On Wednesday, January 27th, 2016 TuDiabetes will be hosting Paul Laikind, CEO of ViaCyte Inc., in a live interview. Details here.
Latest news from ViaCyte:
On Monday, Jan 11, 2016, ViaCyte presented at the annual JP Morgan Biotech Conference, during which it provided a brief update on its VC-01 encapsulated cell therapy phase 1 clinical trial. Below, please find background and messaging to assist you with any inquires.
To date, 12 patients at two trial sites (San Diego and Alberta, Canada) have been implanted with a sub-therapeutic dose of the company’s VC-01 encapsulated cell therapy product candidate.
This first cohort is intended to evaluate the safety of the product and optimize surgical and post-surgical procedures.
Findings presented from a single trial participant at week 12 of the study showed the implanted cells were surviving and developing into insulin-producing beta cells, suggesting the potential for long term cell survival and maturation.
The device appears to be working as designed, and to date there have been:
No severe adverse events
No hypoglycemic episodes
No evidence of immune system rejection or sensitization
No off-target growth detected
DRF is encouraged by the findings ViaCyte presented at the JP Morgan Biotech Showcase, but it’s important to note that the information presented represents very early findings in a phase 1 study intended to look at safety of ViaCyte’s experimental device. It is too early to determine the overall outcomes of this study.
It is encouraging, however, that researchers are seeing biomarkers of beta cell differentiation in this sub-therapeutic dose in at least one of the volunteers. If this phase 1 study is successful in proving safety of the VC-01 product candidate, researchers will advance to testing whether this experimental therapy is successful in controlling blood sugar levels in volunteers with T1D.
ViaCyte is continuing enrollment of this first cohort of trial participants. The current focus is on improving cell survival and consistency of results. Once that is achieved, the company will report the findings to the Data Safety Monitoring Board and seek recommendations to proceed with a second cohort, which would begin to evaluate efficacy of VC-01.
ViaCyte is designing additional clinical approaches to utilize the VC-01 product candidate in different populations of individuals with diabetes.