WASHINGTON (dpa-AFX) - Genta Incorporated (GNTA.OB) provided a comprehensive update of its clinical trials programs with the company's investigational drug tesetaxel. The information was presented by Genta's Chairman and Chief Executive, Raymond Warrell, Jr., at the 2011 BIO International Business Forum in Washington, D.C., the world's premier partnering meeting.
The company plans to submit a request for Special Protocol Assessment or SPA of its planned Phase 3 trial of tesetaxel as 2nd-line therapy in patients with advanced gastric cancer to the U.S. FDA in the third quarter of 2011.
The confirmatory Phase 2b study of tesetaxel as 2nd-line treatment for patients with advanced gastric cancer, which is currently open in the U.S., would be expanded into Asia with opening of a leading Korean cancer center in the 2011 third quarter.
Accrual to a study in 1st-line gastric cancer has been completed at the initial dose level. To date, safety results are consistent with prior reports for the drugs used alone. The trial is currently accruing patients at the second dose level. This dose-finding phase is expected to enroll 12-15 patients. Following the first phase completion, the study would expand to an extended multinational trial in about 48 patients. This trial is expected to be a 'run-in' study for a planned Phase 3 trial in previously untreated patients with advanced gastric cancer.
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© 2011 AFX News
