionnaire) results.
The pooled results also confirmed that microplasmin was
generally safe and well tolerated. There was no evidence of an
increased risk of retinal tear or detachment.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The
successful completion and reporting of our 652 patient Phase III
program with microplasmin in just 20 months demonstrates
ThromboGenics' highly effective drug development capabilities. The
pooled data presented today clearly show that microplasmin could
make a significant difference to the treatment of vitreoretinal
disorders. The results from these pivotal trials will form the
central part of the packages that we plan to submit to the FDA and
EMA by mid 2011 to support our applications for marketing approval.
Given the success of the overall Phase III clinical program and our
plans to market microplasmin ourselves both in the U.S. and Europe,
we are now gearing up our pre-marketing activities and our
commercial organization. Based on these exciting results and our
discussions with many leading retinal specialists, I am convinced
that microplasmin has the potential to become a highly attractive
treatment option for a broad range of retinal disorders."
Prof. Peter Stalmans, commenting on his presentation at
EURETINA, said, "I am delighted to have presented these pooled
results for the first time. Based on these exciting Phase III
results and my own personal experience, I have little doubt that
microplasmin will quickly become an important treatment option for
patients with a range of retinal disorders, including macular hole.
The benefits of this simple one-off injection are very appealing,
when compared to surgery, to both patients and retina
specialists."
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 125μg 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
