Policy & Regulation
ProtoKinetix Achieves Primary Objective Safety at Midpoint of Clinical Trial
11 June 2019 - - US-based molecular biotechnology company ProtoKinetix, Inc. (OTCQB: PKTX) has reached 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, the company said.
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.
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 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).
ProtoKinetix is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP) that enhance both engraftment and protection of transplanted cells, organs, tissues and organs used in regenerative medicine.
Due to the results achieved over the last four years of testing, the University of Alberta has begun Phase 1 human clinical trials.
Additional studies will be expanded to include whole organ transplantation and all therapies that are being developed globally to date; diabetes, retinal degeneration, cardiac repair and many other degenerative conditions. In addition, we are studying the potential impact on several cancer therapies.