Xcyte Therapies Presents Results of Two Clinical Trials of Xcellerated T Cells

Xcyte Therapies has presented results from two clinical trials of Xcellerated T Cells, including data from a Phase I/II study of Xcellerated T Cells after autologous peripheral blood stem-cell transplantation in patients with multiple myeloma, and preliminary results from a Phase II study of Xcellerated T Cells in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL).

In the Phase I/II clinical trial in multiple myeloma, 36 patients were treated with a single infusion of Xcellerated T Cells three days following high-dose chemotherapy and autologous stem-cell transplantation. Recovery of lymphocytes and T cells was much more rapid than previously seen in patients treated with the same therapeutic regimen without receiving Xcellerated T Cells. Response data are available for 35 patients, with a median follow-up of 13 months. Thirty-one patients had a significant tumor response, as measured by a 50 percent or greater decrease in the serum M-protein, a standard biological marker for multiple myeloma. A 90 percent or greater decrease in the serum M-protein was seen in 21 of the patients, including three patients with complete disappearance of the marker. Progression-free survival was 67 percent at one year and 58 percent at two years by Kaplan-Meier analysis. Thirty-four of the 36 treated patients are currently alive.

In the Phase II clinical trial in NHL, 27 of a planned 40 patients with small lymphocytic, mantle cell, marginal zone and follicular cell lymphoma have been enrolled. Patients received two infusions of Xcellerated T Cells separated by six to eight weeks. The infusions were well-tolerated and no serious adverse events related to therapy were reported in the 11 patients for whom data are available. Sustained increases in T-cell counts were observed in treated patients. Early response results are available for 16 patients, 11 after one infusion and five after two infusions of Xcellerated T Cells. One patient had an unconfirmed complete response pending a bone marrow biopsy, 13 patients had stable disease, including two minor responses, and two patients had progressive disease.