LOS ANGELES--(BUSINESS WIRE)--Surefire Medical, Inc. (Surefire), an oncology drug delivery company, announced today the presentation of data analyzing the efficacy and safety from its national patient registry. The data were presented as part of the 2018 Society for Interventional Radiology (SIR) Annual Meeting in Los Angeles, CA from March 17-22, 2018.
The interim data for the Surefire® Infusion System (SIS) registry included 72 hepatocellular carcinoma (HCC) patients treated with Surefire Pressure-Enabled Delivery (PED) technology enrolled in the registry by June 2017 at 10 leading oncology centers in the United States.
Based on the interim analysis of the data, HCC patients treated with Drug Eluting Beads Transarterial Chemoembolization (DEB-TACE) using SIS for delivery achieved high tumor response rates that are durable up to 6-months based on follow-up. The one-month, three-month and six-month Objective Response Rate (ORR) were 75.3%, 75.1%, and 82.2% respectively. Response rates were not significantly different in tumors <3cm vs. tumors ≥3cm.
“The data from this national patient registry are very consistent with prior single-center studies that demonstrated the use of SIS in DEB-TACE for HCC results in high tumor response rates compared to historical controls. Additionally, these real-world data confirm that SIS can be used safely and effectively across a wide range of HCC patients,” said Jim Chomas, Ph.D., Chief Technology and Oncology Strategy Officer at Surefire.
Details of the abstract and presentation are found here.
Publication authors include:
Dr. Baljendra S. Kapoor – Cleveland Clinic, Cleveland, OH
Dr. Aravind Arepally – Piedmont Healthcare, Atlanta, GA
Dr. Francisco J. Contreras – Florida Hospital, Orlando, FL
Dr. Aaron Fischman – Icahn School of Medicine at Mount Sinai, New York, NY
Dr. Michael Katz – Keck School of Medicine at USC, Los Angeles, CA
Dr. Alexander Y. Kim – Medstar Georgetown University Hospital, Washington, DC
Dr. Steven C. Rose – UCSD Medical Center, San Diego, CA
“Surefire is proud to share results of its ongoing study of Pressure-Enabled Delivery (PED) in HCC. We are committed to generating clinical data that will help refine our understanding of which candidates are most likely to benefit from pressure-enabled delivery and use this knowledge to further improve patient outcomes in solid tumors,” said Mary T. Szela, CEO of Surefire.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the fastest rising cause of cancer related death in the United States and accounts for between 85-90% of primary liver cancers. Worldwide, more than 780,000 new cases of primary liver cancer are diagnosed each year. Because the disease is frequently diagnosed when the cancer has advanced, liver cancers have one of the highest mortality rates with 5-year survival rate of less than 15 percent.
About Pressure-Enabled Delivery (PED)
The high intratumoral pressure created by the tumor microenvironment limits the flow and accumulation of therapy in solid tumors. Interventional medical devices employing Pressure-Enabled Delivery (PED) can improve drug delivery to the tumor by creating a favorable pressure gradient that penetrates the hostile tumor microenvironment and increases drug concentration in the tumor without increasing systemic toxicity. Locoregional infusion with the Surefire-patented technology has been used in more than 7,000 procedures worldwide for liver cancer, and can be applied to a variety of other high-pressure solid tumors.
About Surefire Medical
Surefire Medical is a privately held medical device firm in Westminster, CO, focused on making the administration of cancer therapies safer and more effective for patients. Surefire Medical created the Pressure-Enabled Delivery (PED) technology, and is committed to developing other applications of the technology for use in other solid tumors and for the administration of immuno-oncology (IO) therapies. Surefire Medical was founded in 2011. For more information, visit surefiremedical.com.