Cavion is offering the opportunity to license the first small-molecule Cav3 blocker for the treatment of brain and solid tumors through its novel mechanism of action. Mibefradil is Phase 2 ready for a glioblastoma clinical trial. It has an open IND and drug supply is available. Mibefradil is orphan-designated in glioblastoma, ovary and pancreas cancers. Cavion discovered that the T-type calcium channel (Cav3) is essential for external calcium entry in cancer cells. Inhibition of Cav3 hampers a cancer cell’s ability to repair double-strand DNA breaks and causes cancer cell cycle arrest and apoptosis.
This Phase 1 trial was based at Yale University and run in partnership with Cavion. This was a dose-escalation study to assess the safety and determine the maximum tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium channel blocker, combined with hypofractionated radiation therapy in subjects with recurrent glioblastoma multiforme (GBM). For more information, please visit the trial page at ClinicalTrials.gov.
This Phase 1 study at six Adult Brain Tumor Consortium sites completed enrollment in 2014. Preliminary results were presented at the Annual Society of Clinical Oncology Annual Meeting in Chicago in June 2015. Those results can be viewed here. More information on the trial can be viewed at the trial page at ClinicalTrials.gov.
The objective of the study was to determine the safety and pharmacokinetics of a 7-day course of oral mibefradil given four times a day in healthy volunteers. This was a dose escalation study in which the total daily dose of mibefradil was increased with each cohort. More information can be found on the trial page at ClinicalTrials.gov.