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Phase 1/2 Trial of Motexafin Gadolinium Plus Antibody Targeted Radiation Therapy Demonstrates High Complete Response Rate in Patients With Non-Hodgkin's Lymphoma
Date:6/5/2008

SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced final data from a Phase 1/2 study showing a 46 percent complete response rate in patients with multiply recurrent non-Hodgkin's lymphoma (NHL) who were treated with motexafin gadolinium (MGd, Xcytrin(R)) in combination with Yttrium-90 Ibritumomab Tiuxetan (Zevalin(TM)), an approved antibody-targeted radiation therapy. The data were presented during the 10th International Conference on Malignant Lymphoma being held this week in Lugano, Switzerland.

The Phase 1/2 study was conducted in 29 patients with advanced relapsed lymphomas, including 11 patients with aggressive lymphomas. Eighty-three percent of the patients were rituximab (Rituxan(R)) refractory. Patients were treated with a standard dose of Zevalin administered with 2.5 to 5.0 mg/kg of MGd given for six days. Of 28 evaluable patients, 46 percent showed a complete response and 11 percent showed a partial response for an overall response rate of 57 percent. Rituximab refractory patients showed an overall response rate of 86 percent, with a 64 percent complete response rate and a median time to progression of 14 months. Adverse events seen were related to bone marrow suppression, an expected side effect of treatment with Zevalin.

"Motexafin gadolinium has been shown to have single agent activity in lymphoma and is synergistic with radiation therapy. This study shows a high rate of durable complete responses, especially in rituximab refractory patients," said Andrew M. Evens, D.O., M.S., Department of Hematology/Oncology, Northwestern University Feinberg School of Medicine, and lead author of the study.

Pharmacyclics has been developing MGd for use in combination
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SOURCE Pharmacyclics, Inc.
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