- Clinical Trial Data and Emerging Clinical Practice Experience Support HYLENEX Efficacy and Safety -SAN DIEGO, Jan 08, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- 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
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(R), 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.
Halozyme Contact Media Contacts
David A. Ramsay Karen Sparks / Joleen Schultz
Chief Financial Officer Mentus
(858) 704-8260 (858) 455-5500, x275/x215
SOURCE Halozyme Therapeutics, Inc.