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ProtoKinetix Announces Start of Phase 1 & Phase 2 Clinical Trials for the use of AAGP™ PKX-001 Treated Islet Cells in the Treatment of Type 1 Diabetes
ProtoKinetix Announces Start of Phase 1 & Phase 2 Clinical Trials for the use of AAGP™ PKX-001 Treated Islet Cells in the Treatment of Type 1 Diabetes.
About this update from Protokinetix, Inc.
[{"type":"text","content":"\n \n ProtoKinetix, \n Incorporated (OTC: PKTX) (the \"Company\" or \"ProtoKinetix\") (www.protokinetix.com) \n today announced the start of a Phase 1 first-in-human clinical trial of \n AAGP™ PKX-001 treated islet cells used in conjunction with the Edmonton \n Protocol for the treatment of Type 1 diabetes. The first patient has \n been treated under this protocol. The trial is being led by Dr. James \n Shapiro, MD, PhD, FRCSC, MSM FCAHS, AHS Director of Clinical Islet and \n Living Donor Liver Transplant Programs, Canada Research Chair in \n Transplant Surgery and Regenerative Medicine, Professor of Surgery, \n Medicine and Surgical Oncology, University of Alberta.\n \n \n To obtain additional information and updates regarding the trials \n please use the following link:\n \n \n https://clinicaltrials.gov/ct2/show/NCT03073577?term=pkx-001&rank=1\n \n \n PKX-001 is the designation given to the drug product molecule of the \n AAGP™ family. Islet cell transplants are well recognized as a viable and \n effective treatment for Type 1 diabetes. The PKX-001 Study will treat \n islet cells prior to transplantation into human test subjects. The \n clinical trials will be assessing any side effects or physiological \n damage to the test subjects. The study will also be looking for \n indications of protection from tacrolimus toxicity and enhanced \n engraftment survival of the transplanted cells. The trial follows \n extensive preclinical evaluation in animal models.\n \n \n The Phase 1 first-in-human study will evaluate the safety and \n tolerability of AAGP™ PKX-001 treated islets while the Phase 2 component \n will be evaluating the efficacy of adding AAGP™ PKX-001 treated islets \n to the already established Edmonton Protocol.\n \n \n “If the findings translate to the clinic in a manner that reflects \n the preclinical studies, AAGP™ has the potential to substantially \n improve outcomes in patients receiving islet transplants today, and \n future stem cell therapies,” said Dr. James Shapiro, MD, PhD, \n FRCSC, MSM FCAHS, AHS Director of Clinical Islet and Living Donor Liver \n Transplant Programs, Canada Research Chair in Transplant Surgery and \n Regenerative Medicine, Professor of Surgery, Medicine and Surgical \n Oncology, University of Alberta.\n \n \n Dr. \n James Shapiro Bio\n...