Baxter Presents Data from Interim Analyses of Phase III Clinical Trial of HyQ at European Society for Immunodeficiencies Meeting
Data Presented Include Analyses of Tolerability, Bioavailability and Infusion Volumes, Intervals and Rates of Baxter's HyQ
ISTANBUL, October 6, 2010 - Data from interim analyses of a Phase III clinical study in patients with primary immune deficiency (PID) who received Baxter's HyQ were presented at the 26th meeting of the European Society for Immunodeficiencies (ESID) in Istanbul, Turkey. HyQ is an immune globulin (IG) therapy facilitated subcutaneously by recombinant human hyaluronidase, a dispersion and permeation enhancer.
The interim data showed that 28 out of 29 HyQ treated study participants were able to infuse IG under the skin at infusion volumes, intervals and rates equivalent to their previous intravenous administration of IG. The majority of HyQ infusions were administered using a single injection site. The mean maximum infusion rate with HyQ was 245 mL per hour at a single injection site with a mean infusion time of 2.4 hours, which is comparable to intravenous administration. In a tolerability assessment of HyQ, most treatment-related adverse events were mild and localized to the infusion site and included pain and inflammation.
"Currently, patients with primary immune deficiency have to choose between monthly intravenous or weekly subcutaneous immune globulin therapy, which can require multiple injection sites. These data suggest that HyQ, if approved by the FDA, may combine advantageous features of both treatment options by enabling patients with primary immune deficiency to self-administer a full dose of IG treatment with one injection, once a month," said Richard L. Wasserman, M.D., Ph.D., Clinical Professor of Pediatrics at University of Texas Southwestern Medical School, an investigator in the Phase III trial.
In a separate interim analysis based on 23 participants from the same Phase III study, the median dose required to achieve a similar systemic IG exposure to the intravenous administration dose was 107 percent of the intravenous dose for HyQ, compared to 137 percent of the intravenous dose for traditional subcutaneous administration. This translated to a median four-week dose of 507 mg/kg for HyQ, 609 mg/kg for traditional subcutaneous administration and 480 mg/kg for intravenous administration, suggesting that HyQ achieves bioavailability comparable to intravenous administration.
The primary endpoint of the Phase III HyQ study, which has enrolled 89 primary immunodeficiency patients in North America, is prevention of acute serious bacterial infections. The benefit-risk profile of HyQ will be determined upon study completion.
"Baxter has made a commitment to researching and developing innovative therapeutic advances for patients with primary immune deficiency to help them further individualize their care, and HyQ is reflective of that commitment. The interim results for HyQ are encouraging as we work to bring this therapeutic option to patients," said Hartmut Ehrlich, M.D., vice president of global research and development and medical affairs for Baxter BioScience.
Copies of the posters presented at ESID are available at www.baxter.com.
HyQ is an IG therapy facilitated subcutaneously by recombinant human hyaluronidase, a dispersion and permeation enhancer. The IG is a 10% solution that is prepared from large pools of human plasma to assure a broad spectrum of antibodies. The recombinant human hyaluronidase locally and transiently degrades hyaluronan, thus facilitating absorption and dispersion of IG. Hyaluronan is a naturally occurring, space-filling, gel-like substance that is a component of normal tissues, such as skin and cartilage, throughout the body.
HyQ is being developed by Baxter using a recombinant human hyaluronidase technology platform licensed from Halozyme Therapeutics, Inc.
About the Phase III Study
The ongoing Phase III study is a prospective, open-label, non-controlled design that is being conducted in 89 participants in 15 centers in the U.S. and Canada. The study is evaluating the safety and effectiveness of HyQ for the prevention of acute serious bacterial infections, and the pharmacokinetic parameters of HyQ compared to IG administered intravenously. Enrollment in this study was completed during July 2009. The study is expected to be completed by the end of 2010.
About Primary Immunodeficiency
Primary immunodeficiency (PID) patients often require plasma-derived IG as a life-saving therapy to prevent serious, sometimes fatal, infections. The two primary routes of administration of IG today are intravenous administration and subcutaneous administration. Intravenous administration allows for large amounts of IG to be delivered less frequently (e.g., once every three to four weeks), but often is associated with more systemic side effects and typically requires a trained individual to deliver the IG. Subcutaneous administration has fewer systemic side effects, but usually requires more frequent (e.g., once every week or more often) administration because of the limited volumes of IG that are usually delivered under the skin.
Halozyme Therapeutics (NASDAQ:HALO) is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Baxter and Roche to apply Enhanze technology to biological therapeutics. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information, visit www.halozyme.com.
Baxter International Inc. (NYSE:BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning HyQ, including with respect to the ongoing Phase III study evaluating the safety and effectiveness of this therapy. 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; actions of regulatory bodies and other governmental authorities; additional clinical results demonstrating the safety and effectiveness of the therapy; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.