Taiwan will join a global clinical trial of a biopharmaceutical drug developed to treat oral cancer, one of the participating hospitals said on Wednesday.
Eight countries, including Canada and the US, will be taking part in simultaneous phase III clinical trials beginning this month, said Hao Sheng-po (侯勝博), chief of otolaryngology at Shin Kong Wu Ho-Su Memorial Hospital.
Eight-hundred patients worldwide, including 88 in Taiwan, will be participating in the trials.
Biopharamaceuticals are drugs manufactured through the use of live organisms or their active components. Examples of these drugs include insulin and vaccines.
The importance of the new clinical trials is that the drug being tested would change the role of immunotherapy from an aid and last resort in cancer therapy to a first-stage treatment, Hao said.
In the trials, immunotherapy in the form of biopharmaceutical injections will be administered to 88 cancer patients with oral tumors, Hao said.
The aim is to strengthen the immune system against cancer before turning to traditional forms of therapy, such as surgery, chemotherapy, radiotherapy and targeted therapy, he said.
The survival rates of the patients in the trials will be tracked, he said. Only patients with late-third or fourth-stage oral cancer or those who have not received chemotherapy would be allowed to participate in the clinical trials, he said.
This is because it has been found in previous research that immunotherapy tends to fail in patients who have already received traditional cancer treatments, he said.
In such cases, immunotherapy drugs are less effective because the patients’ immune systems have been battered by surgery, chemotherapy and radiotherapy, he said.
In the phase II clinical trials of the biopharmaceuticals, it was found that on average the treatment helped reduce the size of tumors in oral cancer patients by 50 percent. In 12 percent of the cases, the tumors disappeared after one month of treatment. The overall survival rate among the patients in the trial increased by 33 percent over a period of three-and-a-half years compared with the control group.
No poisoning or autoimmune disorders were observed in the first two phases of the clinical trials and other studies have indicated the biopharmaceutical drug was also found to be capable of suppressing cervical cancer.