Great News: FDA Nod For ViaCyte IND of Diabetes Stem Cell-Based Product

VIACYTE, INC. LOGOType 1 Diabetes is a huge global problem.

Where are the solutions that would compliment or replace insulin therapy for diabetics?

There haven’t been too many that have gotten very far, which makes the news of a potential stem cell-based therapy moving along in the pipeline all the more exciting.

ViaCyte (see more posts here, here, here, here on the company) just got FDA approval for its investigational new drug (IND), paving the way to start a combined Phase I/II clinical trial. ViaCyte was one of four “good citizen” stem cell biotechs that I gave a shout out to in my book on stem cells.

The drug, VC-01, is an embryonic stem cell-derived product consisting of pancreatic progenitor cells (PEC-01 cells) delivered in a capsule (Encaptra device).

In mice, the product effectively treats a model of Diabetes and stabilizes blood sugar. Not too high and not too low. I really think there’s some hope here for human patients down the road with this and other similar kinds of approaches.

What Diabetic patients would be eligible for the trial? According to MarketWatch, about 40 patients with severe disease would be enrolled:

The Phase 1/2 clinical study will evaluate the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.  In addition to evaluating the safety of the product candidate in these patients, the study is designed to demonstrate the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease.  In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites.

You stock investors out there might be getting excited about ViaCyte, but unfortunately at present time it is a privately held company. This is one that even I, usually a very cautious investor, might consider buying the stock of if it goes public.

ViaCyte’s work has been funded by both CIRM and JDRF:

“We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to initiating this study shortly” said Paul Laikind, Ph.D., President and Chief Executive Officer of ViaCyte.  “The commencement of this clinical trial marks a significant milestone for ViaCyte, as we begin studying the use of the VC-01 product candidate for the treatment of type 1 diabetes.  Instrumental in our ability to achieve this milestone are JDRF, the leading global organization focused on type 1 diabetes (T1D) research, and the California Institute for Regenerative Medicine, a leading organization focused on advancing stem cell research and regenerative medicine.  Both organizations have been strong supporters of the work we are doing at ViaCyte.”

This is a really big deal and a reason to cautiously have hope for the future of stem cell-based therapies for Type I Diabetes.

 

8 thoughts on “Great News: FDA Nod For ViaCyte IND of Diabetes Stem Cell-Based Product


  1. How would the issue of potential immune reaction be resolved during the trial since it’s a hESC-derived product?


    • The capsule in theory keeps patient’s immune cells separate from the transplanted cells inside, while letting insulin come out and glucose go into the capsule.


  2. How do I sign up for the trail? I produce no insulin what so ever. I would like more then anything to help find a cure.


  3. Diabetes or more particularly, methods for fundamentally addressing it, is at a VERY exciting time in the human story. ie, Viacyte and also the work of the likes of Orgenesis [pre clinical] and Mesoblast [now a number of years into trials re T2D]. This is good, as all the data shows, we really need much better forms of real treatment, that address underlying needs!

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