Roche Holding AG (ROG.VX) Wednesday said it has started a phase III study to investigate a subcutaneous formulation of MabThera (rituximab) for patients with CD20+ non-Hodgkin's lymphoma.

Main Facts:

--The Halozyme Therapeutics, Inc. proprietary Enhanze technology allows the administration of MabThera in people diagnosed with NHL via a subcutaneous injection in a much shorter timeframe than the current intravenous administration.

--The trial is an international, multi-center, randomized, controlled, open-label two-stage phase III study that will investigate the pharmacokinetics, efficacy and safety of subcutaneous rituximab in combination with chemotherapy, followed by maintenance with MabThera alone.

--Subcutaneous delivery of large biologics uses a recombinant human enzyme that reversibly breaks down hyaluronan, a gel-like substance that forms a barrier in the interstitial tissue. When this enzyme is combined or co-formulated with certain injectable drugs, it allows easier absorption and dispersion of larger molecules and larger fluid volumes by temporarily clearing a path through the connective tissue of the skin.

--Administering a highly concentrated subcutaneous MabThera formulation via bolus injection will take less than 10 minutes.

--Non-Hodgkin's lymphoma (NHL) is a cancer of the lymphatic system, a vital part of the immune system, that is caused when lymphocyte production goes wrong and creates a malignant cell that replicates at high speed and does not respond to normal physiological controls. Such cancerous lymphocytes can grow in many parts of the body, including the lymph nodes, spleen, bone marrow, blood and other organs.

Follicular lymphoma is a common subtype of NHL which is slow-growing and is characterized by periods of relapse and remission. Unfortunately, FL remains incurable. Despite substantial progress, patients ultimately relapse and require additional treatments. Approximately 356,000 people worldwide are diagnosed with NHL each year, and FL accounts for about one in five of these cases.

-Zurich Bureau, Dow Jones Newswires; +41 43 443 8040; zurichdjnews@dowjones.com
Halozyme Therapeutics (NASDAQ:HALO)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Halozyme Therapeutics Charts.
Halozyme Therapeutics (NASDAQ:HALO)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Halozyme Therapeutics Charts.