SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced it has started a Phase 2 study of proprietary recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin(R) R (regular insulin human injection) and with Humalog(R) (insulin lispro) in Type 1 diabetic patients. This study is designed to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics (PK) after administration of each of four study drugs: Humulin R with and without rHuPH20 and Humalog with and without rHuPH20.
“We are proud to begin this Phase 2 clinical trial in our insulin program and believe this study will provide valuable insight into how the co- administration of our rHuPH20 enzyme with two currently available insulin products could lead to significant patient benefits such as better glycemic control, less hypoglycemia, and more convenient injection timing,” declared Jonathan Lim, M.D., President and CEO of Halozyme. “We have achieved our goal of advancing our Phase 2 insulin program into the clinic before the end of the year and I congratulate the Halozyme team for its outstanding performance.”
This exploratory, crossover design, single blind, open label, liquid meal Phase 2 study is designed to collect data on at least 20 patients who complete the study. The study allows for insulin dose titration and each patient will receive a minimum of four and up to three additional study drug injections that include Humalog and Humulin R with and without rHuPH20. Study drug will be injected subcutaneously into the abdomen immediately prior to ingestion of a standardized liquid meal.
The primary endpoint, a PK measure, will be the area under the curve for plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data, as well as blood glucose concentration at various time points. Safety data such as adverse reactions, hypoglycemia, blood chemistry, and injection site tolerability will be collected, measured and evaluated. Patients may be on study for up to an estimated 14 weeks from screening to completion and the results should be available for presentation at a medical or scientific forum in mid-2009.
Summary of Results Reported for Phase 1 Study
Halozyme conducted a Phase 1 euglycemic clamp study in 26 volunteer subjects who received an injection of Humulin R or Humalog with and without rHuPH20. The trial showed that the co-injections were well tolerated and demonstrated faster insulin absorption and shorter time to peak concentration for the insulin plus enzyme combination compared to insulin alone. Metabolic effects such as glucose lowering activity for the combination of insulin plus rHuPH20 were also greater and occurred earlier than for insulin administered alone. In addition, the combination of Humulin plus rHuPH20 demonstrated faster insulin absorption and a shorter time to peak concentration when compared to Humalog alone.
Results (http://www.halozyme.com/images/ADA 2008 Poster legal.pdf) of the Phase 1 study were presented at the American Diabetes Association 68th Scientific Sessions in June 2008 as a late breaking abstract. By making mealtime insulin faster acting, which shifts insulin exposure and glucose lowering activity to earlier times and away from late postprandial times, insulin kinetics and activity for the combination of insulin plus rHuPH20 more closely mimics natural, endogenous prandial insulin release.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the drug delivery, endocrinology, oncology, and dermatology markets. The company’s portfolio of products and product candidates 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. Its key partnerships are with Roche to apply Enhanze Technology to Roche’s biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter’s biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase(R), for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need. For more information visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning (i) the potential benefits of co-formulating rHuPH20 with insulin and an insulin analog and (ii) plans to present the results of this and additional 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-K, 10-Q, and other filings with the Securities and Exchange Commission.
CONTACT: Robert H. Uhl, Senior Director, Investor Relations of Halozyme
Therapeutics, Inc., +1-858-704-8264, ruhl@halozyme.com; or Media, Karen
Sparks, +1-858-455-5500, ext. 275, karen@mentus.com, or Joleen Schultz,
+1-858-455-5500, ext. 215, jschultz@mentus.com, both of Mentus for Halozyme
Therapeutics, Inc.
Web site: http://www.halozyme.com/
