Bli medlem
Bli medlem

Du är här


ThromboGenics NV: ThromboGenics Enrolls First Patient in Phase II CIRCLE Trial

ThromboGenics Enrolls First Patient in Phase II CIRCLE Trial Evaluating

Multiple Doses of Ocriplasmin to induce a Total Posterior Vitreous Detachment
in Patients with Non-Proliferative Diabetic Retinopathy (NPDR)

Assessing the potential of ocriplasmin to reduce risk of disease progression
from NPDR to sight-threatening Proliferative Diabetic Retinopathy (PDR)

Leuven, January 13, 2016
- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical
company focused on developing and commercializing innovative treatments for
diabetic eye disease, today announces that the first patient has been
enrolled in its Phase II CIRCLE study evaluating the efficacy and safety of
multiple doses of ocriplasmin in inducing total posterior vitreous detachment
(PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
ThromboGenics hopes to be able to reduce the risk of disease progression to
proliferative diabetic retinopathy (PDR) by inducing a total PVD using
ocriplasmin. PDR is the major cause of blindness in patients with diabetes.
Patients who progress to PDR are at high risk of experiencing severe vision
loss or complete blindness.

The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled,
multi-center study that will evaluate the efficacy and safety of up to 3
intravitreal injections of either 0.125mg or 0.0625mg of ocriplasmin in
subjects with moderately severe to very severe NPDR, to induce total PVD in
order to reduce the risk of the patient developing sight-threatening PDR.

A total of 230 subjects will be recruited into the CIRCLE trial, approximately
92 in each ocriplasmin arm (0.125mg or 0.0625mg) and 46 in the sham arm, over
the next 12 months. Patients will be accrued from sites across the US, Canada
and EMEA.

The primary endpoint of the CIRCLE study is the percentage of patients with
total PVD by the month 3 visit, confirmed by both B-scan ultrasound and

The study has a number of exploratory secondary endpoints that are designed to
provide further insight into ocriplasmin's potential in reducing the risk of
progression of NPDR to PDR.

For each patient recruited, the CIRCLE study duration will be approximately 24
months from the first injection. The first results are anticipated to be
available in the second half of 2017.

Research has suggested that total PVD, a complete separation of vitreous and
retina, could prevent the progression of NPDR to PDR. This could be explained
by total PVD leading to elimination of the scaffold needed for the
development of new blood vessels and/or the improvement of oxygen supply to
the retina, thereby reducing retinal ischemia, production of VEGF, vascular
outgrowth and neovascularization.

Diabetic retinopathy (DR) is the leading cause of visual disability and
blindness among professionally active adults[1]. Worldwide, the prevalence
rate of vision-threatening PDR or diabetic macular edema (DME) was estimated
to be 11.72% of the diabetic population in 2010[2].

A recent report from the American Academy of Ophthalmology has projected that
the prevalence of individuals with any form of diabetic retinopathy in the
United States in the year 2020 will be 6 million people, of whom 1.34 million
persons will have vision-threatening DR[3](PDR or diabetic macular edema

David Scales, MD - Principal Investigator at Foreseight Studies, LLC in San
Antonio, Texas, USA for the Circle Study
said, "I am delighted that we have recruited the first patient in this
study. There is a clear medical need for a treatment option that is able to
prevent patients with NPDR progressing to PDR, a disease state that could
result in them losing their sight. Achieving this, by using up to 3 doses of
ocriplasmin to generate a total PVD pharmacologically, would be a major
advance in the overall treatment of diabetic retinopathy."

Dr Patrik De Haes, CEO of ThromboGenics,
commenting on today's announcement, "The start of the CIRCLE study is a major
milestone for ThromboGenics as we focus our research efforts on delivering
important advances in the treatment of diabetic eye disease. The CIRCLE trial
is designed to show that multiple doses of either 0.125mg or 0.0625mg of
ocriplasmin can generate total PVD in patients with NPDR.
We hope that by using ocriplasmin to generate PVD, we can prevent a
significant number of patients with NPDR experiencing their disease
progressing to PDR, which could potentially lead to them losing their sight."


