According to The Nikkei Asian Review, Australian medical venture Cynata Therapeutics will start clinical trials in Japan and the U.S. for a stem cell-based treatment for transplant patients under a licensing agreement with Fujifilm Holdings.
The licensing agreement with Fujifilm, which holds a 10%-plus stake in Cynata, will be signed within the current fiscal year, with the second phase of clinical trials starting in fiscal 2019, Ross Macdonald told reporters.
Cynata is developing a type of stem cell therapy that will treat complications from organ or bone marrow transplants in which immune cells from the donated tissue attack the patient.
Mesenchymal stem cells are shown to suppress the immune response by transplanted tissue. Cynata grows the mesenchymal cells from induced pluripotent stem cells -- which are artificially derived from adult cells. The company recently completed the first phase of clinical trials, which were primarily conducted in the U.K. and involved a handful of patients. The testing so far proved the treatment effective and safe, the company reported.
JCR Pharmaceuticals already markets the mesenchymal stem cell product Temcell domestically. Macdonald said Cynata's treatment candidate is expected to lower costs since it has a simpler production process and requires less frequent dosage.
Unlike Temcell's mesenchymal cells harvested directly from donors' bone marrow, using iPS cells can help achieve consistent quality and stable production, Macdonald said.
Japan already has in place a system that promotes regenerative medicine, Macdonald. In the U.S., the Food and Drug Administration has designated Cynata's treatment, CYP-001, as an orphan drug targeting a rare medical condition, making it eligible for government incentives.
Sales approval is targeted for fiscal 2022 at the latest.
In addition, Cynata is researching mesenchymal cell treatments for strokes and circulatory diseases. The company said it is considering partnering with Fujifilm on clinical trials targeting other maladies. The pair entered into a capital tie-up in 2016.
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