SAN DIEGO, June 15, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today presented a scientific poster highlighting the CONSISTENT 1 trial results at the 74th Scientific Sessions of the American Diabetes Association in San Francisco. The CONSISTENT 1 trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S. Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes (T1DM) receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. Data reported in the presentation show that the study's primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment was met. In addition to other trial data, the poster also presents data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulations in comparison to no pre-treatment.
ADA Poster Presentation Details Title: "Recombinant Human Hyaluronidase Pretreatment of CSII Cannula Sites Provides Comparable Glycemic Control with Reduced Hypoglycemia in T1DM Compared to Usual CSII" Abstract #: 85-LB, June 15, 2014, 12:00 p.m. - 2:00 p.m. PDT Category: 01-B Clinical Therapeutics / New Technology - Insulin Location: Poster Hall D - North
Additional Study Details The CONSISTENT 1 (CONtinuous Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes) trial is evaluating the safety and efficacy of Hylenex® recombinant and a new formulation of Hylenex under FDA review in a six month trial with an 18 month extension phase in 455 patients with type 1 diabetes. The primary efficacy endpoint is comparison of change from baseline in A1C levels at six months. Secondary endpoints are hypoglycemia rates, hyperglycemia comparisons, glucose variability and safety endpoints including adverse events, local tolerability and immunogenicity.
About Hylenex® recombinant (hyaluronidase human injection) Hylenex® recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption 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, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. 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, attributes and outcomes regarding the use of Hylenex® in the CSII setting) 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 typically, but not always, 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 unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2014.
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