Baxter Announces Therapeutic Development Program For First Blood-Free RecombinantVon Willebrand Factor

Baxter Healthcare Corporation announced that the company has initiated a therapeutic program for the development of a recombinant form of von Willebrand factor (VWF), a protein critical to the normal clotting of blood. Preclinical results presented at the American Society of Hematology (ASH) 48th annual meeting held in December (Abstract 1017) suggest that a recombinant VWF therapeutic protein candidate has similar properties to plasma-derived VWF. Baxter will continue to conduct extensive preclinical research before the modified protein will be available for clinical evaluation.

“The initiation of this recombinant VWF therapeutic program is an important strategic landmark as we build upon the success of our plasma/albumin-free platform,” said Hartmut Ehrlich, MD., vice president, global research and development, for Baxter’s BioScience business. “The majority of therapeutic clotting factors continue to be processed using blood-derived components. By applying Baxter’s proven proprietary blood-free processing technology, we are working to develop a therapeutic option that will eliminate the potential risk of blood-borne pathogen transmission for people with von Willebrand disease.”

Characterization of a Recombinant VWF Molecule (Abstract 1017)
At the ASH annual meeting, Baxter scientists presented initial data from experiments analyzing several large-scale batches of recombinant VWF processed using the company’s proprietary blood-free technology, which was subsequently purified. The properties of the purified recombinant proteins were then evaluated in comparison to three plasma-derived VWFs, including two commercially available therapeutic proteins. According to these preliminary data, the recombinant VWF showed comparable properties to the plasma-derived proteins in the various biochemical evaluations, as well as similar pharmacokinetic properties in mouse models of von Willebrand disease. Overall, the results of these preclinical studies suggest that the properties of recombinant VWF both in vitro and in vivo are similar to those of plasma-derived VWF.

About von Willebrand Disease
Von Willebrand disease is the most common inherited bleeding disorder and occurs in one to two percent of the population, affecting both men and women. People with this disease may have low levels of von Willebrand factor, a clotting protein necessary for proper blood coagulation. There are three types of von Willebrand disease, but the majority of cases are Type I, a mild version of the disease. More severe cases, as seen in Type 2 and Type 3, may require infusion of concentrate to increase the amount of circulating von Willebrand factor in order to prevent the breakdown of platelet plugs involved in the initial stage of clotting and to control heavy menstrual bleeding. There is no cure for von Willebrand disease.

Baxter Research and Development
Baxter BioScience focuses its own scientific resources and leverages strategic collaborations to advance the treatment of hemophilia and blood clotting disorders. Building on its history of innovation, the company is developing therapies that will provide less invasive dosing techniques, require less frequent infusions, and/or reduce the potential for inhibitor formation to improve the lives of people with hemophilia.

About Baxter
Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives.

This release includes forward-looking statements concerning the development of a recombinant form of VWF. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements for timely commencement of clinical trials; additional results, including results in humans, demonstrating the safety and efficacy of the product; market acceptance of such products; and other risks identified in the company’s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.

Source:
Baxter International Inc.Press Release
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