Healthcare Industry News: Baxter International
News Release - January 8, 2008
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With HylenexClinical Trial Data and Emerging Clinical Practice Experience Support HYLENEX Efficacy and Safety
SAN DIEGO, Jan. 8 (HSMN NewsFeed) -- Halozyme Therapeutics, Inc. (Nasdaq: HALO ), a biopharmaceutical company developing and commercializing products based on the extracellular matrix, today announced the Original Article publication of the INFUSE-LR clinical trial results in the Journal of Palliative Medicine, the official journal of the American Academy of Palliative Medicine (Thomas JR et al. J Pall Med. December 2007; 19(6): 1312-1320). The authors of this publication concluded from this volunteer subject study that clinically relevant fluid volumes can be rapidly delivered subcutaneously (Sub-Q) with HYLENEX in a well-tolerated manner without the need for an infusion pump. The findings suggest that this method of hydration could potentially replace intravenous infusions in many clinical settings and that further studies with HYLENEX, in patients, are warranted.
This call for additional study of HYLENEX in the clinical setting with patients has been addressed in an earlier publication in this same journal (Pirrello R et al. Initial Experiences with Subcutaneous Recombinant Human Hyaluronidase (rHuPH20). J Pall Med. 2007;10(4):861-864). In this first publication of actual clinical experience with a series of patients administered the HYLENEX marketed drug product, 32 patients were treated with HYLENEX in a hospice setting over a six-month period. Of these, 26 received HYLENEX to enhance Sub-Q infusion with standard hydration fluids (normal saline, 5% dextrose in saline, and 5% dextrose) for symptom control of delirium, myoclonus, and mild-to-moderate dehydration. Flow rates up to 500 mL/hour were attained without difficulty. Electrolyte replacement in hydration fluid was achieved without incident in several patients. In addition to use for fluid hydration, six patients received HYLENEX to enhance Sub-Q infusion of nine different medications (hydromorphine, lidocaine, dexamethasone, haloperidol, midazolam, ondansetron, famotidine, sufentanil, and glycopyrrolate), primarily because the medication dosage required Sub-Q flow rates greater than the standard 3 mL/hour. There were no significant adverse events (AEs); induration at the infusion site occurred in one patient receiving hydration and higher than expected serum lidocaine concentration was observed in another patient.
As previously reported (see February 8, 2006 Halozyme press release), the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer's clinical trial, or INFUSE-LR study, was designed to determine the Sub-Q infusion flow rate of Lactated Ringer's (LR) solution with and without HYLENEX, determine the Sub-Q infusion flow rate dose response to HYLENEX over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24-gauge catheters. The key findings from this study are:
In every subject tested in this study, HYLENEX injection preceding the gravity-driven LR infusions enabled flow rates approximately 250% to 400% faster than the infusions without HYLENEX. The overall mean flow rate for Sub-Q infusion with HYLENEX was 464 mL/hr versus 118 mL/hr with placebo (p<0.0001).
Despite the faster rate of LR infusion into the HYLENEX-assisted arms, the HYLENEX arms demonstrated significantly less edema in all HYLENEX dose groups and all timepoints during infusions. Across the three HYLENEX dose cohorts, 94% of subjects had moderate or severe arm edema with placebo compared to 17% with HYLENEX (p < 0.0001).
AEs occurring following treatment were mild to moderate in severity, localized to the infusion sites, and evenly distributed between placebo and HYLENEX treatment arms. There were no severe or serious AEs.
In the double-blinded global preference ranking, both study subjects and the Investigator preferred, in 92% of cases across the three dose cohorts, the HYLENEX-assisted arms for Sub-Q infusions rather than placebo arms (p < 0.0001).
The Journal of Palliative Medicine is an interdisciplinary journal that reports on the clinical, educational, legal, and ethical aspects of care for seriously ill and dying patients. It includes coverage of the latest developments in drug and non-drug treatments for patients with life-threatening diseases. The journal reports on the development of palliative care programs around the U.S. and the world and innovation in palliative care education.
HYLENEX is a liquid injectable drug product formulation that includes the active pharmaceutical ingredient recombinant human hyaluronidase (rHuPH20) and is approved by the U.S. Food and Drug Administration (FDA) for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for Sub-Q fluid administration. HYLENEX is the first and only FDA-approved hyaluronidase from a recombinant human source. Sub-Q hydration is the introduction of fluids under the skin to replace inadequate intake or excessive loss of water and electrolytes during illness or operation.
HYLENEX recombinant (hyaluronidase human injection, rHuPH20) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. Discontinue HYLENEX recombinant if sensitization occurs. Hyaluronidase should not be applied directly to the cornea, and should not be injected around infected or acutely inflamed areas, nor used to reduce the swelling of bites or stings. Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. For more information about HYLENEX please visit http://www.HYLENEX.com or call 1-800-262-3784. HYLENEX is a trademark of Baxter International Inc.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology and dermatology markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase®, for use in in vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning HYLENEX clinical trial results) 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.
Source: Halozyme Therapeutics
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