jurpsy schreef op 8 januari 2015 07:13:
Pharming And Salix Announce First Patient Treated In Clinical Study Of Ruconest® For Prophylaxis Of Hereditary Angioedema
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LEIDEN, THE NETHERLANDS, RALEIGH, NC, 08 January 2015 – Pharming Group NV (EURONEXT: PHARM) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the first patient was treated in their Phase 2 clinical study of Ruconest®, (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg, for prophylaxis in patients with hereditary angioedema (HAE).
HAE patients deficient in C1 inhibitor and with a history of at least four attacks per month are being enrolled in the randomized, double-blind study, in which 30 patients will receive Ruconest® either once or twice weekly, or placebo in each of 3 treatment periods. With the crossover design, all patients will receive each of the dosing regimens. The study will evaluate the safety and efficacy of Ruconest® when used for prophylaxis of angioedema attacks in patients with HAE.
The study will be conducted at sites in Canada, Europe, Israel, and the United States. The trial is being coordinated by principal investigators,
Dr. Marco Cicardi, Professor at the University of Milan, and
Dr. Marc Riedl, Associate Professor and Clinical Director of the US HAEA Angioedema Center at the University of California, San Diego.
“We are pleased to have quickly initiated the treatment phase of this important study, and look forward to its completion later in 2015,” said Bruno Giannetti, MD PhD, Chief Operating Officer of Pharming.
Under the terms of the Pharming-Salix license agreement,
the companies will equally share the development costs for Ruconest® for HAE prophylaxis.
Pharming will receive an undisclosed milestone payment from Salix as and when FDA approval for this additional indication is given.