Clinical trial at OU Health tests drug derived from deer antlers
TULSA, Okla. (KTUL) — The OU Health Stephenson Cancer Center at the University of Oklahoma Health Sciences Center was the highest-enrolling site for a clinical trial.
This showed promising results for a new drug to help treat mouth sores caused by radiation and chemotherapy in patients being treated for head and neck cancers.
The drug is called ECC-18 and is unique in the fact that it is derived from a naturally occurring compound found in deer antlers.
Radiation oncologist Christiana Henson, M.D., led Stephenson Cancer Center's participation in the trial.
She presented its results earlier this year to the American Society of Clinical Oncology as well as at the annual meeting of the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology.
The results from the Phase 2 clinical trial were published in the ASCO conference proceedings in the "Journal of Clinical Oncology."
The potential of the drug has been great news to radiation oncologists who often see their patients suffer from inflamed and swollen mouths but have yet to have any 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 at the OU College of Medicine and director of the radiation oncology residency program.
This drug works to decrease the amount of inflammation caused by radiation therapy.
Although radiation is effective, it is damaging of the DNA in cancer cells, causing them to not replicate. It also harms normal cells, leading to inflammation and mouth sores.
In the study, patients who received the EC-18 drug saw a 35% decrease in the presence of mouth sores.
Additionally, study patients experienced zero days of severe mouth sores compared to 13-and-a-half days of severe cases in patients that received placebos.
There were no serious side effects reported with the drug and it did not negatively affect patients' white blood cell counts.
Researchers found that the drug was safe from cancer control because it did not protect cancer cells from radiation therapy treatment.
“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 comes in a small capsule, making it easy for patients to swallow.
This trial was funded by the pharmaceutical company Enzychem Lifesciences and was double-blinded, meaning participants nor Henson knew whether they were receiving a placebo or drug.
The company has applied for Breakthrough Therapy Designation from the Food and Drug Administration which is a process that expedites the development and review of a drug when evidence shows it is a substantial improvement over other therapies.
The Stephenson Cancer Center says it plans to participate in any further clinical trials testing the drug.