PHILADELPHIA, June 9, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today presented results from a Phase 4 study of Hylenex® recombinant (hyaluronidase human injection) in sensor augmented insulin analog pump (SAP) therapy in patients living with Type 1 diabetes. Interim data from this study indicate that pre-administration of Hylenex recombinant in the SAP provided a consistent ultrafast insulin action profile over the infusion set life that resulted in improved glucose control. A presenter will be available to discuss the poster on Sunday, June 10 from 12:00 - 2:00 PM EDT.
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"Pre-administration of Hylenex at the time of infusion set change may provide more consistent insulin exposure and absorption, and improve control of postprandial hyperglycemia," said Marcus Hompesch, M.D., President and CEO, Profil Institute for Clinical Research, Chula Vista, CA. "Although preliminary, these data look encouragingand indicate that Hylenex could help people living with Type 1 diabetes reduce glucose fluctuations that are problematic and achieve tighter glucose control."
The outpatient study compared the effects of treatment with and without Hylenex recombinant in SAP therapy in each patient. Every three days, immediately following infusion site change, a dose of 150 Units (1.25 micrograms in 1.0 ml) of Hylenex recombinant or sham injection was administered through the infusion cannula at the time of infusion site insertion. In order to maintain a double-blind study design, the Hylenex recombinant injections were administered by a trained medical professional who was not otherwise involved in the study.
Interim data from the study confirm that Hylenex recombinant provided an accelerated and more consistent insulin action profile which resulted in meaningful, statistically significant improved postprandial glucose control. (See Table 1 below.)
Table 1
PPG (mg/dL) | Sham | Hylenex | Treatment Effect | |||
Mean | SD | Mean | SD | Difference | p-value | |
1 hr | 184 | 46 | 143 | 34 | -44 | <.0001 |
90 min | 175 | 63 | 134 | 54 | -43 | <.0001 |
2 hr | 162 | 76 | 131 | 62 | -33 | .001 |
Adverse events were mild, generally rare, resolved without sequelae and were consistent with the known safety profile of Hylenex. Hypoglycemia occurred for up to 5 percent of Continuous Glucose Monitoring (CGM) readings and was comparable for each treatment.
Study Design
This seven week, randomized, controlled, double-blind, two-way cross-over random sequence outpatient Phase 4 clinical pharmacology study compared the effects of treatment with and without Hylenex recombinant in SAP therapy in patients with Type 1 diabetes. Data from 11 out of 18 planned subjects have been analyzed. Approximately every three days, Hylenex recombinant or sham injection were administered through the infusion cannula at the time of infusion set insertion. The primary endpoint of the study was insulin absorption. Secondary outcomes included reduced glycemic excursions, changes in insulin absorption and safety and tolerability of the subcutaneous infusion.
About Hylenex® recombinant (hyaluronidase human injection)
Hylenex recombinant is a tissue permeability modifier approved for use by the U.S. Food and Drug Administration. It temporarily makes the tissue beneath the skin more permeable and facilitates the absorption of fluids and medicines into the systemic circulation. Hylenex recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography.Hylenex recombinant is contraindicated in patients with a known hypersensitivity to recombinant human hyaluronidase or any excipient used to make the drug.The most frequently reported adverse reactions with Hylenex recombinant have been local injection site reactions, such as erythema and pain. For additional information or full Prescribing Information visit www.hylenex.com or www.halozyme.com.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at 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 possible benefits and attributes of the pre-administration of Hylenex recombinant at the time of infusion set change) 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 7, 2012.
Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
858-699-9166
aerickson@halozyme.com
SOURCE Halozyme Therapeutics, Inc.
