FDA Lifts Clinical Hold on Genta's Tesetaxel, an Oral Taxane

Genta Incorporated announced that the Company has received notification from the US Food and Drug Administration (FDA) that Genta 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."

About Tesetaxel

Tesetaxel is a novel, orally absorbed, semisynthetic taxane that is in the same class of drugs as paclitaxel and docetaxel (Taxotere). However, both prototype agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side effects of this drug class include myelosuppression and peripheral neuropathy.

With administration as an oral capsule, tesetaxel was developed to maintain the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.