SAN DIEGO, Oct. 27, 2011 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced positive results from a study in patients with type 1 diabetes that receive their insulin therapy via pumps. The Phase 1b study was conducted as a randomized, double-blind, crossover design, to determine insulin pharmacokinetics, glucodynamics, safety and tolerability of rHuPH20 (recombinant human hyaluronidase) as a single injection prior to the start of three days of NovoLog® insulin aspart pump infusion therapy. The data demonstrated that pre-administration of 150 units of rHuPH20 (approximately 1.3 micrograms of enzyme) led to consistent insulin exposure over the infusion set life and superior glucose control following meals.
"The more consistent physiologic insulin absorption profiles observed over infusion set life in these studies are promising," said Daniel Einhorn, MD, FACP, FACE, Clinical Professor of Medicine at the University of California, San Diego and Medical Director of the Scripps Whittier Diabetes Institute. "Reducing the variability of insulin absorption should provide patients on insulin pump therapy improved ability to control diabetes while reducing risks of hypoglycemia."
Clinical Study and Results
The study compared pharmacokinetic (PK) and glucodynamic (GD) responses during euglycemic glucose clamp studies and responses to standardized mixed meal challenges administered in conjunction with individualized doses of insulin aspart, throughout the infusion set use with and without a single injection of rHuPH20 through the catheter set. The study also evaluated safety and local tolerability of rHuPH20 over the course of 72 hours of inpatient pump delivery, following pre-administration of rHuPH20 through subcutaneous infusion.
Compared to insulin aspart alone, pre-administration with rHuPH20 reduced the variability in insulin exposure and action profiles observed with continuous insulin infusion and provided a consistent ultrafast profile over 3 days of use.
In the test meal setting, the consistent ultrafast profile with pre-administration of rHuPH20 led to consistently reduced postprandial excursions.
Insulin aspart infusion with and without rHuPH20 pretreatment was similarly well tolerated.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the insulin, cancer, 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 and additional enzymes that affect the extracellular matrix. 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 Roche, Baxter, ViroPharma and Intrexon to apply Enhanze™ technology to therapeutic biologics including Herceptin®, MabThera®, immunoglobulin, Cinryze® and recombinant human alpha 1-antitrypsin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the timing, scope and outcomes of our clinical trials as well as expected activities under our collaborative partnerships) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including clinical trial enrollment and results, regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
Chief Financial Officer
|SOURCE Halozyme Therapeutics, Inc.|
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