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A Novel Site-Specific Drug Delivery System for Solid Tumors
Systemic administration of chemotherapy depends on the circulatory system to carry the drug into the tumor and achieve an adequate dose. However, high intratumoral pressure limits the flow of therapy into solid tumors. In fact, it is estimated that no more than 5% of the injected dose extravasates and accumulates in the tumor.
The Surefire® Infusion System (SIS) is a novel site-specific delivery device that is designed to overcome the pressure barriers posed by hostile tumor microenvironment, and increase the therapeutic index of drugs in solid tumors.
To date, over 7,000 SIS procedures have been performed worldwide to deliver a variety of chemotherapy and radiotherapy agents in liver tumors. SIS has also been shown in a few studies to increase dose of therapy in the tumor while protecting healthy tissue.
How the Technology Works
The patent-protected Surefire technology consists of an intravascular catheter with a proprietary valve-like tip. Currently, interventional radiologists place the SIS in the tumor-feeding arteries before infusing therapy through the catheter. During infusion, the expanded tip creates a temporary increase in local pressure above the mean arterial pressure. This in turn generates a favorable pressure gradient that allows therapy to penetrate deep into the tumor. When backflow is present, the valve-like tip expands against the vessel wall, preventing therapy from reaching non-target areas.
The SIS & Immuno-oncology
With its ability to enhance tumor uptake and reduce non-target delivery, the SIS is poised to enable safe administration of immune-oncology (IO) drugs in solid tumors.
The ongoing HITM-SURE trial (NCT02850536) uses the SIS to administer anti-CEA CAR-T cells in liver metastases. The results of this trial will serve as proof of concept for using the SIS to effectively deliver and manage the safety profile of other IO therapies in solid tumors.
The SIS might also significantly reduce the cost of manufacturing these expensive new treatments. With its highly targeted approach, only a small, concentrated dose of the therapy may be needed to treat patients compared to the dose required for systemic administration.
Partnership, Licensing & Collaboration
Surefire Medical, Inc. designs, develops and manufactures the SIS in its ISO 13485 certified facility in Westminster, CO. We work in partnership with companies interested in using the Surefire technology to improve the effectiveness, safety, and differentiation of their products – whether in early phases of development or in the mature stages of the product lifecycle. Surefire owns a strong portfolio of patents that can be applied in a variety of solid tumors, including tumors of the liver, pancreas, kidney, head and neck, and brain. In addition, we also offer our expertise in device design, manufacturing, and regulatory affairs to help tailor Surefire technology to meet your commercial needs.
Posted Date: 7/3/2018
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