For further information please contact:

| ThromboGenics Citigate Dewe Rogerson |
| |
| |
| David Dible/Sylvie Berrebi |
| Tel: +44 20 7282 2867 |
|Wouter Piepers, |
|Global Head of Corporate Communications&IR |
|+32 16 75 13 10 / +32 478 33 56 32 |
| |
About Diabetic Retinopathy

According to the World Health Organization (WHO), in 2014, 9% of adults 18
years and older had diabetes (WHO, 2015)[4].

Diabetic retinopathy (DR) is the leading cause of visual disability and
blindness among professionally active adults (Cunha-Vaz, 1998; Fong et al.,
1999). Worldwide, the prevalence rate of vision-threatening PDR or DME was
estimated to be 11.72% of the diabetic population in 2010 (Yau et al., 2012).

DR progresses from mild, non-proliferative to more severe, or even
proliferative stages. As DR progresses, there is a gradual closure of retinal
vessels leading to impaired perfusion and retinal ischemia. When this
progresses beyond certain thresholds, severe non-proliferative diabetic
retinopathy (NPDR) is diagnosed.

The more advanced stage, PDR, is characterized by the development of new blood
vessels at the inner surface of the retina as a result of retinal ischemia.
These new vessels are prone to bleed, resulting in vitreous hemorrhage. These
new vessels may also undergo fibrosis and contraction, which may lead to
epiretinal membrane formation, vitreoretinal traction bands, retinal tears
and traction or retinal detachments.

PDR is considered high risk when the new vessels are accompanied by vitreous
hemorrhage, or when they cover a significant area of the optic disc, even in
the absence of vitreous hemorrhage, Patients with high risk PDR are at high
risk of severe vision loss. The current treatment standard for PDR patients
is laser photocoagulation (PRP) therapy. Lately, an increasing role for
anti-VEGF treatments has also been demonstrated.

PDR patients may still progress to severe vision loss or even complete vision
loss resulting from persistent or recurrent disease, even when receiving
recurrent pan-retinal photocoagulation (PRP). In addition, recurrent
treatment with PRP may lead to complications such as visual field loss or
worsening of macular edema.[5][6]

About ThromboGenics

ThromboGenics is an integrated biopharmaceutical company focused on developing
and commercializing innovative treatments for diabetic eye disease.

The Company's first product, JETREA® (ocriplasmin), has been approved in 53
countries across the globe. In the US, ThromboGenics is commercializing
JETREA® via its subsidiary ThromboGenics, Inc. ThromboGenics signed an
agreement with Alcon, a division of Novartis, for the commercialization of
JETREA® outside the United States.

ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial to
assess ocriplasmin as a potential treatment for diabetic retinopathy In
addition the Company is evaluating several other drug candidates that could
potentially deliver a number of next generation treatments for diabetic eye

ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin,
NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext
Brussels exchange under the symbol THR.

More information is available

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.
This press release does not constitute an offer or invitation for the sale or
purchase of securities or assets of ThromboGenics in any jurisdiction. No
securities of ThromboGenics may be offered or sold within the United States
without registration under the U.S. Securities Act of 1933, as amended, or in
compliance with an exemption therefrom, and in accordance with any applicable
U.S. state securities laws.
---------------------------------------[1]Cunha-Vaz J (1998). Lowering the risk of visual impairment and
blindness.Diabet Med.
15 (Suppl 4): S47-50.
[2]Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ,
Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T,
Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta
M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ,
Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis
for Eye Disease (META-EYE) Study Group (2012). Global prevalence and major
risk factors of diabetic retinopathy.Diabetes Care
35 (3): 556-564.
[4]World Health Organization (WHO). (2015). Diabetes. Fact sheet N°312. 21 May 2015.
[5]Bailey CC, Sparrow JM, Grey RH, Cheng H (1999). The National Diabetic
Retinopathy Laser Treatment Audit. III. Clinical outcomes.Eye (Lond)
13 (Pt 2): 151-159.
[6]Fong DS, Ferris FL 3rd, Davis MD, Chew EY (1999). Causes of severe visual
loss in the early treatment diabetic retinopathy study: ETDRS report no. 24.
Early Treatment Diabetic Retinopathy Study Research Group.Am J Ophthalmol.

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.