Cancer is the 2nd leading cause of death in the United States (US) and accounts for 1 of every 4 deaths. More than 600,000 Americans will die of cancer in 2018, with annual US cancer-care expenditures reaching $156B by 2020, and more than 10M cancer-related deaths occur annually. While chemotherapy is effective, several cancer subtypes (including liver cancer) are associated with a very low 5-year survival rate of less than 20%. In addition, only a small proportion of cancer patients is eligible for tumor resection and organ transplant. Hepatocellular carcinoma is the most common form of primary liver cancer, with over 500,000 new diagnoses each year and a 5-year survival rate of less than 18%. It remains the 6th most common cancer worldwide and the 3rd most common cause of cancer-related deaths. Unlike other cancers, the death rate for liver cancer has increased over the last 30 years. In general, chemotherapeutic treatment has shown limited effectiveness, with response rates less than 20% and survival less than one-year. One of the few options available to those diagnosed with hepatocellular carcinoma is catheter-directed trans-arterial embolization (with and without chemoembolization), which is the gold standard of care for those diagnosed with intermediate- stage carcinoma. However, despite the procedure?s use for over two decades, it remains largely unstandardized, with variations in the size and type of embolizing particles, choice and dose of chemotherapeutic agent, and the time interval between procedures. Though effective, the procedure?s benefit is modest in that the survival improvement is only 4 months, and the treatment is associated with safety concerns, including embolization of unintended territories. The procedure?s efficacy is hampered by the tumor?s complex hemodynamics and tortuous vasculature, resulting in regions which cannot be reliably and thoroughly occluded. It is generally believed that patient outcomes would be improved if physicians could more completely embolize the tumor?s vascular network. If this were achieved, the tumor would be better starved of blood flow and chemotherapeutic agents could be more effectively delivered. UN&UP has developed a breakthrough technology that allows the physician to directly control and improve the delivery of magnetic embolization beads throughout a tumor?s vasculature. By creating unique magnetic embolization beads, which will be safe in an MR environment, and leveraging the company?s patent-pending technology which focuses magnetic fields in a novel way, magnetic embolization beads can be controlled in a way not previously possible. UN&UP?s objective is to provide a technology to hepatocellular carcinoma patients that results in more effective and safer liver tumor embolization. In the Phase I effort, the company will 1) build the prototype magnet assembly, 2) formulate the prototype magnetic embolization beads, 3) assess in vitro model efficacy and MR safety, and 4) assess in vivo efficacy in a rabbit tumor model. An FDA meeting in planned is advance of a Phase II proposal.

Public Health Relevance

UN&UP is developing a technology that allows physicians to directly control the delivery of magnetic embolization beads throughout a tumor?s vasculature to starve the tumor of its blood supply, and ultimately, to deliver chemotherapeutic agents. Hepatocellular carcinoma is the most common form of primary liver cancer and represents the 6th most common cancer worldwide and the 3rd most common cause of cancer-related deaths, with over 500,000 new diagnoses each year. By leveraging its break-through technology, UN&UP hopes to greatly improve upon the proven benefit of trans-arterial embolization and offer a commercially- superior therapy for those diagnosed with hepatocellular carcinoma.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43CA236083-01
Application #
9680693
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Zhao, Ming
Project Start
2019-03-01
Project End
2020-02-29
Budget Start
2019-03-01
Budget End
2020-02-29
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Unandup, LLC
Department
Type
DUNS #
080999638
City
Saint Louis
State
MO
Country
United States
Zip Code
63110