Govt Support Bolsters Pharmicell’s Stem Cell Therapy Plans
This article was originally published in PharmAsia News
Executive Summary
Pharmicell is to kick off the development of a stem cell-based therapy for chronic kidney disease and a gene therapy for liver cancer with support from the South Korean government, which is nurturing the development of both sectors as part of a national strategic plan.
SEOUL - Pharmicell Co. Ltd.'s stem cell therapy for chronic kidney disease and stem cell-based gene therapy for liver cancer have been selected as projects that will receive R&D grants from the South Korean government.
The company will proceed with development of the gene therapy for liver cancer with a research team led by Professor Chae-Ok Yun of Hanyang University, with the project to receive support from the state-run Small and Medium Business Administration.
The purpose is to establish manufacturing technology for a mesenchymal stem cell-based gene therapy using an oncolytic adenovirus to treat liver cancer. It plans to verify the effect in animal models to establish a basis for commercialization.
Pharmicell said oncolytic adenoviruses have been under the spotlight as gene carriers to treat cancer as they can selectively kill maliignant cells, but when injected in vivo, while the adenoviruses induce strong immune response, they are less effective against metastatic cancer cells as they remain in the blood for only a short period.
By using mesenchymal stem cells as the carrier, the therapy can overcome such limitations, it said.
The mesenchymal stem cells cultured by Pharmicell move to damaged areas when injected and as they cause little immune rejection response, can be injected into the entire body. The hope is that they can play an outstanding role as a tumor-targeting vehicle for delivering oncolytic genes for incurable cancers.
Once it successfully completes testing in animal models, Pharmicell plans to proceed with toxicity and activity tests to confirm safety and efficacy, and then plans to begin clinical trials as a basis for eventual regulatory approvals.
To proceed with the program, Pharmicell and the Hanyang University research team have jointly conducted a basic study on brain cancer cells and confirmed the approach’s ability to selectively kill cancer cells.
Kidney Disease Project
Pharmicell has also launched the joint development of the stem cell therapy for chronic kidney disease with a research team at Asan Medical Center, with this project selected to receive support from the Ministry of Health and Welfare.
It again aims to verify the efficacy of the therapy and enable clinical development for commercialization. The other major aim is to establish the manufacturing process and quality control system for allogeneic marrow-derived stem cells with stronger activity, by using a hypoxic culture process and Pharmicell's proprietary stem cell technology, said Asan Medical Center's Professor Cheong-Soo Kim.
The company will use stem cells from healthy donors in the research and by using a new culture method, the aim is to mass produce safe therapies with consistent efficacy.
An official at Pharmicell noted that chronic kidney disease is essentially incurable and can't be fundamentally treated unless the patient undergoes a transplant, which would require immunosuppressant therapy.
"The industry desperately needs to develop a stem cell therapy that can be engrafted without damage in renal ischemia-reperfusion during the transplantation process. Through the latest research, we decided that the hypoxic treatment of mesenchymal stem cells is the optimal method that can maximize protection of kidney when an ischemia-reperfusion injury occurs," said the official.