Latest news with #SumitomoPharma
Yomiuri Shimbun
a day ago
- Health
- Yomiuri Shimbun
Japan Drugmaker Applies for Approval of Stem Cell-Derived Parkinson's Treatment; Aims to Obtain Approval Within FY25
Sumitomo Pharma Co., a major drugmaker, announced on Tuesday that it has applied to the Health, Labor and Welfare Ministry for approval to produce and sell a regenerative medical product for the treatment of Parkinson's disease. The drug contains dopamine-producing nerve cells derived from induced pluripotent stem (iPS) cells and is transplanted directly into patients' brains. It is the second application to the ministry for the approval of a regenerative medicine derived from iPS cells. Parkinson's is caused by a reduction in the nerve cells which produce dopamine, a neurotransmitter produced in the brain involved in body movement. Patients with the disease develop such symptoms as tremors in the hands or legs and have difficulty walking. In Japan, there are an estimated 250,000 people with Parkinson' treatment method was jointly developed by Sumitomo Pharma and a team of researchers from Kyoto University. These researchers conducted clinical tests from 2018 to 2021. In the tests, 5 million to 10 million nerve cells were derived from iPS cells taken from healthy people and transplanted into the patients' brains. The researchers published the results in the science journal Nature in April this year, stating that four of the six patients experienced an improvement in their symptoms. Sumitomo Pharma, which is in charge of producing the nerve cells, applied for the ministry's approval based on the test results. The regenerative medicine is covered by the government's special screening designation system, in which priority is given to applications for revolutionary medical treatments originating in Japan. According to the ministry, the length of time necessary for the screening, which is usually about a year, will likely be shortened. Sumitomo Pharma President Toru Kimura said, 'We will make utmost efforts to obtain approval by the end of this fiscal year. We want to respond at maximum speed [for the ministry's screening].' The previous application for production and sales of a regenerative medicine derived from iPS cells was submitted by Cuorips Inc., an Osaka-based startup, in April. The startup makes sheets of heart muscle cells for patients with serious heart diseases.
Nikkei Asia
4 days ago
- Health
- Nikkei Asia
Sumitomo Pharma files for approval of stem cell Parkinson's treatment
Induced pluripotent stem cell technology was developed in Japan in 2007, but progress on developing treatments for diseases has been slow. (Photo obtained by Nikkei) NANAKO TAKEUCHI, YUKI MISUMI and AKANE ASAMI OSAKA/TOKYO -- Japanese drugmaker Sumitomo Pharma has applied for approval in Japan of a stem cell-based Parkinson's disease treatment, it announced on Tuesday, looking to ease the motor symptoms of sufferers and help push the country's stem cell treatment implementation forward.
Japan Times
4 days ago
- Health
- Japan Times
Drugmaker in Japan seeks approval for stem cell treatment for Parkinson's
Sumitomo Pharma said Tuesday it is seeking approval for a Parkinson's disease treatment that transplants stem cells into a patient's brain, following a successful clinical trial. The drugmaker applied to Japanese regulators for manufacturing and marketing authorization aimed at treating patients with advanced Parkinson's disease, it said in a statement. A trial led by Kyoto University researchers indicated that the company's treatment using induced Pluripotent Stem (iPS) cells — which have the potential to develop into any cell in the body — was safe and successful in improving symptoms. The study involved seven Parkinson's patients between 50 and 69 years old, with each receiving a total of either 5 million or 10 million cells implanted on both sides of the brain. The iPS cells from healthy donors were developed into the precursors of dopamine-producing brain cells, which are no longer present in people with Parkinson's disease. The patients were monitored for two years, and no major adverse effects were found, the study said. Four patients showed improvements in symptoms, it said. The trial results were published in Nature in April. Sumitomo Pharma is also carrying out a clinical trial in the United States. Parkinson's disease is a chronic, degenerative neurological disorder that affects the body's motor system, often causing shaking and other difficulties in movement. Worldwide, about 10 million people have the illness, according to the Parkinson's Disease Foundation. Currently available therapies "improve symptoms without slowing or halting the disease progression," the foundation said. iPS cells are created by stimulating mature, already specialized, cells back into a juvenile state — basically cloning without the need for an embryo. The cells can be transformed into a range of different types of cells, and their use is a key sector of medical research.
The Hindu
4 days ago
- Health
- The Hindu
Japan firm seeks approval for stem cell treatment for Parkinson's
Japanese drugmaker Sumitomo Pharma said Tuesday it is seeking approval for a Parkinson's disease treatment that transplants stem cells into a patient's brain, following a successful clinical trial. The company applied to Japanese regulators for manufacturing and marketing authorization aimed at the treatment of patients with avanced Parkinson's disease, it said in a statement. A trial led by Kyoto University researchers indicated that the company's treatment using induced Pluripotent Stem (iPS) cells -- which have the potential to develop into any cell in the body -- was safe and successful in improving symptoms. The study involved seven Parkinson's patients aged between 50 and 69, with each receiving a total of either five million or 10 million cells implanted on both sides of the brain. The iPS cells from healthy donors were developed into the precursors of dopamine-producing brain cells, which are no longer present in people with Parkinson's disease. The patients were monitored for two years and no major adverse effects were found, the study said. Four patients showed improvements in symptoms, it said. The trial results were published inNature in April. Sumitomo Pharma is also carrying out a clinical trial in the United States. Parkinson's disease is a chronic, degenerative neurological disorder that affects the body's motor system, often causing shaking and other difficulties in movement. Worldwide, about 10 million people have the illness, according to the Parkinson's Disease Foundation. Currently available therapies "improve symptoms without slowing or halting the disease progression," the foundation says. iPS cells are created by stimulating mature, already specialised, cells back into a juvenile state -- basically cloning without the need for an embryo. The cells can be transformed into a range of different types of cells, and their use is a key sector of medical research.
Al Etihad
4 days ago
- Health
- Al Etihad
Japan firm seeks approval for stem cell treatment for Parkinson's
TOKYO (AFP) Japanese drugmaker Sumitomo Pharma said Tuesday it is seeking approval for a Parkinson's disease treatment that transplants stem cells into a patient's brain, following a successful clinical trial. The company applied to Japanese regulators for manufacturing and marketing authorisation aimed at the treatment of patients with avanced Parkinson's disease, it said in a statement. A trial led by Kyoto University researchers indicated that the company's treatment using induced Pluripotent Stem (iPS) cells -- which have the potential to develop into any cell in the body -- was safe and successful in improving symptoms. The study involved seven Parkinson's patients aged between 50 and 69, with each receiving a total of either five million or 10 million cells implanted on both sides of the brain. The iPS cells from healthy donors were developed into the precursors of dopamine-producing brain cells, which are no longer present in people with Parkinson's disease. The patients were monitored for two years and no major adverse effects were found, the study said. Four patients showed improvements in symptoms, it said. The trial results were published in Nature in April. Sumitomo Pharma is also carrying out a clinical trial in the United States. Parkinson's disease is a chronic, degenerative neurological disorder that affects the body's motor system, often causing shaking and other difficulties in movement. Worldwide, about 10 million people have the illness, according to the Parkinson's Disease Foundation. Currently available therapies "improve symptoms without slowing or halting the disease progression," the foundation says. iPS cells are created by stimulating mature, already specialised, cells back into a juvenile state -- basically cloning without the need for an embryo. The cells can be transformed into a range of different types of cells, and their use is a key sector of medical research.
