OPKO Presented New Data at International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress on Its Long-Acting Clotting Factor VIIa

New Preclinical Data further demonstrate the safety and efficacy of MOD-5014 (FVIIa -CTP) for both Intravenous and Subcutaneous Administration

OPKO Health, Inc. presented new data on its long-acting clotting Factor VIIa-CTP (MOD-5014) at the International Society on Thrombosis and Haemostasis Congress (ISTH 2015) held June 20-25, 2015 in Toronto, Ontario, Canada. OPKO’s Factor VIIa-CTP is a next-generation investigational therapy currently in a Phase 2a U.S. based study for the treatment of patients with hemophilia.

Currently, Factor VIIa therapy is available only as an intravenous (IV) formulation, which requires frequent multiple infusions to treat a bleeding episode due to Factor VIIa’s short half-life. In addition, the requirement for multiple weekly infusions can be onerous for patients interested in preventative prophylactic treatment of the disease, especially children.

Previously presented pre-clinical data utilizing both intravenous and subcutaneous administration in hemophilic animal models demonstrated the long acting properties of Factor VIIa-CTP as compared to commercial rFVIIa, with superior half-life, reduced bleeding and increased survival for a significantly longer period.

Five abstracts were accepted for presentation at the ISTH conference. The following abstracts were presented from 5:00-7:00 p.m. local time on June 23-24th.

PO062-TUE: EX-VIVO AND IN-VITRO COMPARATIVE ASSESSMENT OF MOD-5014 (FACTOR VIIA-CTP), A NOVEL LONG-ACTING COAGULATION FACTOR TO RECOMBINANT FVIIA

PO550-TUE: EFFECT OF A CARBOXY-TERMINAL PEPTIDE (CTP) ON FACTOR VIIA ACTIVITY

PO594-WED: COMPREHENSIVE ASSESSMENT OF THE SAFETY AND EFFICACY OF FACTOR VIIA-CTP SUPPORTING PHASE 2A STUDY

PO595-WED: FACTOR VIIA-CTP, A LONG-ACTING COAGULATION FACTOR PROPOSING A NOVEL SUBCUTANEOUS (SC) ROUTE OF ADMINISTRATION FOR PROPHYLACTIC TREATMENT -EFFICACY AND SAFETY IN PREPARATION FOR FIRST IN HUMAN STUDY

PO048-WED: ASSESSMENT OF MOD-5014, A LONG ACTING FVIIA, PHARMACOKINETIC, PHARMACODYNAMICS AND CORRECTION OF HEMOPHILIC COAGULOPATHY IN DOGS WITH HEMOPHILIA A AS PART OF THE PREPARATION FOR FIRST IN HUMAN STUDY