Genta pulls Genasense NDA, restructures

GNTA withdrew its NDA for Genasense to treat advanced melanoma. The move follows a 13-3 vote by an FDA panel that the results of GNTA's Phase III trial of Genasense plus dacarbazine (DTIC) versus DTIC alone did not provide substantial evidence of effectiveness (see BioCentury, May 10, 2004). GNTA said it has requested a meeting with FDA to discuss the next steps for the melanoma indication.

In addition, GNTA will reduce its headcount by 45% in order to focus on Genasense and conserve cash. The company said the move will give it time to collect and analyze data from other Genasense trials. GNTA also will stop marketing its Ganite gallium nitrate injection to treat cancer-related hypercalcemia that is resistant to hydration. The company said it could not sustain the marketing and selling expenses necessary for Ganite to reach profitability. ...