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news.The FDA has accepted Tau Therapeutics' investigational new drug application (IND 109196) for its novel drug mibefradil.
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The company is expected to initiate a Phase I trial with mibefradil in normal healthy volunteers on 2 March 2012.
The company will also initiate Phase Ib trial of a T-type calcium channel blocker with mibefradil in conjunction with the National Cancer Institute’s Adult Brain Tumor Consortium in patients with recurrent high-grade glioma.
Mibefradil has been used extensively in humans as a hypertension drug and has a well-known safety profile, the company said.
Tau president and CEO Andrew Krouse said Mibefradil represents a new platform of T-type calcium channel inhibition which offers the promise for treating some of the most serious forms of cancer.