Tau Therapeutics Completes Phase 1 Clinical Trial of Mibefradil for Use in Oncology

Confirms Target Dose for Phase 1b Development

JPMorgan Healthcare Conference 2013

CHARLOTTESVILLE, Va.--()--JPMorgan Healthcare Conference

Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for use in the treatment of solid tumors, announced today that it has completed a Phase 1 trial in normal healthy volunteers with its novel repositioned drug for use in cancer therapy, mibefradil. The 30-patient dose escalation trial evaluated the detailed pharmacokinetics of mibefradil administered four times a day and confirmed its safe dose levels for use in a Phase 1b trial. Tau concluded the trial prior to reaching a dose limiting toxicity when pharmacokinetic data demonstrated that the study reached plasma concentrations of mibefradil in humans equal to the concentrations found to be effective in pre-clinical xenograft models.

“These results are important because they confirm that at the target dose mibefradil is an excellent product candidate for cancer treatment with a known low side-effect profile from prior clinical use in other indications,” said Dr. Lloyd S. Gray, Vice President of Scientific Discovery, “We believe Tau’s unique mechanism of action will provide new opportunities for well-tolerated cancer treatment regimens with increased efficacy.”

The Phase 1 safety and pharmacokinetic data is currently informing a Phase 1b dose escalation trial of Interlaced Therapy™, the administration of mibefradil prior to chemotherapy. The Phase 1b trial is being conducted with the NCI’s Adult Brain Tumor Consortium in patients with recurrent high-grade glioma. Interlaced Therapy™ with mibefradil has demonstrated pre-clinical efficacy in a variety of solid tumors, including brain, pancreatic, ovarian, and breast cancers.

About Mibefradil

Mibefradil, the company’s first product candidate to enter clinical trials, has been used extensively in humans for hypertension and has a well-known safety profile. Tau Therapeutics has repositioned mibefradil for use with traditional chemotherapeutic agents in solid tumors.

About Tau Therapeutics LLC

Tau Therapeutics, a privately held oncology company based in Charlottesville, VA, is at the forefront of cancer research focusing on controlling the proliferation pathway rather than a specific protein or growth factor. Tau’s Interlaced Therapy™ is built on the rationale that using a T-type calcium channel inhibitor to increase the proportion of cancer cells and cancer stem cells at the point of maximum metabolic vulnerability in S phase will increase cell death caused by cytotoxic chemotherapies. By more effectively reducing tumor burden and killing the cells that cause recurrence, Tau believes it will offer a significant advancement in the treatment of cancer.

Forward-Looking Statement

This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Tau Therapeutics LLC disclaims any intent or obligation to update forward-looking statements, except as required by law.

Contacts

Tau Therapeutics LLC
Andrew Krouse, 434-974-6969
krouse@tautherapeutics.com
www.tautherapeutics.com

Release Summary

Tau Therapeutics completed a normal healthy volunteer dose escalation trial of its T-type calcium channel inhibitor mibefradil to evaluate PK and confirm safe dose levels for a Phase 1b cancer trial.

Contacts

Tau Therapeutics LLC
Andrew Krouse, 434-974-6969
krouse@tautherapeutics.com
www.tautherapeutics.com