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Nanomedicine Introduces New Treatment Options

Results from a recent clinical trial suggest a drug made using nanotechnology—the application of microscopic particles to help deliver therapeutics-showed a great deal of promise in treating advanced cancer.

In a Phase I clinical trial led by Steven Libutti, MD, Director of the Montefiore Einstein Center for Cancer Care, physicians found that CYT-6091, which pairs nanoparticles with tumor necrosis factor alpha (TNF), a molecule that can block tumor cell growth, may be safely given in a more broad-based way throughout the body. This finding could open up treatment options for patients with metastatic cancer who require a less localized treatment approach to their illness because the cancer has spread away from the original tumor site. Phase I clinical trials are designed to evaluate a drug's safety.

Previously, physicians were unable to deliver the high amounts of TNF needed to induce tumor cell death because of the toxicity to patients. Now, CYT-6091, which is administered intravenously, allows for the delivery of high amounts of TNF to the patient without causing harm while also keeping TNF near the tumor site. Malignant tumors thrive on a steady blood supply, yet tumor blood vessels tend to leak more than healthy blood vessels, which makes delivering therapeutics to cut off a tumor's blood supply a challenge. CYT-6091 appeared to stick to tumor blood vessels, allowing for TNF to attack tumor cells.

Dr. Libutti and colleagues recently published their findings in the journal, Clinical Cancer Research.

"Nanomedicine provides us with a kind of trafficking phenomenon," explains Dr. Libutti. "What it helps us do is make a very toxic anti-tumor compound safe for patients."

Not all nanomedicines are the same and the platform or vehicle in which they are delivered can vary. CYT-6091 was created using previously tested compounds known to be safe in patients-thiolyated polyethylene glycol and bound to the surface of colloidal gold particles. "We didn't see any unexpected toxicities in CYT-6091," said Dr. Libutti. "One question that remains is how long nanoparticles remain in the body." Other platforms used to deliver nanoparticles, he noted, such as carbon nanotubes, which are very strong tubular structures, have not been as thoroughly tested and may pose some safety risks.

Based on the promising results of the Phase I trial, Dr. Libutti and his team will now move forward with a Phase II clinical trial, which will be designed to test how well CYT-6091 benefits cancer patients. Dr. Libutti and colleagues will study patients with different types of cancers including breast, melanoma, colorectal and pancreatic.

"This is a robust example of translational research," said Dr. Libutti. "We took an anti-cancer concept that began in the lab, tested it in a Phase I clinical trial, and now the concept is working its way to the Phase II trial," said Dr. Libutti.