PROLOR Biotech to Present Positive Results From Preclinical Studies of Long-Acting Clotting Factor VIIa-CTP at ISTH 2013
--New Data Show a Simple Subcutaneous Injection of Factor VIIa-CTP Could Potentially Replace Current Therapies Administered Via Infusion--
Press Release: PROLOR Biotech, Inc. – Wed, Jul 3, 2013 7:30 AM EDT
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AMSTERDAM and NES-ZIONA, Israel, July 3, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH), today announced that the company will present new results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia. The data provide further evidence that Factor VIIa-CTP has the potential to be administered by subcutaneous (SC) injection as well as intravenously (IV), which would facilitate its prophylactic use by patients on an ongoing basis. The study results will be discussed in an oral presentation at the XXIV Congress of the International Society of Hemostasis and Thrombosis (ISTH).
Currently available commercial factor VIIa must be administered through IV infusion, which can be onerous for patients. This limits its use for prophylactic treatment and can require frequent administrations if patients are treated only "on demand" when a bleeding episode occurs.
The new preclinical results being presented at the ISTH Congress further confirm the efficacy of PROLOR's long-acting Factor VIIa-CTP and show that it has the potential to be administered using a simple SC injection. The combination of a long-acting product coupled with the ability to be administered by SC injection could change the way that factor VIIa is used, potentially allowing individuals with hemophilia to self-administer the drug at home on a prophylactic basis, improving their quality of life and potentially reducing the need for on-demand treatment of bleeding episodes.
Dr. Abraham Havron, CEO of PROLOR, commented, "We have previously presented data in animal models of hemophilia showing that Factor VIIa-CTP demonstrated long-acting properties compared to commercially available factor VIIa. These new data reflect our extensive recent work confirming those data and also assessing the potential of hGH-CTP to be administered by SC injection, which could be transformative for some hemophilia patients. Based on these exciting results, we expect to initiate two independent clinical programs for Factor VIIa-CTP in 2014—one for on-demand and prophylactic treatment of hemophilia using the IV route and a second for prophylactic treatment using the SC route."
The data will be presented by Dr. Gili Hart, Vice President, Pre-Clinical Development and Clinical Pharmacology at PROLOR and head of the company's long-acting clotting factors program. Dr. Hart's presentation, "A long-acting FVIIa-CTP proposing an improved prophylactic and on-demand treatment for hemophilic patients following SC and IV administration - evaluation in animal models," will be presented on July 4, 2013, at 9:15 am local time....
