Hello everyone.As I promised, I have spoken with one of those responsible for Viacyte (the same man with whom I have always spoken, he already knows me. He is a great guy, he has even congratulated me Christmas in Spanish).I want to tell you that all the information I put is first hand, that is, direct of them.
As the conversation is long, I will simply put the conclusions:
- The degree of "enragrad" they have observed during the efficacy study has been less than expected.This means that:
1) The degree of revascularization at 8 - 10 weeks (which is the time they expect to give transition) is lower than expected after preclinical trials.I want to clarify that a few months ago I understood that it took 8 months, but they expect the final product to take about 10 weeks, during which it will have to be administered prudence.
2) The degree of differentiation.They have clarified that the cells are still inserted without differentiating in beta cells, that is, as precursors.Once inserted in the patient, they differ.Many of them have turned out not to survive.This differentiation also lasts about 8 - 10 weeks.
So that there is no confusion, this no invalidates the project, whose clinical trials continue as planned because there are still no conclusions.It is too soon because it is not yet known if the cell dose is enough.I have clarified things with respect to clinical trials.I'm going to explain how they do.
For the vc-01 encapslado (the one that interests us), they make two cohorts (two follow-up groups, let's go), one with a subterapeutic dose expressly thought to know that the product is not toxic.I tell you that this should be done in all clinical trials, I assure you.For that reason, they have not yet seen any level of insulin Independence, as they have communicated to me.Cohort 2 is to do the effectiveness of effectiveness, and it was launched from the end of this summer, both for the vc-01 encapsulated and the VC-02 not encapused, with which whatI have begun that we are patients since it is very soon to give results.
If your question is (which was what I did): Does anyone involved in that study could stop putting the insulin?The answer is that it is not yet, but it is normal because the only complete cohort is subterapeutics and for the second it is still very soon to see results, because although it is not published, it began at the end of summer and at the moment those have been found2 inconveniences with what they have not yet made patients have complete independence to insulin.Conclusion: Please, be patients because efficiency tests end just to start.
Finally, so that there are no fears, the collaboration with WS GORE is precisely to improve the survival of the pancreatic precursors that are inserted into the capsule.So if there was someone who was afraid that the VC-02 (the non-protected) was the new great project leaving aside the encapsulated, can remain calm because precisely that association is to develop a new capsule of a fluoropolymer that It has already given clearly excellent results in Animal Model. So quite the opposite of your concern.Very soon the clinical trials will begin with this new polymer, but will continue with the already encapsulated for the moment.
For my part nothing more.If you want my personal conclusion: you have to be optimistic but patients.Clinical trials can last many years.But I think they want to get this, if you look, this company has few projects and the cake is juicy.In addition, for researchers I have no doubt that it is the opportunity of their lives, they will never have any other the same.If they did not wantTo take it out, they would not have signed the millionaire contract with those of WS Gore (which by the way, are based in Barcelona) or their company would depend on such very few projects or start repeating clinical trials with the new polymer.They trust their cells, cost them too much effort to determine the factors of differentiation of beta cells.In addition, the patent ends in 20 years, it has to take advantage of it.
Well, if someone wants, I have some of these conversations in writing and more detailed information about everything that Viacyte told me.Let me send me a private and I pass my number.
Courage, we will see the functional cure.I have no doubt.