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news.Genta has presented oral tubulin inhibitor tesetaxel two dose-ranging trials results that showed potential activity in patients with taxane-resistant cancers, along with no evidence of hypersensitivity and a low incidence of nerve damage, both of which are common side effects of standard taxanes.
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Tesetaxel is a late Phase 2 oncology oral taxane product. The data were presented at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Genta’s Tesetaxel clinical study has evaluated two dosing schedules. One is a single dose administered once every 3 weeks; and one dose administered once weekly for 3 consecutive weeks, followed by one week off treatment.
Genta claimed that the trials were the first studies to evaluate Tesetaxel in patients who had progressed on other taxane-containing regimens. Tesetaxel was previously tested in women with 2nd and 3rd-line breast cancer, and the drug showed clinical activity in patients who had not previously received a taxane.
In the current trial, eight patients with advanced breast cancer were treated with Tesetaxel after progression on a median of five prior chemotherapy regimens. Seven of the eight patients had progressed after receiving either one or two taxane-containing regimens.
The study results demostrated that four patients (50%), three of whom had progressed on docetaxel or paclitaxel have achieved and are known to be maintaining prolonged stable disease while receiving oral tesetaxel. Other diseases associated with extended stable disease included one patient each with melanoma, nasopharyngeal cancer and non small cell lung cancer.
Raymond Warrell, CEO of Genta, said: “Taxanes have been effectively used in ‘dose-dense’ chemotherapy programs, and these schedules appear to be superior in women with advanced breast cancer.
“Our prior Phase 2a study in patients with 2nd-and 3rd-line breast cancer yielded a 38% objective response rate. The new clinical results suggest confirmation of preclinical data that tesetaxel can overcome standard mechanisms of clinically acquired resistance to standard taxanes.”