Charlottesville-based Cavion LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors and neurologic diseases, presented preliminary results from an ongoing multi-site National Cancer Institute Adult Brain Tumor Consortium (ABTC) and Cavion-sponsored Phase 1b clinical trial at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 1. Matthias Holdhoff, MD, PhD of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins discussed this dose escalation trial, completed enrollment in November 2014, evaluates the safety and pharmacokinetics of Cavion’s novel cancer drug mibefradil when sequentially administered with temozolomide in patients with recurrent high-grade glioma.
Dr. Holdhoff’s poster, entitled “Timed-sequential therapy with mibefradil and temozolomide in patients with recurrent high-grade gliomas: A phase I Adult Brain Tumor Consortium study,” concludes that the lack of toxicity and the presence of responses in the selected patient population suggests that the protocol regimen deserves further investigation. Seven ABTC member institutions are participating in the study: Johns Hopkins University, the University of Pennsylvania, Henry Ford Hospital Health System, Emory University, the University of Pittsburgh, the University of Alabama at Birmingham and Wake Forest University.
Dr. Holdhoff, who presented the trial design at ASCO in 2013, noted, “I am pleased to update my colleagues on the progress of the trial and our preliminary observations on mibefradil’s safety in patients with recurrent high-grade glioma.” One of those colleagues, Dr. Burt Nabors, Director of the Division of Neuro-oncology at the University of Alabama at Birmingham, said, “As a member of the ABTC, my institution enrolled five patients, two of whom showed strong clinical responses to the treatment regimen. I find our patients’ responses encouraging and look forward to the continued development of T-type calcium channel blockers for the treatment of brain cancer.”
“These preliminary results support our belief that our innovative T-type calcium channel blockers provide new opportunities for well-tolerated cancer treatment regimens with increased efficacy to help patients with the most aggressive solid tumor cancers,” stated Cavion President and CEO Andrew Krouse. Cavion is planning to conduct a Phase 2 trial of mibefradil in patients newly diagnosed with glioblastoma.