SAN DIEGO, July 21, 2016 /PRNewswire/ -- ViaCyte, Inc., a
privately-held regenerative medicine company, today announced that
the California Institute for Regenerative Medicine (CIRM) approved
a grant of $3.9 million to support
pre-clinical development of ViaCyte's PEC-Direct cell therapy
product candidate, which is being developed for a subset of type 1
diabetes patients. The PEC-Direct product candidate delivers
stem cell-derived PEC-01 pancreatic progenitor cells in a device
designed to allow direct vascularization of the cells, and is being
developed for type 1 diabetes patients that have severe
hypoglycemic episodes, extreme glycemic lability, and/or impaired
awareness of hypoglycemia.
"We are grateful to CIRM and the citizens of California for their continued support of our
potentially transformative stem cell-derived, cell replacement
therapies for diabetes," said Paul
Laikind, Ph.D., President and CEO of ViaCyte. "With
PEC-Direct we intend to address a critical unmet medical need for
people who are most severely impacted by type 1 diabetes.
These funds will support our pre-clinical studies as we prepare to
initiate clinical development of PEC-Direct early next year."
ViaCyte is also actively developing the PEC-EnCap (formerly
known as VC-01™) product candidate, which delivers pancreatic
progenitor cells in an immunoprotective device. PEC-EnCap is
currently being evaluated in a Phase 1/2 trial in patients with
type 1 diabetes who have minimal to no insulin-producing beta cell
function. PEC-EnCap is the first pluripotent stem
cell-derived islet replacement therapy for the treatment of type 1
diabetes in clinical-stage development.
"We have early clinical demonstration of the principle of the
PEC-EnCap approach, having shown that engraftment and
differentiation to beta cells is feasible based on analyses at
twelve weeks post-implant. Optimization efforts are
continuing to ensure robust and consistent engraftment with
PEC-EnCap before exploring higher doses to demonstrate efficacy,"
said Dr. Laikind. "ViaCyte remains committed to the
development of PEC-EnCap, which we view as a potentially
transformational therapy for the majority of people who use insulin
to manage their diabetes. While PEC-Direct development could
advance more rapidly and make a major impact for the subset of type
1 diabetes patients at highest risk, we view PEC-EnCap as holding
the promise of a functional cure for all patients with type 1
diabetes as well as an important therapy for many patients with
type 2 diabetes."
PEC-Direct delivers the same PEC-01 pancreatic progenitor cells
as PEC-EnCap but does so in a device designed to allow direct
vascularization. This direct vascularization is expected to
allow for a robust engraftment and cellular performance similar to
the anatomy of a normal islet. Given the open nature of the
device, patients implanted with PEC-Direct, as with other
transplants, would require chronic immune suppression. Thus
it is being developed to treat patients with type 1 diabetes that
are at high risk for acute complications such as severe
hypoglycemic episodes, including patients with extreme glycemic
lability and/or impaired awareness of hypoglycemia.
"This high-risk patient population is the same population that
would be eligible for cadaver islet transplants, a procedure that
can be highly effective but suffers from a severe lack of donor
material," said Dr. Laikind. "We believe PEC-Direct could
overcome the limitations of islet transplant by providing an
unlimited supply of cells, manufactured under cGMP conditions, and
a safer, more optimal route of administration."
For more information about ViaCyte's clinical trials, please
visit: https://clinicaltrials.gov/.
About ViaCyte
ViaCyte is a privately-held regenerative medicine company
developing novel cell replacement therapies as potential long-term
diabetes treatments to reduce the risk of hypoglycemia and
diabetes-related complications. ViaCyte's product candidates
are based on the derivation of pancreatic progenitor cells, which
are then implanted in durable and retrievable delivery
devices. Once implanted and matured, these cells are designed
to secrete insulin and other regulatory factors in response to
blood glucose levels. ViaCyte has two products in
development. The PEC-Direct product candidate delivers the
pancreatic progenitor cells in a non-immunoprotective device and is
being developed for type 1 diabetes patients that have severe
hypoglycemic episodes, extreme glycemic lability, and/or impaired
awareness of hypoglycemia. The PEC-EnCap (formerly VC-01™)
product candidate delivers pancreatic progenitor cells in the
Encaptra® immunoprotective device, and is currently being evaluated
in a Phase 1/2 trial in patients with type 1 diabetes who have
minimal to no insulin-producing beta cell function. ViaCyte
is headquartered in San Diego,
California with additional operations in Athens, Georgia. The Company is funded
in part by the California Institute for Regenerative Medicine
(CIRM) and JDRF.
For more information please visit www.viacyte.com. Connect
with ViaCyte here: www.twitter.com/viacyte and
www.facebook.com/viacyte.
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SOURCE ViaCyte, Inc.