Surefire Medical Receives Grant for Clinical Trial Investigating CAR-T Therapy Delivery Using Precision Infusion System

November 15, 2016—Surefire Medical, Inc. has announced that it has received a grant from the Colorado Office of Economic Development and International Trade to commence HITM-SURE, a phase 1b immunotherapy clinical trial for patients with liver cancer metastases. The purpose of the study is to investigate the use of Surefire's Precision infusion system to deliver chimeric antigen receptor T-cells (CAR-T) directly to liver metastases. The clinical trial is a collaboration between Surefire Medical, the Roger Williams Medical Center, and the University of Colorado School of Medicine.

CAR-T therapy has shown encouraging results for the treatment of certain hematologic malignancies. However, the systemic administration methods used for therapy are often associated with severe adverse effects. The HITM-SURE study will attempt to determine whether precise localized delivery using the Precision infusion system can enable the administration of a therapeutic dose for a product candidate in solid tumor while limiting known systemic side effects of CAR-T treatments.

“Administering CAR-T cells through conventional methods to achieve a therapeutic dose in solid tumor applications is not only inefficient, but also frequently limited by severe systemic side effects, such as neurotoxicity and cytokine release syndrome,” commented Steven Katz, MD, Principal Investigator of the trial and Director of the Office of Therapeutic Development at the Roger Williams Medical Center in Providence, Rhode Island. “We hope to improve the therapeutic window for [CAR-T] treatments by directly administering a smaller but concentrated dose precisely at the tumor site.”

Surefire’s Precision infusion system employs a semiporous expandable tip that increases infusion pressure. A multicenter registry showed that the use of this system to deliver therapy for the treatment of primary liver cancer (hepatocellular carcinoma) was associated with a 68% complete tumor response and a 92% objective tumor response, the company advised.