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news.Omrix Biopharmaceuticals has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate. This is said to be the first clinical trial that will evaluate the Fibrin Pad's performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ.
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The Phase II clinical trial in Israel is being conducted simultaneously with the Phase II clinical trial in the US, which commenced on March 27, 2008 and is under an investigational new drug application that was filed with the FDA in November 2007.
The Israel study will enroll up to 30 patients undergoing partial nephrectomy, who will be randomized into two treatment arms, 10 patients will be treated in accordance with the standard of care and 20 patients will be treated with the Fibrin Pad applied directly onto the solid organ.
The endpoints will measure both safety and efficacy. The primary efficacy endpoint will measure time to hemostasis at 10 minutes and if any re-bleeding occurs during a subsequent six minute observation period. The clinical trial has a one month follow-up period.
The Fibrin Pad is a breakthrough convergence product candidate comprised of biological components in a biodegradable device. In collaboration with Ethicon, a Johnson & Johnson company, the Fibrin Pad is being developed for the management and rapid control of mild, moderate and severe bleeding.