Halozyme Initiates First Enhanze Technology Clinical Trial to Improve the Subcutaneous Absorption of a Large Molecule Protein Therapeutic
Date: 18.8.2006
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® 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®, 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 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-KSB, 10-Q, and other filings with the Securities and Exchange Commission.
"Source":[ http://www.bio.com/industryanalysis/industryanalysis_news.jhtml;jsessionid=UN2GJQOUJCU4BR3FQLMCFEWHUWBNSIV0?cid=20700020]
