Halozyme Therapeutics, Inc.
(Amex: HTI), a biopharmaceutical company developing and commercializing
recombinant human enzymes, today announced it has initiated and dosed the
first three patients in a clinical trial of Enhanze(R) Technology,
Halozyme's enzyme-based drug delivery platform based on recombinant human
PH20 hyaluronidase (rHuPH20), intended in this trial to enhance the
absorption of a representative large molecule protein therapeutic.
"The initiation of this clinical trial takes us another step closer to
further developing the full potential of the human recombinant form of
hyaluronidase," said Richard C. Yocum, MD, Vice President of Clinical
Development and Medical Affairs at Halozyme. "If rHuPH20 can be shown to
enhance the absorption of large molecule therapeutics and confer benefit
either by improved bioavailability, time to absorption, and/or reduced side
effects, this method of drug administration may open up new strategies to
treating patients with regard to doses administered, dosing intervals,
patient tolerability, patient convenience, and health economics."
As a spreading agent, hyaluronidase has traditionally been used to
accelerate the delivery of drugs and fluids, including local anesthetics,
other co-injected drugs, and contrast agents, and for subcutaneous (SC)
fluid replacement. Although a large body of clinical experience supports
the benefits and safety of using hyaluronidase as an adjuvant to increase
the absorption and dispersion of co-injected small molecule drugs, clinical
studies are needed to support the benefits and safety of recombinant human
hyaluronidase use with large molecule agents, such as monoclonal antibodies
and other large molecule biologics. Concerns about the allergenicity and
immunogenicity of repeat dosing of older, animal-derived hyaluronidase have
limited the use of those products in many clinical settings. The recent
availability of rHuPH20, along with its high purity and absence of both
animal pathogens and risk of transmissible spongiform encephalopathies, has
opened up the possibility of many more potential therapeutic uses of this
enzyme.
This current clinical trial is designed to compare the pharmacokinetics
(PK), safety and tolerability of a large molecule protein therapeutic agent
subcutaneously injected both with and without rHuPH20. The dose escalation,
within-patient controlled study will use escalating doses of rHuPH20 and
substitute a standard SC injection of the therapeutic agent with a SC
injection of the protein therapeutic agent combined with rHuPH20. The study
will compare the bioavailability and other PK parameters, along with safety
and tolerability, of the two SC injections, one with and one without
rHuPH20.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
recombinant human enzymes for the drug delivery, palliative care, oncology,
and infertility markets. The company's portfolio of products is based on
intellectual property covering the family of human enzymes known as
hyaluronidases. Halozyme's recombinant human enzymes may replace current
animal slaughterhouse-derived extracts that carry potential risks of animal
pathogen transmission and immunogenicity. The company has received FDA
approval for two products: Cumulase(R), the first and only recombinant
human hyaluronidase for cumulus removal in the IVF process, and Hylenex,
for use as an adjuvant to increase the absorption and dispersion of other
injected drugs and fluids. The versatility of the first enzyme, rHuPH20,
enables Halozyme to develop products as a medical device, drug enhancement
agent, and therapeutic drug.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation,
statements concerning the Company's products under development, product
development plans, regulatory strategy, regulatory filing dates and
clinical trials) that involve risk and uncertainties that could cause
actual results to differ materially from those in the forward-looking
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"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-KSB, 10-Q, and other filings
with the Securities and Exchange Commission.
Halozyme Therapeutics, Inc.
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