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Phase 2 Clinical Results of Ganite Plus Standard Therapy in,Patients with Relapsed/Refractory Lymphoma Presented at ASCO

BERKELEY HEIGHTS, N.J., June 04, 2007 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of results from a Phase 2 clinical trial of its marketed product, Ganite(R) (gallium nitrate injection), plus rituximab (Rituxan(R); Genentech/IDEC) and dexamethasone in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). The data were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.

Previously published studies have indicated that high doses of gallium nitrate used alone or in combination with chemotherapy showed preliminary evidence of clinical activity in patients with Hodgkin's disease and non- Hodgkin's lymphoma. Based on these data, investigators at Loyola University Medical Center sought to incorporate gallium nitrate into a minimally myelosuppressive "salvage" regimen (called "GaRD") that was designed to treat patients who had failed multiple types of standard therapy.

In the GaRD trial, gallium nitrate was administered in combination with rituximab and dexamethasone. Twenty-two patients with NHL were entered into this study, most of whom had been refractory to multiple salvage therapies. All patients had failed prior treatment with rituximab, including 18 of 22 who received rituximab in their last regimen. Overall, 41% of patients achieved a major objective response, including 8 (36%) with complete or unconfirmed complete responses and 1 (5%) with a partial response. Two of the major responders had previously failed a stem cell transplant; both patients remain in sustained remission 14+ and 18+ months after their last relapse. Six other patients achieved stable disease. Five patients subsequently underwent a stem cell transplant. Of all 22 patients treated with the GaRD regimen, 46% are alive at a median followup of 17+ months, and 7 are currently without evidence of disease.

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