The California stem cell agency next week is slated to award an additional $4 million to ViaCyte, Inc., a San Diego firm that is working with the agency to develop a "virtual" cure for diabetes.
ViaCyte has already received $56 million over the years from the California Institute for Regenerative Medicine(CIRM), as the agency is formally known. The latest award will be used to help prepare for a clinical trial for a new treatment for the highest risk diabetes patients.
In response to a query this morning from the California Stem Cell Report, Paul Laikind, president and CEO of ViaCyte, said that the new product, PEC-Direct, will deliver the same biologic component as used in the firm's current product, which is now in a clinical trial.
Laikind said PEC-Direct will allow direct vascularization, which "is expected to allow for a very robust engraftment and cellular performance."
Because the new device will require chronic immune suppression, Laikind said,
"It is being developed to treat patients with type 1 diabetes that are at high risk for acute complications such as severe hypoglycemic events associated with hypoglycemia unawareness syndrome."(The full text of Laikind's remarks and research update can be found here.)
The agency's summary of the closed-door review of the Viacyte proposal said,
"There are over 100,000 people in the U.S. with type 1 diabetes so severe that they are at constant risk of hospitalization and/or death. Within months after administration, this product could naturally restore those patients’ blood sugar to normal healthy levels and save their lives."
In addition to the $4 million, ViaCyte is putting up $994,343 of its own cash.
CIRM's blue-ribbon panel of scientific reviewers has already approved the award, which is part of a $30 million package of applications coming up next Thursday. The governing board of the agency will ratify the approvals at its meeting next Thursday during a one-hour telephonic meeting.
The largest award, $10 million, will go to Humacyte, Inc., of North Carolina, to produce an artificial vein for use in hemodialysis as reported yesterday on the California Stem Cell Report. More details of all the applications and review summaries can be found on the meeting agenda.
The session will be audiocast and carried on the Internet on a listen-only basis. Interested parties can participate in the meeting from telephonic locations throughout the state.
The main site for the meeting will be at the Sanford consortium in San Diego. Other locations include the agency's headquarters in Oakland and sites in Davis, South San Francisco(2), Napa, Los Gatos, Sacramento, Irvine, San Francisco and Los Angeles. For specific addresses and instructions for online access, see the agenda.
CIRM has a very ambitious strategic plan of 50 clinical trials to meet, so give away public money crazy either to any clinical trials that have nothing to do with stem cell treatment, like Humacyte, or to company like Asterias/Geron, Stem Cell Inc, Viacyte that cannot run an efficacy stem cell treatment trial to pass FDA. Of course, they could not get those CIRM awards if they do not have any insiders in CIRM to form alliance to help them. Whether clinical trials like Humacyte succeed or not would not really matter to any new initiative of CIRM strategic plan, only give CIRM insiders excuses to embezzle public money and make CIRM looks as corrupted as ever been. Dr. Laikind should mention his device does not make any beta cells nor better than direct injection of insulin, Viacyte would not get CIRM $ 60 million awards if they do not have Sanford Burnham Presby on CIRM board, nor would Humacyte.
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