On December 4, 2013 3-V Biosciences reported the recent initiation of a Phase 1 clinical study of TVB-2640 in patients with advanced solid tumors (Press release 3-V Biosciences, DEC 4, 2013, View Source [SID:1234500430]). TVB-2640 is an oral, proprietary fatty acid synthase (FASN) inhibitor being evaluated for the treatment of solid tumors. FASN is an enzyme responsible for the synthesis of palmitic acid and has a key role in tumor metabolism, lipid signaling and tumor cell survival.
The Phase 1 open-label, dose-escalation trial will enroll patients with advanced solid tumors whose cancer has become refractory to standard therapy, and for whom no useful treatment exists. Patients will receive TVB-2640 once daily for 21 days. The primary endpoint for the Phase 1 study is the identification of any dose-limiting toxicities and the establishment of a maximum- tolerated dose (MTD) for oral TVB-2640. Secondary and exploratory endpoints include safety, pharmacokinetics, and initial signs of efficacy and evidence of FASN biomarker activity.
FASN over-expression is associated with aggressive disease and poor prognosis in a number of cancers. In a series of preclinical studies, 3-V’s FASN inhibitors demonstrated potent activity against multiple tumor types, including breast, lung, pancreatic, ovarian and colon cancers. FASN inhibition reduced cell proliferation and induced apoptosis (cell death) in a dose-dependent manner and single-agent FASN inhibition both blocked tumor growth and resulted in significant tumor regression in patient-derived xenografts. In addition, 3-V has demonstrated potential synergy of its FASN inhibitors with cytotoxic agents.
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