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news.Genta, a biopharmaceutical company, has submitted a proposal to the FDA for a randomized clinical trial of tesetaxel, an oral taxane chemotherapy compound, for special protocol assessment.
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A special protocol assessment is intended to secure agreement on the design, size and endpoints of clinical trials that are intended to form the primary basis of an efficacy claim in a new drug application. Genta also expects to seek scientific advice from the European Medicines Agency for this study to support a marketing authorization application. The company believes tesetaxel is the leading oral taxane currently in clinical development.
The proposed protocol will examine the safety and efficacy of tesetaxel in patients with advanced gastric cancer whose disease has progressed after receiving first-line chemotherapy. Further details of the study will be announced after a final agreement is secured with both regulatory agencies, the company said. The FDA has previously granted orphan drug designation to tesetaxel for the treatment of patients with advanced gastric cancer.
Tesetaxel is an orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. 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, the company said.