Redaporfin proof-of-concept clinical trial just revealed promising results in the treatment of advanced cancer head and neck cancer.
"At this stage, the investigational new medicinal product proved to be safe, well-tolerated by the patients and effective in the treatment of advanced head and neck cancer. Photodynamic therapy with Redaporfin caused a significant reduction of the tumor tissue, in the irradiated area. In patients treated with a single dose of 0.75 mg/kg of redaporfin (effective dose), the side effects observed were not relevant and were easily controlled with simple therapeutic measures" reveals Lúcio Lara-Santos, surgical oncologist of the Portuguese Institute of Oncology-Porto (IPO-Porto) and the Principal Investigator of the clinical trial.
The results allow to predict that this will be a very useful therapy in the treatment of head and neck tumors, associated or not with other oncology drugs, whether chemotherapy or new drugs such as immunotherapy, and in the treatment of tumors that are resistant to common therapies.
"The drug passed one of its riskiest phases of development, the first-in-human clinical trial, and the tumor regression observed after treatment broaden the range of therapeutic options for patients who were already at the stage of palliative care. In addition, the results seem to indicate that this therapy can also be favorable in the treatment of other solid tumors, which represents a new hope for thousands of patients" reveals Sérgio Simões, Chairman of Luzitin, SA, a company belonging to the Bluepharma Group, and responsible for the development of the drug.
The next steps in the development of Redaporfin involve the conduct of a pivotal clinical trial in cholangiocarcinoma, a rare type of cancer, usually diagnosed at a very late stage of the disease, with a very poor prognosis and that has been on the rise in the world.
Following positive results of this new clinical trial, it is expected that in 2021 it will be possible to submit the application for marketing authorization to the European Medicines Agency (EMA) and to the Food and Drug Administration (FDA), and obtain the market approval of Redaporfin worldwide.