Sunday, October 22, 2017

ViaCycte Update: Clinical Trials for a Diabetes Device Plus the Rain Gear Connection

ViaCyte, Inc., is a San Diego stem cell firm working on what could be a virtual cure for diabetes -- one that the $3 billion California stem cell agency has supported handsomely for years. 

UC Davis researcher Paul Knoepfler last week carried a piece on his blog on ViaCyte's progress. The article came in the form of a Q&A with the firm's president, Paul Laikind.
Paul Laikind, CEO Viacyte

The interview covered a lot of scientific ground as well as some financial matters dealing with the firm and its clinical trials. Perhaps a good part of the bottom line was contained in this paragraph from Laikind.
"Near term, as the PEC-Direct clinical trial advances into Cohort 2, full enrollment is expected in the second half of 2018 with evaluation of efficacy about 6 months later. The primary efficacy endpoint is clinically relevant insulin production, as measured by C-peptide 6 months after implantation. While the efficacy analysis is expected to occur in 2019, patients will remain in the study for two years, thus the expected completion date for the Phase 1/2 study is December 2020."
Also of interest is the use of a product from the company that produces Gore-Tex, a fabric that took the rain gear industry by storm, so to speak, decades ago. The fabric is now used in a wide variety of medical applications. Here is what Laikind said about the Gore-Tex connection.
"The goal of the research agreement with W.L. Gore & Associates is to cooperatively establish new methods of effectively delivering cell therapies, specifically with improvements in the Encaptra Cell Delivery System used in PEC-Encap. The semipermeable membrane that is a key component of the Encaptra device is made of the same material that makes up Gore-Tex. The Gore team are the world’s leading experts for manipulating and engineering this material.
"Gore has expertise in medical device development and drug delivery technologies, as well as previous research and development experience on cell encapsulation and implant programs for diabetes. Gore’s contribution to the material and design improvements of the Encaptra Cell Delivery System is expected to support the reliable and robust long-term engraftment that is required for the PEC-Encap product to be most effective.
"Gore’s participation in ViaCyte’s financing announced in May 2017 represents another external validation of the company and its technologies. It also reflects Gore’s great interest in, and commitment to, the development of a successful implantable cell therapy for all patients with diabetes who use insulin."


  1. Anonymous11:39 AM

    Viacyte’s spokesman usually hardly mentions that their cells barely produce any insulin, efficacy is as good as none, throwing more money to them won’t make their efficacy any better. What’ve made them supported handsomely for years and have exclusive news coverage is more likely because of the firm’s president, Laikind, was from SBP, have CIRM board member, not because what they’ve done, so did a lot of CIRM awardees, such as Stem Cell, Geron/Asterias, etc. If their cells really worked, it wouldn’t take these firms tens of millions and over five or ten years still doing safety trials, and even unsure any bonus is from their cells or not. Taking advantage of their position and connection to get state and federal money has become so common, it’s really hard to draw the line between what they praise on the news and what they crack down nowadays.

    1. Anonymous- when did you arrive on the scene? Do you know anything about the history of this project? Viacyte originated as Cythera, and mergers with other companies, including Bresagen and Arcos, led to them having NIH-eligible NIH hESCs in 2001.
      Had you been paying attention to this field, you'd know that the islet cells are immature when they are transplanted...interestingly, Doug Melton has also now decided that this is a good idea. They differentiate after transplantation into all of the multiple cell types that make up islets. The problem Viacyte had was that in an effort to protect the cells from the immune system (Type I diabetes is an autoimmune disease), they prevented them from getting a good enough blood supply. The new grant fixes this by encapsulating the young islets in a permeable bag that allows them to get vascularized, which is the normal condition of pancreatic cells.
      Disclaimer: I was a founder of Arcos, and know all this history because I have been working on hESCs since the beginning.

  2. Earlier this week, ViaCyte declined an offer from the California Stem Cell Report to respond to the anonymous remarks about its work.