ProtoKinetix First in Series of Town Hall Shareholder Meetings Marietta, Ohio, June 7, 2019
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) today announced reaching the midpoint of a Phase-1 first-in-human clinical trial of AAGP™ PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-1 diabetes.
...All six patients were recruited and treated under this protocol. All primary safety objectives have been achieved at the midpoint in all study participants. As such, the protocol will now be amended to increase the number of participants in the trial with additional secondary objectives added including dose escalation to establish optimization criteria for efficacy testing.
...In order to satisfy the increased demand for the ongoing clinical trials and expanding research collaborations, the Company has ordered an additional 200 grams of GMP grade PKX-001 molecule. This represents the most significant scale-up of manufacturing in the Company’s history.
...Request for approval of the amendments will be submitted to Health Canada by the sponsor, the University of Alberta.
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.