With $10 million raised in financing and the ‘go-ahead’ from both the U.S. Food and Drug Administration (FDA) and Health Canada, ViaCyte is ready to begin human clinical trials of the PEC-Direct product candidate.
The PEC-Direct product candidate is designed to allow blood vessels to directly interact with the pancreatic progenitor cells contained inside the device. As such, PEC-Direct will require immunosuppression therapy, and is being developed for type 1 diabetes patients that are at a higher risk of death due to complications, such as severe hypoglycemic episodes, extreme glycemic lability and hypoglycemia unawareness.
When asked about working with the FDA for initiation of this clinical trial, president and CEO, Paul Laikind, Ph.D., told Medical Device Daily, “The FDA recognizes that we’re breaking new ground here and they are very engaged in what we’re doing.”
FierceBiotech reported the funding comes from Gore, who ViaCyte partnered with in March, JDRF and Asset Management Partners as well as one other undisclosed investor. Some of this funding will also be used to support the development of ViaCyte’s other product candidate, PEC-Encap.