-- Daily administration of rHuPH20 for one week was well tolerated via
either IV or SC delivery at a daily bolus dose of 600,000 U/kg
(5 mg/kg). No test article-related changes were observed in any
toxicology parameters and no systemic enzyme accumulation was observed.
-- A 3-month interim analysis from an ongoing 39-week chronic toxicity
study with weekly dosing up to 240,000 U/kg revealed no changes in
standard toxicity parameters or in male fertility assessment.
"These studies further expand the safety database for rHuPH20 in both dose and duration, and support the potential use of rHuPH20 from Halozyme's new manufacturing process in chronic applications," said Walter Bee, PhD, Halozyme's Vice President of Preclinical Development. "We anticipate that this toxicology package will be supportive of our current and future Enhanze(TM) Technology partners' regulatory applications."
About Enhanze Technology
Enhanze Technology is Halozyme's proprietary drug delivery technology based on recombinant human hyaluronidase (rHuPH20), a recombinant form of the naturally occurring human enzyme being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. When combined or co-formulated with certain injectable drugs, Enhanze(TM) Technology can act as a "molecular machete" to facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin. Molecules as large as 200 nanometers may pass freely through the perforated extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical
|SOURCE Halozyme Therapeutics, Inc.|
Copyright©2008 PR Newswire.
All rights reserved