The US Food & Drug Administration has accepted the New Drug Application filed by Tau Therapeutics LLC for the company's novel oncology product mibefradil.
Mibefradil is actually an older drug used in humans for hypertension and a drug with a well-known safety profile. Tau repositioned mibefradil as an anti-cancer drug when used as a platform for a T-type calcium channel inhibitor, and this is how they will be putting the drug through clinical trials.
They will begin with a Phase I study in healthy patients, followed by a Phase Ib cancer clinical trial in concert with the National Cancer Institute.
In pre-clinical tests, Tau believes the drug in its proprietary version has demonstrated pre-clinical efficacy against solid tumor cancers including brain cancer, pancreatic cancer, breast cancer and ovarian cancer.
Source: Therapeutics Daily
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