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Tau Therapeutics and NCI launch Phase Ib trial in brain cancer
July 2012

CHARLOTTESVILLE, Va.—Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors, announced today that it has opened enrollment for a Phase Ib clinical trial with the National Cancer Institute's Adult Brain Tumor Consortium (ABTC) using the company's first product candidate mibefradil. The trial will introduce a new therapeutic approach to patients with recurrent high-grade glioma.  
This dose escalation trial will evaluate the safety and pharmacokinetics of mibefradil when sequentially administered with temozolomide—a novel proprietary approach Tau calls Interlaced Therapy which has the potential to synchronize the division of tumor cells and thereby significantly increase their sensitivity to subsequent treatment with chemotherapy.  
"The ABTC has chosen to collaborate with Tau because Interlaced Therapy nicely fits with the primary objective of our consortium—to test promising new approaches for the treatment of glioblastoma," said Dr. Stuart A. Grossman, co-director of the ABTC. "We look forward to the valuable information this trial will provide."  
"This Phase Ib study is the first step toward developing T-type calcium channel blockers as a new class of compounds for the treatment of cancer," said Dr. Lloyd S. Gray, vice president of scientific discovery at Tau Therapeutics. "When used in Interlaced Therapy, we believe that mibefradil and other T-type calcium channel inhibitors will amplify the cancer-killing effect of current chemotherapies, thereby offering an improvement over standard treatments. "  
The trial will commence at several ABTC sites, including Johns Hopkins University, Henry Ford Health System, Emory University, University of Pennsylvania, University of Pittsburgh and Wake Forest University.  
Once the maximum tolerated dose of mibefradil is determined, additional patients will be recruited in a dose-expansion cohort to ensure safety and measure the effect of mibefradil on tumor metabolism as demonstrated by F-18 FLT PET scans. This trial is the first to evaluate the use of F-18 FLT PET scanning in brain cancer.
Tau plans to present the results of the Phase Ib trial in 2013.  



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