WASHINGTON (dpa-AFX) - Providing an update on the clinical trial programs of lead investigational drug tesetaxel, biopharmaceutical firm Genta Inc. (GNTA.OB) Wednesday said that safety results for the drug in the treatment of breast cancer are consistent with prior studies, with more than 50 percent major response rate. The company also plans for a Special Protocol Assessment submission with the U.S. FDA for the tesetaxel study in advanced gastric cancer.
Genta's Chairman and CEO Raymond Warrell, Jr. announced these at the 2011 BIO International Business Forum in Washington, D.C.
Tesetaxel is being tested in seven ongoing or planned clinical trials, including for the treatments of breast and gastric cancers.
Unlike standard taxanes, tesetaxel is an oral capsule. Preclinical and clinical data show that the drug, when compared with standard agents, is active in diseases that are resistant to standard taxanes.
According to the company, in the breast cancer study, the drug's major response rate in evaluable patients continues to exceed 50 percent to date. Patient number has been accrued by 21.
Based on the favorable data, the company expects to expand the initial cohort treated on the once-every-3-weeks dosing schedule to 40 patients from 25. The company also plans for a protocol amendment to evaluate the drug's dosing on an alternate schedule i.e., once weekly for 3 consecutive weeks after the dose has been identified from an ongoing study.
Further, Genta said that it plans to submit a request with the U.S. FDA for a Special Protocol Assessment of its planned phase 3 trial of tesetaxel as second line therapy in advanced gastric cancer patients in the third quarter of 2011. The protocol has completed the scientific advice process at the European Medicines Agency and is currently under review at other global regulatory authorities.
The company also stated that it will expand the confirmatory phase 2b study of tesetaxel as second line treatment for advanced gastric cancer into Asia. The study is now open in the U.S.
In the study of tesetaxel as first line therapy for gastric cancer, safety results are consistent with prior reports, Genta noted. The trial is currently accruing patients at the second dose level. Upon completion of the first phase, the study will expand to an extended multinational trial in approximately 48 patients.
Additionally, the company has completed patient accrual for a second, U.S.-based, confirmatory safety study of tesetaxel plus capecitabine in patients with advanced cancer. These study results will be submitted to FDA as part of the SPA.
Genta is also accruing patients for dose-ranging studies of tesetaxel in Japanese subjects. Upon determination of the maximum tolerated dose level, the company will evaluate the activity and safety of tesetaxel in patients with breast cancer.
BIO represents over 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the U.S. and in more than 30 other nations.
GNTA.OB is trading at $0.0250, up $0.0011 or 4.60 percent, on a volume of 2.22 million shares.
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© 2011 AFX News
