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ProtoKinetix Achieves Primary Objective Safety at Midpoint of Clinical Trial
ProtoKinetix Achieves Primary Objective Safety at Midpoint of Clinical Trial.
About this update from Protokinetix, Inc.
[{"type":"text","content":"\n \n ProtoKinetix, Incorporated (www.protokinetix.com) \n (the \"Company\" or \"ProtoKinetix\") (OTCQB:PKTX) \n today announced reaching the midpoint of a Phase-1 first-in-human \n clinical trial of AAGP® PKX-001 treated islet cells used in \n conjunction with the Edmonton Protocol for the treatment of Type-1 \n diabetes. All six patients were recruited and treated under this \n protocol. All primary safety objectives have been achieved at the \n midpoint in all study participants. As such, the protocol will now be \n amended to increase the number of participants in the trial with \n additional secondary objectives added, including dose escalation to \n establish optimization criteria for efficacy testing. In order to \n satisfy the increased demand for the ongoing clinical trials and \n expanding research collaborations, the Company has ordered an additional \n 200 grams of GMP grade PKX-001 molecule. This represents the most \n significant scale-up of manufacturing in the Company’s history. Request \n for approval of the amendments will be submitted to Health Canada by the \n sponsor, the University of Alberta.\n \n \n The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS, \n AHS Director of Clinical Islet and Living Donor Liver Transplant \n Programs, Canada Research Chair in Transplant Surgery and Regenerative \n Medicine, Professor of Surgery, Medicine and Surgical Oncology, \n University of Alberta.\n \n \n Dr. \n James Shapiro BioDr. \n James Shapiro VideoAbout \n the Edmonton Protocol\n \n \n \"We found this anti-aging glycopeptide (AAGP®) \n compound to have surprising efficacy in our preclinical testing with \n human islets. Working with ProtoKinetix we have been able to rapidly \n move forward to early pilot clinical testing in patients. Thus far, the \n treatment has proved to be remarkably safe, and we are now in the \n process of increasing the dose with the goal being to substantially \n improve islet engraftment and survival in our islet transplant patients. \n We are especially excited about this trial!\" – Dr. James Shapiro\n \n \n PKX-001 is the designation given to the lead drug product molecule of \n the AAGP® family. Islet cell transplants are well recognized \n as a viable and effective treatment for Type-1 diabetes. The PKX-001 \n study will treat islet cells ...