Clinical Trial at OU Health Stephenson Cancer Center Tests Drug Derived from Deer Antlers

OKLAHOMA CITY — OU Health Stephenson Cancer Center at the University of Oklahoma Health Sciences Center was the highest-enrolling site for a clinical trial that showed promising results for a new drug to treat mouth sores caused by radiation and chemotherapy in patients with head and neck cancer. The drug, called EC-18, is unique in that it is derived from a naturally occurring compound found in deer antlers.

Radiation oncologist Christina Henson, M.D., led Stephenson Cancer Center’s participation in the trial and presented its results earlier this year to the American Society of Clinical Oncology (ASCO) and at the annual meeting of the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology. Results of the Phase 2 clinical trial were published in the ASCO conference proceedings in Journal of Clinical Oncology.

The drug’s potential is welcome news to radiation oncologists, who often see their patients suffer from inflamed and swollen mouths but have no approved treatments other than pain control.

“Most patients who are undergoing radiation, especially if they’re also receiving chemotherapy, will develop mouth sores, and there isn’t a good remedy other than managing the pain with narcotics and using special mouthwashes that are very expensive. Most patients lose a lot of weight during treatment because they have so much pain when they swallow that they don’t eat well,” said Henson, who is also an assistant professor of radiation oncology in the OU College of Medicine and director of the radiation oncology residency program.

The drug works by decreasing the amount of inflammation caused by radiation therapy. Radiation, while effective at damaging the DNA of cancer cells so they don’t replicate, also harms normal cells, which leads to inflammation and mouth sores. In the study, patients who received EC-18 saw a 35% decrease in the presence of mouth sores (called oral mucositis). In addition, study participants who received EC-18 experienced zero days of severe mouth sores, compared to 13.5 days of severe cases in patients who received placebos.

No serious side effects were reported with the drug, nor did it negatively affect patients’ white blood cell counts. Researchers also found that the drug was safe from the standpoint of cancer control because it did not protect cancer cells from the radiation.

“The drug is definitely promising,” Henson said. “Patients with these cancers are miserable. Radiation to the head and neck is considered more difficult than radiation to other parts of the body because everything is so sensitive. Most people don’t want to take narcotics for the pain, but over-the-counter pain relievers don’t cut it. It would be really nice to have an alternative.”

The drug came in a small capsule, so it was easier for patients to swallow. Henson said patients were also reassured to be taking an investigational drug that is derived from a natural substance; specifically, the antlers of Sika deer.

The clinical trial was funded by the pharmaceutical company Enzychem Lifesciences. It was double-blinded, meaning neither the study participants nor Henson knew whether they were receiving the drug or a placebo. The company has applied for Breakthrough Therapy Designation from the Food and Drug Administration, a process that expedites the development and review of a drug when evidence shows it is a substantial improvement over any existing therapies. Stephenson Cancer Center plans to participate in any further clinical trials testing the drug.