SAN DIEGO, February 3, 2021 / PRNewswire / – ViaCyte, Inc., a clinical-stage regenerative medicine company, announced today that the first patients with type 1 diabetes (T1D) have been implanted in a Phase 2 encapsulated cell release clinical trial. The encapsulation system was developed in partnership with WL Gore & Associates, Inc. (“Gore”), a global materials science company, to improve transplantation, cell survival, and overall function by reducing the foreign body host response and protecting against immune rejection provided . The study is actively recruiting and implanting patients. First safety and efficacy data are expected in the second half of 2021.
“”ViaCyte’s Phase 2 clinical program will advance a leading candidate for encapsulated cell therapy to replace the insulin-producing cells lost in type 1 diabetes. ViaCyte has shown that when transplanted, our cells produce both insulin and glucagon in T1D patients – a first in the field of cell therapy for diabetes, “he said Howard Foyt, MD, Ph.D., ViaCyte’s chief medical officer. “We look forward to confirming our preclinical and early clinical data showing that the new encapsulation can reduce foreign body response and improve cell transplantation, survival and function, and potentially lead to therapeutic results.”
“We are pleased that the new encapsulation system, developed using proprietary Gore material technology, is advancing in clinical trials,” he said Emily C. Oliver, Product Specialist, Gore PharmBIO Cell Encapsulation Products. “Working closely with ViaCyte, Gore has developed a membrane that appears to enable successful transplantation and beta-cell proliferation while minimizing the host’s foreign body response and eliminating the need for long-term immunosuppression.”
The Phase 2 clinical trial will evaluate the safety, transplantation, and efficacy of ViaCyte’s candidate for encapsulated cell therapy (VC01-103) in T1D patients (ClinicalTrials.gov Identifier: NCT04678557). ViaCyte plans to enroll an initial cohort of 10 patients in this open-label study, with the potential to expand enrollment to up to 70 patients. The study is actively recruiting T1D patients with safety and efficacy data expected in the second half of 2021.
ViaCyte’s stem cell platform is used to differentiate pluripotent stem cells into pancreatic cells that are placed in an encapsulation system that is implanted subcutaneously. ViaCyte has shown that after implantation and successful transplant, cells mature into beta cells that secrete insulin, alpha cells that secrete glucagon, and other cells in the human pancreas that naturally control blood sugar (sugar) levels . The purpose of the encapsulation system is to protect the cells from the patient’s immune system, thereby eliminating the need for immune suppression drugs commonly used in other transplants. ViaCyte is the only company that has shown in clinical studies that implanted islet cells, other than stem cells, can produce insulin in T1D patients.
ViaCyte and Gore have shown that the encapsulation system, which incorporates Gore’s advanced proprietary material technologies, reduces foreign body reaction and improves transplantation, cell survival and function in both clinical trials and preclinical models.
WL Gore & Associates is a global materials science company dedicated to transforming industry and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments – from space to the highest peaks in the world to the inner workings of the human body. With more than 10,500 employees and a strong, team-oriented culture, Gore has annual sales of $ 3.7 billion. www.gore.com
ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies from pluripotent stem cells and medical device systems for encapsulating and implanting cells. ViaCyte has the ability to use any technology individually or together to address critical human diseases and disorders that can potentially be treated by replacing lost or defective cells or proteins. The company’s first product candidates are being developed as potential long-term treatments for type 1 diabetes patients to achieve glucose control goals and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company’s efforts, ViaCyte has partnered with leading companies such as CRISPR Therapeutics and WL Gore & Associates. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego, California. For more information, please visit www.viacyte.com and connect with ViaCyte on Twitter, Facebook and LinkedIn.
SOURCE ViaCyte, Inc.