Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabeti...( SAN DIEGO Nov. 3 /- Halozyme Ther...)

SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), 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 stan
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