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ThromboGenics Enrolls First Patients in Phase II Clinical Study Evaluating THR-317 (Anti-PlGF) for Diabetic Macular Edema (DME)

Dienstag, 10.01.2017 07:35 von

PR Newswire

LEUVEN, Belgium, January 10, 2017 /PRNewswire/ --

THR-317 could become an attractive alternative or add-on treatment for current anti-VEGF medicines when treating DME or DR  

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company, focused on developing novel medicines for diabetic eye disease, announces the enrollment of the first patients in a Phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular edema (DME).

THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).

The Phase II study will evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME.

Recent preclinical data evaluating THR-317 (using a research grade anti-PlGF antibody) have confirmed a number of potential advantages of an anti-PlGF antibody for the treatment of DR when compared to the current standard of care. Therefore, ThromboGenics believes that THR-317 could be used as a stand-alone therapy or as an add-on treatment to anti-VEGF medicines, for the treatment of DME or DR

The study plans to enroll a total of 50 patients over a period of about 12 months. The first results from the study are expected in Q1 2018.

Dr Patrik De Haes, CEO of ThromboGenics nv, said, "Knowing that 35% of all diabetes patients will in their lives develop some form of diabetic retinopathy (DR), there is a clear unmet medical need and an increasing demand for improved or add-on treatment options. We believe that our anti-PlGF antibody THR-317 holds the potential to differentiate and improve current standard of care for this important sight-threatening disease. We are very pleased to see the first patients being recruited."

Dr András Seres, Ophthalmologist and Director at/of Budapest Retina Associates comments, "The pre-clinical data I have seen highlight this anti-PlGF antibody's potential advantages over the current standard of care in DR. With clinicians and patients in need of additional safe and effective therapies for the treatment of DR, these data provide strong rationale for taking the compound into the clinic."

ThromboGenics plans on evaluating THR-317 in additional DR indications if the current Phase II trial delivers positive results.


For further information please contact: 


   
    ThromboGenics                                  Citigate Dewe Rogerson

    Wouter Piepers,                                David Dible/Sylvie Berrebi
    Global Head of Corporate Communications & IR   Tel: +44 20 7282 9571
    +32 16 75 13 10 / +32 478 33 56 32             david.dible@citigatedr.co.uk
    wouter.piepers@thrombogenics.com               sylvie.berrebi@citigatedr.co.uk


About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.

ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR).

Early 2017, ThromboGenics enrolled its first patient in a Phase II clinical study evaluating THR-317, a PIGF inhibitor for the treatment of diabetic macular edema, as a stand-alone or as a combination therapy with anti-VEGF treatments.

In addition, THR-149, a plasma kallikrein inhibitor, which has resulted from research collaboration with Bicycle Therapeutics, and THR-687, an integrin antagonist, which was in-licensed from Galapagos, are in late stage pre-clinical development.

ThromboGenics pioneered a new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in 54 countries worldwide. ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. in the US. Novartis commercializes JETREA® outside the United States.

ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange 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.

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.

SOURCE ThromboGenics