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Phase 2 Results of Rigel's R788 Show Clinical Benefit in Diffuse Large B-Cell Lymphoma and CLL
Date:12/7/2008

with Lymphoplasmacytic NHL and 3 with MALT/MZL. The 4 patients with Lymphoplasmacytic and MALT are not referenced in the above table as they did not show a response to treatment.

Clinical Trial Design

This clinical trial was conducted in two Phases. Phase 1 included a small group of patients and resulted in the selection of the dosing regimen employed in Phase 2. Nearly equal numbers of patients were enrolled in the three Phase 2 groups that included, respectively: DLBCL, follicular lymphoma (FL) and other non-Hodgkin's lymphomas (specifically CLL/SLL, MCL, MALT, marginal zone, and lymphoplasmacytic). Prior to enrollment in the R788 trial, all patients enrolled in the clinical trial had received various standard-of-care treatments for their disease, including combination chemotherapy, and had failed to respond to those therapies or suffered a relapse of the disease. A total of 68 patients received 200 mg PO bid (orally, twice daily) of R788 until disease progression occurred. Response to treatment was evaluated using standard NHL response criteria (The Cheson Criteria). Treatment-related adverse events included cytopenias, fatigue, diarrhea/abdominal discomfort and hypertension. Most adverse events were mild to moderate and were reversible. Four patients are continuing to receive R788, including 2 from the CLL/SLL group and 1 from the DLBCL group.

B-Cell Lymphoma and Syk Inhibition

Lymphoma affects an estimated 500,000 people in the United States, with 332,000 of them suffering from non-Hodgkin's lymphoma. Diffuse large B-cell lymphoma is the most common type of NHL and is generally categorized as aggressive, marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow and other organs. A variety of treatment options for NHL exist, including chemotherapy and radiation, but the five-year survival rate for NHL patients is estimated to be a
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SOURCE Rigel
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