Genta Announces Results From Clinical Trial of Tesetaxel as Initial Chemotherapy for Women With Recurrent Breast Cancer

Orlando, FL 12/9/11 (StreetBeat) -- Genta Incorporated (OTCBB:GNTA.OB) today announced presentation of results from the Company's Phase 2b clinical trial using tesetaxel as initial, single-agent chemotherapy in women with advanced breast cancer. The trial is lead by Memorial Sloan-Kettering Cancer Center, New York, NY, in collaboration with three other U.S. based cancer centers. The data are being presented this week at the CTRC-AACR San Antonio Breast Cancer Symposium. Tesetaxel is the leading oral taxane in clinical development.

This ongoing study targets women who may be hormone-refractory, but previously untreated with chemotherapy for locally advanced or metastatic HER2-negative breast cancer. Prior adjuvant chemotherapy is allowed if the first relapse occurred at least 12 months after the last dose. To date, 33 patients have been accrued. More than 75% of patients had received adjuvant chemotherapy, and more than 50% of those chemotherapy regimens had included a standard injectable taxane. More than 50% had also received local radiotherapy. Approximately two-thirds of patients had progressed on one or more hormonal therapies.

Twenty-four patients are currently evaluable for response. Major objective responses (RECIST) have been observed in 50% of patients, including 1 complete response and 11 partial responses. Six of the 12 major responders have cleared more than 75% of their measurable disease. The disease control rate in this study, which includes major responders and patients with stable disease, is 83%.

Tesetaxel has been generally well-tolerated. The most common adverse effect (any grade) has been fatigue. Neutropenia has been the most common Grade 3-4 adverse event (52%); however, febrile neutropenia occurred in only 2 cases (6%). Consistent with prior studies, no hypersensitivity reactions were observed.

"These data confirm substantial activity for tesetaxel as initial chemotherapy for women with advanced, HER2-negative, breast cancer," said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Based on aggregate data from our multicenter Phase 2 trials, we will be conferring with FDA to identify potential registration strategies for tesetaxel in breast cancer."

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