Clinical Studies Expected to Restart in Second Half 2008
Genta Incorporated recently received notification from the FDA that they may resume clinical trials with tesetaxel, a leading oral taxane in Genta’s oncology product portfolio. The notification was made in response to the company’s submission of a complete response to a prior notice from FDA that had placed the drug on “clinical hold”. “We believe tesetaxel may provide an important option for the care of patients with advanced cancer,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “We are very pleased that FDA found that our initial submission addressed their safety concerns by incorporating careful monitoring and supportive care to reduce risks. We have formulated an innovative development strategy that may enable tesetaxel to become the first oral taxane to receive regulatory approval. We look forward to promptly resuming clinical trials in the second half of this year.”
