Roche initiates study into infusion-free administration of MabThera

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the initiation of a phase III study to investigate a subcutaneous formulation of MabThera (rituximab) for patients with CD20+ non-Hodgkin’s lymphoma (NHL). The Halozyme Therapeutics, Inc. (Nasdaq: HALO) 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 (cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or cyclophosphamide, vincristine and prednisolone (CVP) in patients with previously untreated follicular NHL, followed by maintenance with MabThera alone.

About subcutaneous delivery

Subcutaneous delivery of large biologics uses a recombinant human enzyme (rHuPH20) 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.

About non-Hodgkin’s lymphoma and follicular lymphoma

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 (usually B-lymphocytes) can grow in many parts of the body, including the lymph nodes, spleen, bone marrow, blood and other organs.

Follicular lymphoma (FL) 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(i), and FL accounts for about one in five of these cases. FL affects both men and women and can occur at any time during adulthood, though people are typically diagnosed during their fifties and sixties.

About MabThera/Rituxan

MabThera/Rituxan is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera/Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the EU under the trade name MabThera in June 1998. Over 2.1 million patient exposures with Rituxan/MabThera have been recorded worldwide since launch, 2.0 million in haematological malignancies.

MabThera is known as Rituxan in the United States, Japan and Canada. Genentech and Biogen Idec collaborate on Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.