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Amendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials by the University of Alberta Submitted to Health Canada
Amendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials by the University of Alberta Submitted to Health Canada.
About this update from Protokinetix, Inc.
[{"type":"text","content":"\nProtoKinetix, Incorporated (www.protokinetix.com) (the \"Company\" or \"ProtoKinetix\") (OTCQB: PKTX), a clinical-stage biomedical company, today announced an update to the Press Release of March 24, 2020. The amendments to the clinical trial protocol have been submitted by the University of Alberta to Health Canada for their review. Upon approval from Health Canada and upon final approval by the University of Alberta ethics committee, the Company will be immediately delivering over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial.\n\n\nPKX-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 PKX-001 study will treat islet cells prior to transplantation into informed patient participants. The clinical trials primary objective is the establishment of patient safety. We are now looking at optimixing 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).\n\n\nThe 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.\n\n\nDr. James Shapiro Bio \nDr. James Shapiro Video \nAbout the Edmonton Protocol \nDiabetes Research Institue Foundation Canada Video\n\n\nTo obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov – Islet Transplantation Using PKX-001.\n\n\nSee the promising research of AAGP® and results to date\n\n\nVisit our new website at ProtoKinetix.com for more information and to join our email list.\n\n\nAbout ProtoKinetix, Incorporated \n\n\nProtoKinetix is a clinical-stage molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP®) that enhance both engraftment and protection of transplanted cells, tissues and organs...