PEC-Direct (PEC-01) / Vertex - LARVOL DELTA

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness (clinicaltrials.gov) - P1/2 | N=49 | Completed | Sponsor: ViaCyte | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Oct 2023 | Trial primary completion date: Aug 2024 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: ViaCyte | N=75 ➔ 49 | Trial completion date: Feb 2024 ➔ Sep 2024 | Trial primary completion date: Nov 2023 ➔ Aug 2024

Enrollment change • Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Further Clinical Evaluation of Stem Cell-Derived Islet Replacement Therapy (VC-02) Demonstrates Production of C-Peptide with Improvements in Glycemic Control Parameters in Multiple Patients with Type 1 Diabetes and Hypoglycemia Unawareness) (ENDO 2022) - "Importantly, these data and observations have been obtained at separate clinical sites involving different surgeons, indicating that the achievement of functional engraftment of PEC‑Direct is reproducible with proper product handling, surgical training, and patient compliance with an adjunctive immunosuppression regimen. These data provide further proof‑of‑concept that continued optimization of PEC‑Direct can result in a functional cure for T1D."

Clinical • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: ViaCyte | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: ViaCyte | Trial completion date: Mar 2023 ➔ Feb 2024 | Trial primary completion date: Dec 2021 ➔ Nov 2023

Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device. (PubMed, Cell Rep Med) - "Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants."

Clinical • Journal • Diabetes • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

[VIRTUAL] Stem Cell–Derived Islet Replacement Therapy (VC-02) Demonstrates Production of C-Peptide in Patients with Type 1 Diabetes (T1D) and Hypoglycemia Unawareness (ADA 2021) - "Novel cell replacement therapies to address T1D, including VC-02 (PEC-Direct), have demonstrated the ability to control disease state and mitigate diabetes-related complications due to the absence of insulin and glycemic variability...This effect was accompanied by an increase in time-in-range from 56 to 86% and reduction in HbA1C by 0.5%. Together, these data provide clinical proof-of-concept that further optimization of this therapy can result in a functional cure for T1D."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™ (clinicaltrials.gov) - P=N/A; N=200; Enrolling by invitation; Sponsor: ViaCyte; Trial completion date: Nov 2021 ➔ Nov 2023; Trial primary completion date: Nov 2021 ➔ Nov 2023

Clinical • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus (clinicaltrials.gov) - P1/2; N=69; Active, not recruiting; Sponsor: ViaCyte; Trial completion date: Jan 2021 ➔ Jun 2021; Trial primary completion date: Jan 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

VC01-103: A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: ViaCyte

Clinical • New P1/2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Short De-Etiolation Increases the Rooting of VC801 Avocado Rootstock. (PubMed, Plants (Basel)) - "In contrast, transcripts encoding pectin methylesterase and pectolyases were enriched in the de-etiolated branches. Taken together, it seems that the short de-etiolation period led to fine tuning of the conditions favoring adventitious root formation in terms of auxin-ethylene balance and cell-wall properties."

Journal

Age and Sex Influence the Neuro-inflammatory Response to a Peripheral Acute LPS Challenge. (PubMed, Front Aging Neurosci) - "We assessed the expression of different inflammatory mediators, and the microglial response through binding of [F]-VC701 tracer to translocator protein (TSPO) receptors in the male and female brain...Moreover, our results might set the basis for further studies aimed at identifying sex-related targets involved in the modulation of the aberrant neuro-inflammatory response that characterizes aging. This knowledge could be relevant for the treatment of conditions such as delirium and dementia."

Journal

New prevention products in the pipeline (IAS-HIV 2019) - "...AMP studies assessing safety, tolerability, and efficacy of VCR01 infusion shows high retention (96%) and adherence (up to 100%) but a next-generation monoclonal antibody (VCR07) shows higher potency at lower plasma concentrations...Myron Cohen reflected on the development of long-acting Cabotegravir (LA CAB) where HPTN 083 and 084 will examine the safety and efficacy of LA CAB vs. TDF/FTC for PrEP in HIV uninfected...Prevention needs will vary based on the needs of those accessing interventions i.e. age and gender-targeted approaches but most of all investment for more prevention tools, people-oriented and collaborative approaches will enable us to stock the pipeline with options and ensure the success of the implementation. The session acknowledges planning for implementation of prevention technologies and the importance of answering key questions around STIs and efficacy."