WRITTEN BY: Todd Boudreaux
On October 3, 2019, ViaCyte presented positive preliminary data from the PEC-Direct trial. The data shows that their PEC-01 cells are capable of producing C-peptide in patients with Type 1 diabetes. C-petide is a biomarker for insulin and is used for assessing insulin-producing cells in patients with T1D.
PEC-01 cells are derived from stem cells and designed to mature into human pancreatic islet cells, including glucose-responsive insulin-secreting beta cells, following implant.
“ViaCyte is the first and only company in human clinical trials with a stem cell-derived islet replacement therapy candidate, and we are now the first to demonstrate production of C-peptide in patients receiving implanted stem cell-derived islets. These data show that our PEC-01 cells are functioning as intended when appropriately engrafted,” said Paul Laikind, Ph.D., Chief Executive Officer and President of ViaCyte. “While there is still more work to be done, this is an important milestone. We plan to present additional data in the near future.”
The PEC-Direct trial focuses on implanting PEC-01 cells in patients with T1D who are considered high risk for complications, including coma and death, and still requires the use of immunosuppressive drugs. High risk patients may have hypoglycemia unawareness, high glycemic variability or recurrent severe hypoglycemic episodes. Many of these patients are also eligible for cadaver islet transplants, however cadaver islet cells are in short supply. PEC-01 cells, which can be produced in a lab in potentially unlimited quantities, provide a potential solution to the supply issue.
ViaCyte is currently conducting another trial using the same PEC-01 cells called PEC-Encap, which would deliver the cells from an encapsulated device and would not require the use of immunosuppressants. The positive data reported from the PEC-Direct trial is good news for PEC-Encap as well.
“Today, ViaCyte presented preliminary data from its PEC-Direct therapy clinical trial, which showed that implanted cells, when effectively engrafted, are capable of producing insulin in people with Type 1 diabetes,” said Aaron J. Kowalski, Ph.D., president and CEO of JDRF. “Advancing research in beta cell replacement is a core pillar of JDRF’s research strategy and we have been a significant supporter of ViaCyte and other promising approaches. This progress is an encouraging milestone that shows the research being conducted today is bringing us one step closer to finding cures for Type 1 diabetes.”