The US National Cancer Institute Awards 5-year Grant to Fund Clinical Trial Using Cell Sense Technology in Patients with Head and Neck Cancers
July 3, 2017 – Pittsburgh, Pennsylvania
The National Cancer Institute (NCI), a branch of the US National Institutes of Health, has awarded a 5-year grant to fund research into the trafficking of an anti-cancer cellular immunotherapy product, tumor infiltrating lymphocytes (TILs), in head and neck cancer (HNC) patients. In this study, the TILs administered to patients will be labeled with Cell Sense CS-1000, an MRI tracer agent manufactured by Celsense, Inc., rendering the cells visible using magnetic resonance imaging (MRI). The MRI results will be used to measure homing and persistence of TILs at disease sites following administration to the patient.
The Principal Investigators for this research project are Eric T. Ahrens, Ph.D., Professor of Radiology at the UC San Diego, and Ezra Cohen, MD, Professor of Medicine at UC San Diego and Associate Director of the Moores Cancer Center in La Jolla, California.
This is a clinical exploratory project to visualize the biodistribution and cell survival of TILs in patients with HNC. TILs are derived by harvesting endogenous cancer-killing lymphocytes (white blood cells) that reside at a patient’s tumor site. The lymphocytes are expanded externally in tissue culture to large numbers and then re-administered to the patient. In the funded study, different cohorts of patients will receive TILs alone, or TILs with a co-therapy called a checkpoint blockade.
HNC is the sixth most common cancer worldwide. In the United States, HNC accounts for 3% (55,000 cases in 2015) of all cancers diagnosed annually and 2% of cancer related deaths. There is also a poor prognosis for patients with reoccurrence, with a mean survival of less than 2 months. Immunotherapy is emerging as a key anti-cancer strategy with the potential to provide patient-specific, less toxic and more efficacious treatments. TILs have proven successful in melanoma, and a major effort is underway at UC San Diego to develop this therapy for HNC.
“Although TIL therapies have been used in hundreds of patients to date, fundamental questions remain about the modes of action of TILs in vivo. Up until now, we have been blind to the behavior of cells after infusion into patients. TIL trafficking, as well as cell survival, may be predictive of responders versus non-responders to treatment. Surrogate biomarkers in this field are badly needed,” according to Dr. Ahrens.
“We are excited about this opportunity to work with Drs. Ahrens and Cohen. The Cell Sense MRI cell tracking data may reveal important information about T cell tumor homing, cell survival, and the effect of co-therapies,” said Charlie O’Hanlon, President and CEO of Celsense, Inc.
About Celsense, Inc.
Celsense, Inc. develops and offers novel product that enable the non-invasive imaging of cells in vivo using magnetic resonance imaging (MRI). The company’s lead product Cell Sense CS-1000 is a patented fluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Cell Sense CS-1000 is the subject of a Drug Master File at US FDA and Health Canada, and is the only clinical grade MRI cell tracking reagent available in North America. Using software developed by Celsense, investigators can quantify the number of labeled cells in a user-specified region of interest. Celsense’s mission is to be the standard for cellular imaging in human health.
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Celsense offers products that enable real-time MRI detection of inflammation and cellular therapeutics. The mission of the company is to be the standard for cellular imaging in human health.
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