PHASE II TRIAL OF REPLIGEN'S rPF4

Repligen has started a Phase II study of its recombinant platelet factor 4 product for reversing heparin anticoagulation. The 40-patient, double-blind study will compare rPF4 against the current standard therapy for heparin overdosage, protamine.

Phase I results of intravenous rPF4 were presented at the American Heart Association meeting in Atlanta last month, and revealed that activated partial thromboplastin time, which the use of heparin increases, returned to normal or near-normal levels in 16 out of 18 tested patients. None of the patients treated with rPF4 showed signs of the adverse hematological reactions seen with protamine, such as paradoxical anticoagulation, bradycardia and hypotension.

Repligen is also studying rPF4 in open-labeled, Phase I/II studies as a treatment for Kaposi's sarcoma.