Phase 1 study of GenSpera for the treatment of breast cancer

GenSpera announced the FDA approval of its Investigational New Drug (IND) application to begin a Phase 1 study of its pro-drug, G-202 for the treatment of various cancers, including breast cancer.  This study is designed to enroll patients with cancers that have progressed after treatment with other anti-cancer agents. The primary endpoints of the open-label, dose-escalation study will be to determine the safety, tolerability and pharmacokinetics of the drug, although the design allows the collection of efficacy data as well.

G-202 is a pro-drug that is selectively activated within tumors by an enzyme present on the tumor blood vessels. In preclinical testing, G-202 was shown to ablate tumors in animal models of breast cancer, prostate cancer and kidney cancer. G-202 targets the established blood vessels that nourish solid tumors, thus destroying the tumor’s blood supply, unlike current anti-angiogenic drugs that primarily only stop the growth of new blood vessels.  

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