Surgeons May Turn to A New Biotechnology Product to Solve the Problem of Interoperative Bleeding

Recothrom: A Tool in the Minimally-Invasive Surgeon's Toolbox

By John J. Otrompke, JD

In advance of the 5th Annual Global Bioindustrial and Bioprocessing Forum, biotech company ZymoGenetics announced the results of a Phase II trial examining its newly-FDFA approved product Recothrom in the treatment of 71 serious burn injury patients on April 30th.

Recothrom is a recombinant product which may serve as a substitute for bovine thrombin. “Recothrom is an alternative to bovine plasma, which works with other proteins in the body to help start the clotting that stops bleeding,” said Susan Specht, director of corporate communications at Seattle-based ZymoGenetics.

The burn news was announced at the meeting of the American Burn Association in Chicago. The patients in the study had wound sizes of approximately 15% of the patient’s total body surface area.

Bovine thrombin, the earlier product for oozing and bleeding wounds, was approved in the early 1940s, and was grandfathered in by the FDA, but carried a black box warning until its most recent FDA review and approval in 2007, for an ultra-filtration process that removes non-thrombin proteins. However, Recothrom also showed lower immunogenicity in a Phase II clinical trial, Specht says. In Phase III trials prior to FDA approval, Recothrom has so far been tested in spinal surgery cases, liver resections, peripheral artery bypass, and arterio-venous graft construction.

It may be the rare robotic surgeon to admit that intraoperative bleeding can be a problem in these cases, but as the range of surgical procedures in which robots may be an option expands, it5 is wise to remember that Recothrom may be just another device in your toolkit.

ZymoGenetics, which was formed in 1981, has also outlicensed a number of drugs prior to its breakthrough with Recothrom, and has other novel products in development, such as Atacicept, which is aimed at treating autoimmune disease by blocking two factors, April and BLyS, without totally depleting B-cells like some drugs.

Other products in development at ZymoGenetics include Interleuken-21 and Peg Interferon Lambda, which is aimed hepatitis C.