FDA Approves Human Trials of Cornell Dots
NEW YORK, June 20, 2011 — The first clinical trial in humans of a new technology called Cornell Dots — brightly glowing nanoparticles that can light up cancer cells in PET-optical imaging — has been approved by the FDA.
The new technology, which was published in the June 13 issue of the Journal of Clinical Investigation, was a collaborative effort between Memorial Sloan-Kettering Cancer Center (MSKCC), Cornell University and Hybrid Silica Technologies (HST), a Cornell business startup.
For the first time, scientists have reported an advanced, comprehensive characterization of Cornell Dots, which was recently approved as an “investigational new drug” (IND) by the FDA for a first-in-human clinical trial, said Michelle S. Bradbury, M.D., of MSKCC and an assistant professor of radiology at Weill Cornell Medical College.
Cornell Dots are silica spheres less than 8 nm in diameter. They enclose several dye molecules. The dots’ silica shell is chemically inert and small enough to pass through the body and out in the urine. For clinical applications, the dots are coated with polyethylene glycol (PEG) so that the body does not recognize them as foreign objects.
To make the dots stick to tumor cells, organic molecules that bind to tumor surfaces or specific locations within the tumors can be attracted to the PEG shell. When exposed to near-infrared light, the dots fluoresce much brighter than dye to serve as a beacon, identifying the target cells.
The researchers said the technology enables visualization during surgical treatment, showing invasive or metastatic spread to lymph nodes and distant organs, and can show the extent of treatment response.
The first generation of Cornell Dots was developed in 2005 by Hooisweng Ow, a co-author of the paper and once a graduate student working with Ulrich Wiesner, a Cornell professor of materials science and engineering. Together, Wiesner, Ow and Kenneth Wang co-founded HST to commercialize the dots.
The collaboration is now in the process of forming a new commercial entity in New York City that will help transition the research into commercial products that will benefit cancer patient care.
“This is the first FDA IND-approved inorganic particle platform of its class and properties that can be used for multiple clinical indications, two of which are explored: cancer targeting for diagnostics and future therapeutic diagnostics, as well as cancer disease staging and tumor burden assessment via lymph node mapping,” Bradbury said.
The dots were optimized for efficient renal clearance, allowing the body to pass them through the kidneys. In addition, the researchers were able to perform real-time imaging of lymphatic drainage patterns and particle clearance rates as well as to sensitively detect nodal metastases.
Nodal mapping is now being pursued under a new award of a BioAccelerate NYC Prize from the Partnership for New York City and the New York City Economic Development Corp., which is expected to lead to another clinical trial in humans.
For more information, visit: www.fda.gov
- The emission of light or other electromagnetic radiation of longer wavelengths by a substance as a result of the absorption of some other radiation of shorter wavelengths, provided the emission continues only as long as the stimulus producing it is maintained. In other words, fluorescence is the luminescence that persists for less than about 10-8 s after excitation.
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