Genta Submits Randomized Study of Tesetaxel in Patients with Advanced Gastric Cancer to FDA for Special Protocol Assessment
Wednesday February 11, 8:05 am ET
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GNTA - News) announced today that the Company has submitted a proposal to the Food and Drug Administration for a randomized clinical trial of tesetaxel, an oral taxane chemotherapy compound, for Special Protocol Assessment (SPA). A SPA 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 (NDA). Genta also expects to seek Scientific Advice from the European Medicines Agency (EMEA) for this study to support a Marketing Authorization Application (MAA). 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 final agreement is secured with both regulatory agencies. FDA has previously granted Orphan Drug designation to tesetaxel for treatment of patients with advanced gastric cancer
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. 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 (low blood counts) and peripheral neuropathy (disabling nerve damage).
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.
Tesetaxel has demonstrated anticancer activity in several Phase 2 clinical trials. The drug has not been associated with severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 250 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
Tesetaxel in Advanced Gastric Cancer
In the completed Phase 2 study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine (Xeloda®; Hoffmann-La Roche, Inc.), and all but 2 patients had received a third chemotherapy drug with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients. Six patients failed to complete the first course of treatment. Five patients died on study from differing causes that included intestinal perforation, pneumonia, hepatic failure, hemorrhagic shock, and rapid disease progression. One patient withdrew before receiving the first treatment dose.
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