ProFibrix Initiates Phase II Clinical Trial Of Its Lead Topical Hemostat Product Fibrocaps(TM)

Main Category: Blood / Hematology
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Jun 2009 - 2:00 PDT

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ProFibrix B.V. announced the start of the company's Phase II clinical trial for Fibrocaps(TM), the company's lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate bleeding during liver surgery. ProFibrix expects to complete the study before the end of 2009.

Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.

ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.

Jaap Koopman, PhD, Chief Executive Officer, said: "The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval."

Source
ProFibrix B.V.