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www.fdanews.com/articles/73345-genasense-plus-rituximab-reported-active-in-patients-with-relapsed-nhl

Genasense Plus Rituximab Reported Active in Patients With Relapsed NHL

June 14, 2005

Genta has announced the presentation of clinical data reporting the safety and activity of Genasense injection, the company's lead anticancer drug, in combination with rituximab.

The trial was conducted in patients with relapsed and refractory non-Hodgkin's lymphoma by investigators from the M.D. Anderson Cancer Center, Houston; McMaster University, Hamilton, Ontario; and the Fox Chase Cancer Center, Philadelphia.

In this study, Genasense (oblimersen sodium) was administered daily for seven days on Weeks 1, 3 and 5, and rituximab was administered weekly for six weeks. Thirty-five patients who had failed a median of two prior chemotherapy regimens with or without rituximab were entered into this ongoing trial.

To date, six patients have achieved a complete response, one of whom was refractory to prior rituximab therapy. Nine other patients have achieved a partial response for an overall response rate of 42 percent. Patients with the specific subset of follicular lymphoma showed a response rate of 56 percent. Twelve other patients have had stable disease. Side effects of the combination appeared qualitatively similar to that for rituximab alone, including but not limited to neutropenia, fever, infection, anemia and fatigue.