Rigel Pharmaceuticals has announced the enrollment of the first patient in a Phase II, multi-center clinical trial of R788 in patients with refractory or relapsed peripheral T-cell lymphoma.
The clinical trial’s primary objective is to assess the efficacy of R788, an orally bio-available Syk kinase inhibitor, in patients suffering from this subset of non-Hodgkin’s lymphoma that originates in the patient’s T-cells. Prior studies have suggested increased expression of Syk at the cellular level in many of these patients with peripheral T-cell lymphoma (PTCL).
The Phase II 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 eight 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 eight 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.
Elliott Grossbard, executive vice president and chief medical officer of Rigel, said: Since we have seen that R788 shows clinical therapeutic benefit in certain types of B-cell lymphomas and that Syk kinase appears to play an important role in certain PTCLs, we believe that R788 may offer new hope to the 12-15% of non-Hodgkin’s lymphoma patients with the T-cell variety.