ProtoKinetix has announced the start of a phase 1 first-in-human clinical trial of AAGP PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type 1 diabetes. The first patient has been treated under this protocol. The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet and Living Donor Liver Transplant Programmes, Canada Research Chair in Transplant Surgery and Regenerative Medicine, Professor of Surgery, Medicine and Surgical Oncology, University of Alberta.
PKX-001 is the designation given to the drug product molecule of the AAGP family. Islet cell transplants are well recognized as a viable and effective treatment for Type 1 diabetes. The PKX-001 Study will treat islet cells prior to transplantation into human test subjects. The clinical trials will be assessing any side effects or physiological damage to the test subjects. The study will also be looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trial follows extensive preclinical evaluation in animal models.
The phase 1 first-in-human study will evaluate the safety and tolerability of AAGP PKX-001 treated islets while the phase 2 component will be evaluating the efficacy of adding AAGP PKX-001 treated islets to the already established Edmonton Protocol.
“If the findings translate to the clinic in a manner that reflects the preclinical studies, AAGP has the potential to substantially improve outcomes in patients receiving islet transplants today, and future stem cell therapies.” said Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet and Living Donor Liver Transplant Programmes, Canada Research Chair in Transplant Surgery and Regenerative Medicine, Professor of Surgery, Medicine and Surgical Oncology, University of Alberta.