Ammendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials Have Been Approved by Health Canada
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that Dr. James Shapiro has received approval from Health Canada and the University of Alberta Ethics Committee for the ammendments to the clinical trial protocol. This phase of the clinical trials, based on safety data received from the initial studies in Phase 1, demonstrated the safety of the molecule and are now approved to adjust the protocols for optimal efficacy. The Company has been asked to deliver over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial.
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 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 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 excited to continue our trials with ProtoKinetix and their anti-aging glycopeptide product in clinical islet transplantation. Our previous studies suggested this powerful agent could improve islet engraftment and protect islets from the toxic side effects of some of the anti rejection drugs. This trial is designed to test that. We eagerly await enrolment of our next patients.” – Dr. James Shapiro
Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol
Diabetes Research Institute Foundation Canada Video
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
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About ProtoKinetix, Incorporated
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