This dose escalation trial will evaluate the safety andpharmacokinetics of mibefradil when sequentially administered with temozolomide—anovel proprietary approach Tau calls Interlaced Therapy which has the potentialto synchronize the division of tumor cells and thereby significantly increasetheir sensitivity to subsequent treatment with chemotherapy.
"The ABTC has chosen to collaborate with Tau becauseInterlaced Therapy nicely fits with the primary objective of our consortium—totest promising new approaches for the treatment of glioblastoma," said Dr.Stuart A. Grossman, co-director of the ABTC. "We look forward to the valuableinformation this trial will provide."
"This Phase Ib study is the first step toward developingT-type calcium channel blockers as a new class of compounds for the treatmentof cancer," said Dr. Lloyd S. Gray, vice president of scientific discovery atTau Therapeutics. "When used in Interlaced Therapy, we believe that mibefradiland other T-type calcium channel inhibitors will amplify the cancer-killingeffect of current chemotherapies, thereby offering an improvement over standardtreatments."
The trial will commence at several ABTC sites, includingJohns Hopkins University, Henry Ford Health System, Emory University,University of Pennsylvania, University of Pittsburgh and Wake ForestUniversity.
Once the maximum tolerated dose of mibefradil is determined,additional patients will be recruited in a dose-expansion cohort to ensuresafety and measure the effect of mibefradil on tumor metabolism as demonstratedby F-18 FLT PET scans. This trial is the first to evaluate the use of F-18 FLTPET scanning in brain cancer.
Tau plans to present the results of the Phase Ib trial in2013.
