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Rigel Commences Phase 2 Trial of R788 in Peripheral T-Cell Lymphomas
Date:3/13/2009

in Peripheral T-Cell Lymphomas Overexpressing Activated Syk" suggested that Syk may play a critical role in some PTCLs and represents a feasible therapeutic target for further clinical study.

Phase 2 Design

The Phase 2 trial will be conducted in two stages at several centers in North America with each patient receiving 200mg of R788 twice a day for a minimum of 8 weeks, or until disease progression or withdrawal from the trial. During stage one, 19 men and women with PTCL who have previously failed to respond to standard of care treatment for their disease are expected to be evaluated. Stage two is expected to include the enrollment of approximately 36 patients. Efficacy will be assessed by CT/PET scans at baseline and CT scans of the disease-involved areas at 8 weeks. Safety will be assessed by periodic physical exams, blood tests and clinical laboratory work, among others. Results of the clinical trial are expected in the second half of 2010.

In June 2008, Rigel first reported results of a Phase 2 clinical trial of R788 in the treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphomas. R788 was well-tolerated in this patient population and showed therapeutic benefit in patients suffering from certain subcategories of the disease, especially small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL) and diffuse large B-cell lymphoma. More details about the outcome of that clinical trial and the role that Syk inhibition may play in the treatment of lymphoma patients can be found at Rigel's website, http://www.rigel.com/rigel/lymphoma.

About Rigel

Rigel is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory/autoimmune diseases and metabolic diseases. Our pioneering research focuses on intrace
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SOURCE Rigel Pharmaceuticals, Inc.
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