SAN DIEGO, April 14, 2011 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced results from a study in type 1 diabetes patients who receive their insulin treatment with a pump demonstrating that Aspart-PH20, a formulation of Halozyme's rHuPH20 (recombinant human hyaluronidase) with the active ingredient in NovoLog®, accelerates insulin absorption and shortened its duration of action. These preliminary results represent the first reported experience in a clinical trial where patients received rHuPH20 enzyme combined with an insulin analog as a continuous subcutaneous insulin infusion (CSII) over 72 hours administered with an insulin pump. Halozyme presented these results today at the American Association of Clinical Endocrinologists (AACE) meeting in San Diego.
"The initial results from Halozyme's first pump study show that the faster pharmacokinetic and glucodynamic findings consistently demonstrated with mealtime subcutaneous insulin injections are also observed in the CSII setting," stated Doug Muchmore, M.D., vice president of endocrinology clinical development. "The ultrafast profile of analog insulin with rHuPH20 is well suited for use with insulin pumps."
Key Findings from Today's Oral Presentation
The first stage of this double blind crossover design Phase 1 clinical trial compared Aspart-PH20 to aspart alone in type 1 diabetes patients who administered their insulin over 72 hours with an insulin pump. The cumulative insulin exposure during the first 60 minutes following a bolus infusion was 64% greater for the Aspart-PH20 formulation compared to aspart alone (p < 0.0001). Insulin exposure beyond 2 hours after the bolus decreased by 42% for the combination compared to aspart alone (p = 0.0003). These results clearly demonstrate the faster-in/faster-out pharmacokinetic (PK) profile for the combination Aspart-PH20. The faster PK also translated into accelerated insulin action for the combination treatment. As demonstrated with a euglycemic clamp procedure, Aspart-PH20 action in the first 2 hours was 20% greater relative to aspart alone (p = 0.047) with 37% less insulin action beyond 4 hours after injection (p = 0.008). These results have been obtained for the first 13 patients and enrollment of an additional 5 patients is continuing for the aspart stage of the study. So far, the overall safety and adverse event profiles for Aspart-PH20 and aspart alone were comparable and both treatments were well tolerated. Additional parameters important for pump use are being tested, with data available later in 2011.
The goal of Halozyme's Ultrafast Insulin program is to develop a best-in-class mealtime insulin product compared to the currently prescribed analogs that participate in the growing $3.8 billion worldwide prandial insulin market. Additional information about Halozyme's on-going Ultrafast Insulin trials can be found at clinicaltrials.gov using the identifiers NCT01275131, NCT01194245 and NCT01194258.
Halozyme Therapeutics 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 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 to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. 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, (i) the timing of results from on-going clinical trials, (ii) the benefits of insulin with rHuPH20 combinations, and (iii) the conclusions drawn from the trials) 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 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.
Halozyme Contact Robert H. Uhl Senior Director, Investor Relations (858) 704-8264 [email protected]