Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Phase 3 Study Of Subcu Pertuzumab And Trastuzumab Initiated Using Halozyme's ENHANZE® Technology

Today : Thursday 26 July 2018

SAN DIEGO, July 26, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's proprietary ENHANZE® drug-delivery technology in combination with chemotherapy.

The global Phase 3 study is investigating the combination as a single fixed-dose in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant and adjuvant settings. The estimated administration time for the initial loading dose of the combination is 7 to 8 minutes and subsequent maintenance doses are approximately 5 minutes.

"We are excited to support the initiation by Genentech of the first Phase 3 study exploring a fixed-dose combination of two therapeutics," said Dr. Helen Torley, president and CEO of Halozyme. "For breast cancer patients and healthcare professionals, the approach of administering pertuzumab and trastuzumab subcutaneously in a single injection with ENHANZE offers the potential for a new treatment administration option."

The Phase 3 study follows a Phase 1b clinical trial that assessed the safety, tolerability and pharmacokinetics of the same fixed-dose combination presented at the 2017 San Antonio Breast Cancer Symposium.