Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors, announced today that its investigational new drug application (IND 109196) for its novel drug mibefradil has been accepted by the Food and Drug Administration (FDA).
The company plans to commence a Phase I trial with mibefradil in normal healthy volunteers on March 2, 2012. The company also plans to initiate the very first Phase Ib cancer clinical 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 in the spring.
"FDA acceptance of our IND is a significant milestone for Tau," said Andrew J. Krouse, President and CEO. "Mibefradil represents not only our lead clinical candidate but also a new platform of T-type calcium channel inhibition which offers the promise for treating some of the most serious forms of cancer."
Mibefradil, the company's first drug to enter clinical trials, has been used extensively in humans as a hypertension drug and has a well-known safety profile. Tau Therapeutics has repositioned mibefradil as an oncology drug for use in solid tumors. When used in the company's proprietary approach Interlaced Therapy™, mibefradil demonstrates excellent pre-clinical efficacy in brain, pancreatic, ovarian, and breast cancers by overcoming chemotherapeutic drug resistance and prolonging lifespan. Research with mibefradil and Interlaced Therapy™ has been conducted at Duke University's Preston Robert Tisch Brain Tumor Center, the University of Virginia Cancer Center, Johns Hopkins' Sidney Kimmel Cancer Center, and Tulane University Cancer Center.