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Confirmatory Clinical Trial for Oblimersen Requested by FDA
“While disappointed with this decision, we appreciate FDA’s clarification of the path to U.S. regulatory approval in this important indication,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “The Company will discuss this decision with clinical and regulatory authorities before determining our next steps. Genta greatly appreciates the professional and collaborative communications with FDA during this process, and we look forward to working with FDA in addressing their recommended options for securing the confirmatory data.”
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
Source: Genta Incorporated