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Positive Two-Year Safety Data From Diabetes Trial Presented.

SAN DIEGO, Calif., June 23, 2018 -- Privately-held ViaCyte, Inc., announced positive two-year data from cohort 1 of the ongoing safety, tolerability, and efficacy of VC-01 (PEC-Encap) product candidate in type one diabetes (STEP ONE) clinical trial.

The PEC-Encap combination product candidate consists of stem cell-derived pancreatic progenitor cells (PEC-01) encapsulated in a delivery device called the Encaptra Cell Delivery System.

According to the company, the results indicate that the PEC-Encap product candidate, delivered at a sub-therapeutic dose, has to date been safe and well tolerated.

The Encaptra Cell Delivery System appears to protect the implanted cells from allo- and auto-immune rejection and the patients from sensitization.

Although consistent and robust engraftment was limited in this study, results showed that when engraftment did occur, viable mature insulin-expressing endocrine islet cells were formed.

In some cases, insulin-expressing cells persisted for up to two years after implantation, the longest time point investigated in the study.

Details from the STEP ONE trial were discussed at the American Diabetes Association's (ADA) scientific meeting in Orland, Fla.

Chief medical officer Howard Foyt said the preliminary results from the STEP ONE clinical trial suggest that the company is on the right track.

The results indicate that when successful engraftment occurs, the implanted cells survive, proliferate, and mature to cells capable of producing insulin and other regulatory hormones.

The study also showed that the Encaptra Cell Delivery System protects the cells from rejection by the patient's immune system.

STEP ONE is an open-label Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of the PEC-Encap product candidate.

The work was supported in part by grants from the California Institute of Regenerative Medicine.


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Title Annotation:Clinical Trials
Publication:Stem Cell Lab World
Date:Jun 25, 2018
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