hyaluronidase
as an adjuvant to increase the absorption and dispersion of
co-injected small molecule drugs, to Halozyme's knowledge, this was
the first clinical trial conducted to support the benefits and
safety of rHuPH20 for use with large molecule agents, such as
monoclonal antibodies and other large molecule biologics. Most
therapeutic antibodies are 60% to 70% systemically bioavailable
following SC injection, allowing room for improvement in
absorption. Other therapeutic large molecule agents have even lower
systemic bioavailability, and still other agents may not be
developed for SC administration because of low systemic
bioavailability through this route of administration. rHuPH20 is
the first and only hyaluronidase from a recombinant human source
that is FDA-approved, currently in a 150 U product
configuration.
"The remarkable findings from this clinical trial, estimating
that co-injection of rHuPH20 in high doses can boost the SC
absolute bioavailability of an LPMT from 64% to essentially 100%,
validates similar findings from animal models," said Richard C.
Yocum, MD, Vice President of Clinical Development and Medical
Affairs at Halozyme. "We have shown previously in two different
animal species and with three different representative large
molecules that rHuPH20 locally co-injected with the large molecule
increases the bioavailability in a rHuPH20 dose-dependent fashion
and to essentially complete absorption."
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. The company's
Enhanze(TM) Technology is a novel drug delivery platform designed
to increase the absorption and dispersion of biologics. In
addition, the company has received FDA approval for two pr
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