ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB:PKTX) announces that the Company has taken procession of an additional 200 grams of GMP grade PKX-001 (AAGP(R)) molecule. We are shipping sufficient molecule to Iotron Industries in British Columbia for sterilization. The sterilization process is a 1-week turnaround. After sterilization there will be one more process needed that will take up to 3-weeks for quality assurance. The sterilized molecule will then be sent to the University of Alberta for use in the continuation of the Phase-1 first-in-human clinical trials of PKX-001 treated islet cells used in conjunction with the Edmonton Protocol for the treatment of Type-1 diabetes. We are shipping ample molecule to include another 10-patients in the clinical trials. This represents the most significant scale-up of manufacturing in the Company's history. Upon receipt of the molecule, request for approval of the amendments will be submitted to Health Canada by the sponsor, the University of Alberta. This total process will take 4-6 weeks.
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.
Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol
PKX-001 is the designation given to the lead drug product molecule of the AAGP(R) 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 human test subjects. The clinical trials primary objective is the establishment of patient safety. 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).
To obtain additional information and updates regarding this trial please use the following link: Clinicaltrials.gov - Islet Transplantation Using PKX-001.