ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB: PKTX), a clinical-stage biomedical company, today announced Phase I clinical trials of AAGP® (PKX-001) treated islet cells have resumed at the University of Alberta, Edmonton. All clinical trials were paused in 2020 due to COVID-19 restrictions in the province.
The Phase 1 trials, conducted by renowned surgeon Dr. James Shapiro, focus on the impact of PKX-001 treated islet cells transplanted into patients suffering from Type-1 diabetes. Data from the initial Phase 1a illustrated the safety of using the patented PKX-001 molecule as an enhancement to transplanted islet cells in six study patients. Study protocols have been modified for Phase 1b, focusing on the efficacy of the PKX-001 treated islet cells transplanted in a process known as the Edmonton Protocol. Under the new protocols, the first patient out of a total of 10 has entered into this Phase 1b trial Type-1 diabetes patients to be treated.
PKX-001 is the designation given to the lead drug product molecule of the AAGP® family. Islet cell transplants are well recognized as a viable and effective treatment for Type-1 diabetes. The study will treat islet cells with PKX-001 prior to transplantation into informed patient participants. The clinical trials primary objective is to establish patient safety. We are now looking at optimizing these trials for efficacy by dose escalation. The study will also be making observations related to indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trial follows extensive preclinical evaluation in experimental models (to learn more, refer to this link: Diabetes).
The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet and Living Donor Liver Transplant Programs, Canada Research Chair in Transplant Surgery and Regenerative Medicine, Professor of Surgery, Medicine and Surgical Oncology, University of Alberta.
“We are delighted to have increased dose and reactivated this exciting AAGP® trial, and transplanted our next patient on April 12, 2021. We eagerly await definitive results as we move forward.” – Dr. James Shapiro
To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001.
See the promising research of AAGP® and results to date. The Islet Cell Transplantation study is encouraging and additionally supports ProtoKinetix’s efforts to develop PKX-001 for other indications, including (but not limited to) stem cell transplantation in Wet and Dry Age-related Macular Degeneration and potential use in Dry Eye Disease. ProtoKinetix aims to investigate PKX-001 for these and other indications based on robust preclinical evidence.
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