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Yale researchers have created a nonsurgical injection that can treat skin cancer.

The new treatment, which was published in a paper in the journal Proceedings of the National Academy of Sciences of the United States of America on Feb. 16, involves injecting nanoparticles into skin cancer tumors. The injection was created by a collaboration between Yale’s Saltzman and Girardi labs and offers an alternative treatment to surgery. Although the treatment has not yet entered clinical trials, it is a less invasive and more effective way to combat skin cancer and could impact millions if eventually adopted, according to researchers at the labs.

“The inspiration was to try and meet the need for a local nonsurgical efficient treatment for skin cancer for all the patients who are suffering from squamous cell carcinomas,” Jamie Hu, a first-year resident at Yale and the first author on the study, said.

According to Hu, the mainstay treatment for skin cancer is currently surgical resection, or the physical removal of a tumor. Surgery, however, has lots of limitations. Some patients have tumors that are unresectable, while others experience complications or infection during or after surgery. On top of that, surgery is expensive and therefore not a reasonable option for all patients.

By creating a nonsurgical treatment option, Hu explained, patients with skin cancer could have a much easier recovery and an improved quality of life. Since one in five people develop skin cancer throughout their lives, a change in treatment would impact the care of millions.

According to Michael Girardi, one of the senior authors of the paper, a nonsurgical treatment may also be more efficient and allow multiple tumors to be treated at the same time.

“The potential is there to be able to treat skin cancer with just a needle and syringe, with a caregiver injecting one lesion or multiple lesions at the same visit, in the same amount of time it might take to numb up a lesion and treat it with standard surgery,” Girardi said.

The researchers tested the injection in mice with skin cancer tumors, the study explains.

According to the study, the treatment involves injecting bioadhesive nanoparticles that carry chemotherapy agents into skin cancer tumors. These nanoparticles then bind to the tumors and release drugs to kill the tumor over time, the study explains.

“The nanoparticle delivery system has two major components,” Girardi said. “It has a core with the anti-tumor agent within it, and it can slowly release that agent. It also has a surface coating that allows it to bind covalently to the protein matrix of the tumor as well as to the tumor cell surfaces.”

Girardi said the nanoparticles bind to surface proteins exclusively on the tumor cells. When the particles bind to these proteins, the tumor cells begin to readily internalize the particles. The drug within the particles can then destroy the tumor without hurting surrounding non-tumor tissue.

According to Hee Won Suh, a postdoctoral researcher in the Saltzman Lab, the particles are extremely effective at delivering anti-cancer agents because of their adhesive properties. Since the nanoparticles can stick to the tumors, the drugs stay in the tumor for a long time, allowing them to effectively kill it. The nanoparticles also allow for more localized treatment, Suh explained.

“We can inject the drug inside the nanoparticles directly into the tumor so you don’t have as much of a collateral damage while the drug is really working on the tumor,” Suh said.

In the study, the researchers discovered that drug delivery by nanoparticles was significantly more effective than injecting the drugs into the tumors alone.

Hu said the ultimate goal is to eventually transition the new treatment to clinical use, though she believes it could be a while before this happens.

“Bench to bedside always takes a little bit longer than we would think,” Hu said. “It’ll definitely be on the order of years before we would be doing human trials or anything like that.”

According to Girardi, a lot of funding is required to bring the injection from preclinical modeling to clinical trials. The team has applied for funding from the National Institutes of Health and has been contacted by several companies interested in working to develop the treatment.

Girardi explained that one of the next steps is a Phase 1 clinical trial. Before this can be done, however, the team needs to get approval from the Food and Drug Administration and generate a clinically acceptable form of the particles that has to be created under very sterile conditions.

“I think it will be a continual collaboration with the industry side and the academia side,” Suh said. “Some of the challenges include scaling up the production of this technology, testing it in more animals and ultimately going to clinical trials.”

According to the Skin Cancer Foundation, more people in the United States are diagnosed with skin cancer each year than all other cancers combined.

Kaitlin Flores |  kaitlin.flores@yale.edu

KAITLIN FLORES