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Preliminary Phase 2 Results of R788 in Lymphoma Show Benefit in Diffuse Large B-Cell and SLL/CLL
Date:6/3/2008

10 6 60% 0

(): # patients enrolled

* NE: Non-Evaluable because of withdrawal due to adverse events or

non-compliance with protocol

** Other NHL patients include 10 with SLL/CLL, 8 with Mantle Cell Lymphoma

(MCL), 3 with MALT, and 1 with Lymphoplasmacystic

At two months of therapy, 53 of the 59 patients were evaluated. Five patients (8% of enrolled) were withdrawn due to possibly related adverse events such as cytopenias and diarrhea, and one for non-compliance. Overall, as of January 15th, 44% of patients had been in the trial for over 7 months without progression of disease. The study is continuing and further results over longer periods of treatment will be available later in the year.

Study Design

The study was conducted in two Phases. In Phase 1, a small group of patients were studied and the 200 mg PO bid (oral, twice daily) dose was selected for further study. In Phase 2, 59 patients with B-cell NHL were enrolled and were given R788. Prior to enrollment, all patients had received various standard of care treatments for their disease, including CHOP (a drug combination) and possibly Rituxan, and had failed to respond to those therapies or suffered a relapse of the disease. The median age was 62 years old. Roughly equal numbers of patients were enrolled based on their subtype of lymphoma, which included: DLBCL, follicular lymphoma (FL) and other non-Hodgkin's lymphomas (specifically - SLL/CLL, MCL, MALT, and lymphoplasmacytic).

B-cell Lymphoma and Syk Inhibition

Lymphoma is the name given to a variety of blood cancers that result when lymphocytes, or white blood cells, grow uncontrollably and build up in the lymphatic system and bone marrow giving rise to malignant tumors. The uncontrolled growth is, in part, mediated by the Syk enzyme, which signals the growth/survive mechanism of the aberrant cells. By inhibiting Syk, that signal is curtailed and the
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SOURCE Rigel Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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