Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Key pharmacokinetic (PK) and glucodynamic (GD) improvements observed inthe study include:
By making mealtime insulins faster, i.e., shifting insulin exposure andglucose lowering activity to earlier times and away from late postprandialtimes, combination with rHuPH20 yielded a profile of insulin kinetics andactivity more like that of natural, endogenous prandial insulin release.
Diabetes mellitus is an increasingly prevalent, costly conditionassociated with substantial morbidity and mortality. Attaining andmaintaining normal blood sugar levels to minimize the long term clinical risksis a key treatment goal for diabetic patients. The timing of insulinadministration with meal ingestion is critical to effective control of bloodsugar levels. An ideal insulin would closely mimic normal physiologic mealtimeinsulin release.
"If these insulin kinetics can be replicated in studies with diabeticpatients, the co-formulation of rHuPH20 with recombinant insulin products mayclose the gap between currently available therapies and endogenous physiologicinsulin release," explained Richard C. Yocum, MD, Vice President of ClinicalDevelopment and Medical Affairs at Halozyme. "The potential benefits of sucha combination include better overall glycemic control and simplified injectiontiming."
rHuPH20 is the active ingredient in an FDA-approved product for use as anadjuvant to increase the dispersion and absorption of other injected drugs.Halozyme plans to conduct additional clinical trials in its insulindevelopment program, including a study in diabetic patients later in 2008.
The Phase I crossover, euglycemic clamp study was conducted in 26 healthymale volunteers. The study had two stages: the first stage compared the PK andGD of Humalog injected subcutaneously (SC) with and without rHuPH20, and thesecond stage compared the PK and GD of Humulin R injected SC with and withoutrHuPH20.
Compared to Humalog and Humulin R alone, rHuPH20 had the following effectson PK and GD:
The study results were presented in full at the American DiabetesAssociation's 68th Scientific Sessions in San Francisco as a late breakingabstract. The poster from the ADA presentation is available on Halozyme'swebsite (www.halozyme.com)
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix for the drug delivery, metabolism,oncology and dermatology markets. The company's portfolio of products andproduct candidates is based on intellectual property covering the family ofhuman enzymes known as hyaluronidases. The company's Enhanze(TM) Technologyis a novel drug delivery platform designed to increase the absorption anddispersion of biologics. Its key partnerships are with Roche to apply EnhanzeTechnology to Roche's biological therapeutic compounds for up to 13 targetsand with Baxter to apply Enhanze Technology to Baxter's biological therapeuticcompound, GAMMAGARD LIQUID 10%. In addition, the company has received FDAapproval for two products: Cumulase(R), for use in in-vitro fertilization, andHYLENEX, for use as an adjuvant to increase the absorption and dispersion ofoth
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