SAN DIEGO, Nov. 3 Halozyme Therapeutics, Inc.(Nasdaq: HALO), a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix, today announced it has started aPhase 2 study of proprietary recombinant human hyaluronidase enzyme (rHuPH20)co-formulations with Humulin(R) R (regular insulin human injection) and withHumalog(R) (insulin lispro) in Type 1 diabetic patients. This study isdesigned to compare glycemic control of a standardized liquid meal challengeand insulin pharmacokinetics (PK) after administration of each of four studydrugs: Humulin R with and without rHuPH20 and Humalog with and withoutrHuPH20.
"We are proud to begin this Phase 2 clinical trial in our insulin programand believe this study will provide valuable insight into how the co-administration of our rHuPH20 enzyme with two currently available insulinproducts could lead to significant patient benefits such as better glycemiccontrol, less hypoglycemia, and more convenient injection timing," declaredJonathan Lim, M.D., President and CEO of Halozyme. "We have achieved our goalof advancing our Phase 2 insulin program into the clinic before the end of theyear and I congratulate the Halozyme team for its outstanding performance."
This exploratory, crossover design, single blind, open label, liquid mealPhase 2 study is designed to collect data on at least 20 patients who completethe study. The study allows for insulin dose titration and each patient willreceive a minimum of four and up to three additional study drug injectionsthat include Humalog and Humulin R with and without rHuPH20. Study drug willbe injected subcutaneously into the abdomen immediately prior to ingestion ofa standardized liquid meal.
The primary endpoint, a PK measure, will be the area under the curve forplasma insulin concentration from zero to 60 minutes after injection.Secondary endpoints will include additional PK data, as well as blood glucoseconcentration at various time points. Safety data such as adverse reactions,hypoglycemia, blood chemistry, and injection site tolerability will becollected, measured and evaluated. Patients may be on study for up to anestimated 14 weeks from screening to completion and the results should beavailable 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 volunteersubjects who received an injection of Humulin R or Humalog with and withoutrHuPH20. The trial showed that the co-injections were well tolerated anddemonstrated faster insulin absorption and shorter time to peak concentrationfor the insulin plus enzyme combination compared to insulin alone. Metaboliceffects such as glucose lowering activity for the combination of insulin plusrHuPH20 were also greater and occurred earlier than for insulin administeredalone. In addition, the combination of Humulin plus rHuPH20 demonstratedfaster insulin absorption and a shorter time to peak concentration whencompared to Humalog alone.
Results (http://www.halozyme.com/images/ADA 2008 Poster legal.pdf) of thePhase 1 study were presented at the American Diabetes Association 68thScientific Sessions in June 2008 as a late breaking abstract. By makingmealtime insulin faster acting, which shifts insulin exposure and glucoselowering activity to earlier times and away from late postprandial times,insulin kinetics and activity for the combination of insulin plus rHuPH20 moreclosely mimics natural, endogenous prandial insulin release.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix for the drug delivery,endocrinology, oncology, and dermatology markets. The company's portfolio ofproducts and product candidates is based on intellectual property covering thefamily of human enzymes known as hyaluronidases. The company's Enhanze(TM)Technology is a novel drug delivery platform designed to increase theabsorption and dispersion of biologics. Its key partnerships are with Rocheto apply Enhanze Technology to Roche's biological therapeutic compounds for upto 13 targets and with Baxter to apply Enhanze Technology to Baxter'sbiological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, thecompany has received FDA approval for two products: Cumulase(R), for use inin-vitro fertilization, and HYLENEX, for use as an adjuvant to increase theabsorption and dispersion of other injected drugs and fluids. HYLENEX ispartnered with Baxter International Inc. Halozyme also has a number ofdifferent enzymes in its portfolio that target significant areas of unmetmedical need. For more information visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth aboveinclude forward-looking statements (including, without limitation, statementsconcerning (i) the potential benefits of co-formulating rHuPH20 with insulinand an insulin analog and (ii) plans to present the results of this andadditional clinical trials) that involve risk and uncertainties that couldcause actual results to differ materially from those in the forward-lookingstatements. The forward-looking statements are also identified through use ofthe words "believe," "enable," "may," "will," "could," "intends," "estimate,""anticipate," "plan," "predict," "probable," "potential," "possible,""should," "continue," and other words of similar meaning. Actual results coulddiffer materially from the expectations contained in forward-lookingstatements as a result of several factors, including regulatory approvalrequirements and competitive conditions. These and other factors that mayresult in differences are discussed in greater detail in the company's reportson Forms 10-K, 10-Q, and other filings with the Securities and ExchangeCommission.Halozyme Contact Media Contacts Robert H. Uhl Karen Sparks / Joleen Schultz Senior Director, Investor Relations Mentus (858) 704-8264 (858) 455-5500, x275/x215 email@example.com firstname.lastname@example.org email@example.com
SOURCE Halozyme Therapeutics, Inc.