Could This Be a Fundamental Cure for Parkinson's?... Japanese Pharma Applies for New Drug Using Stem Cells

Conditional Approval Possible by Japanese Authorities
"Demonstrating Efficacy and Safety Remains a Challenge"

Japanese pharmaceutical company Sumitomo Pharma has applied to the Ministry of Health, Labour and Welfare for the manufacturing and sale of a Parkinson’s disease drug utilizing induced pluripotent stem cells (iPS cells), the Nihon Keizai Shimbun (Nikkei) reported on August 6.

Parkinson’s disease is a condition in which the number of dopamine-producing nerve cells in the brain decreases, leading to a gradual decline in motor function. Currently, there is no known fundamental cure. According to Nikkei, Sumitomo Pharma plans to create a foundation of dopamine-producing cells from the iPS cells of healthy individuals and transplant them into the brains of patients with Parkinson’s disease.

Previously, Kyoto University conducted a trial of this treatment method on six patients with Parkinson’s disease, confirming that there were no serious side effects and that four patients experienced improvements in motor function.

However, Nikkei pointed out that the previous clinical trial involved a small number of subjects, making it difficult to sufficiently verify both the efficacy and side effects. The newspaper also noted that further investigation is needed regarding the duration of the drug’s effectiveness. Nikkei explained that the approval by Japanese authorities is likely to be conditional, and that in order to obtain full approval, a large number of treatment cases must be accumulated to demonstrate efficacy and safety.

Nikkei also stated, "iPS cells are created by introducing specific genes into skin or blood cells," and projected that Sumitomo Pharma’s latest move could contribute to the practical application and industrialization of iPS cell technology, which originated in Japan.