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Halozyme Announces Positive Results from Roche's Subcutaneous Herceptin Phase 3 Trial
Date:10/17/2011

ients with CD20+ non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL).

About the HannaH trial

HannaH is a Phase III, open-label trial involving 596 women with HER2-positive early breast cancer. The trial was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy (pathologic complete response) and safety of Herceptin SC to that of Herceptin IV.

The trial met its co-primary endpoints that were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the trial the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count) similar to other trials with chemotherapy and Herceptin IV.

About Herceptin subcutaneous delivery

Herceptin SC uses Enhanze™ Technology, developed by Halozyme(R) which enables the injection of large volumes of a medication under the skin (subcutaneous) and enhances pharmacokinetics. It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 people will die of the disease annually.  

In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumour cells. This is known as 'HER2 positivity' and affects approximately 15-20 percent of people with breast cancer.

Halozyme Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze™ technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme
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SOURCE Halozyme Therapeutics, Inc.
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