Glowing Cornell Dots Developed as Cancer Diagnostic Tool for Human Trials

The US Food and Drug Administration (FDA) have approved the first clinical trial in humans of a new technology: Cornell Dots, which are brightly glowing nanoparticles that can light up cancer cells in positron emission tomography (PET) optical imaging.

An article describing this new medical technology was published on June 13, 2011, in the Journal of Clinical Investigation (July 2011 issue). The project is a collaboration between Memorial Sloan-Kettering Cancer Center (MSKCC; New York, NY, USA), Weill Cornell Medical College (New York, NY, USA), and Hybrid Silica Technologies (Cambridge, MA, USA), a Cornell business start-up.

For the first time, scientists report a uniquely sophisticated and comprehensive characterization of Cornell Dots--an ultra-small, cancer-targeted, multimodal silica nanoparticle--which has recently been approved as an investigational new drug (IND) by the FDA for a first-in-human clinical trial, according to Michelle S. Bradbury, MD, of the Memorial Sloan-Kettering Cancer Center and an assistant professor of radiology at Weill Cornell Medical College.

Cornell Dots are silica spheres less than eight nanometers in diameter that enclose several dye molecules. The 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 the body will not recognize them as foreign substances.

To make the dots adhere to tumor cells, organic molecules that bind to tumor surfaces or even specific locations within tumors can be attached to the PEG shell. When exposed to near infrared light, the dots fluoresce much brighter than dye to serve as a beacon to identify the target cells. The technology, the researchers noted, enables visualization during surgical treatment, showing invasive or metastatic spread to lymph nodes and distant organs, and can reveal the extent of treatment response.

Hooisweng Ow, a coauthor of the article and once a graduate student working with Ulrich Wiesner, a Cornell professor of materials science and engineering, developed first-generation Cornell dots in 2005. Together, Prof. Wiesner, Mr. Ow, and Dr. Kenneth Wang, have cofounded the company Hybrid Silica Technologies (HST) to commercialize the invention. The combined team of MSKCC, Cornell, and HST researchers is now in the process of forming a new commercial entity in New York City that will help convert 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," said Dr. Bradbury.

The Cornell Dots were optimized for efficient renal clearance, allowing the body to pass them through the kidneys. Moreover, the scientists were able to perform real-time imaging of lymphatic drainage patterns and particle clearance rates, as well as 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.

Related Links:
Memorial Sloan-Kettering Cancer Center
Weill Cornell Medical College
Hybrid Silica Technologies