ProtoKinetix Announces the Resumption of Phase 1b Clinical Trials for the use of AAGP® Treated Islet Cells in the Treatment of Type 1 Diabetes
ProtoKinetix announced the resumption of Phase I clinical trials for AAGP® (PKX-001) treated islet cells at the University of Alberta, paused due to COVID-19. The trials aim to assess the safety and efficacy of PKX-001 in treating Type-1 diabetes, with the first patient of ten now enrolled in Phase 1b. Initial results demonstrated PKX-001's safety in a previous Phase 1a study. The trials also seek to optimize dosage and evaluate protection from tacrolimus toxicity.
- Resumption of Phase I clinical trials for PKX-001 after COVID-19 pause.
- Initial Phase 1a trials showed safety of PKX-001 treated islet cells.
- First patient enrolled in Phase 1b trial focusing on efficacy.
- Potential implications for other medical conditions beyond Type-1 diabetes.
- None.
ProtoKinetix, Incorporated (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced Phase I clinical trials of AAGP® (PKX-001) treated islet cells have resumed at the University of Alberta, Edmonton. All clinical trials were paused in 2020 due to COVID-19 restrictions in the province.
The Phase 1 trials, conducted by renowned surgeon Dr. James Shapiro, focus on the impact of PKX-001 treated islet cells transplanted into patients suffering from Type-1 diabetes. Data from the initial Phase 1a illustrated the safety of using the patented PKX-001 molecule as an enhancement to transplanted islet cells in six study patients. Study protocols have been modified for Phase 1b, focusing on the efficacy of the PKX-001 treated islet cells transplanted in a process known as the Edmonton Protocol. Under the new protocols, the first patient out of a total of 10 has entered into this Phase 1b trial Type-1 diabetes patients to be treated.
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 study will treat islet cells with PKX-001 prior to transplantation into informed patient participants. The clinical trials primary objective is to establish 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 delighted to have increased dose and reactivated this exciting AAGP® trial, and transplanted our next patient on April 12, 2021. We eagerly await definitive results as we move forward.” – Dr. James Shapiro
Click here for 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. The Islet Cell Transplantation study is encouraging and additionally supports ProtoKinetix’s efforts to develop PKX-001 for other indications, including (but not limited to) stem cell transplantation in Wet and Dry Age-related Macular Degeneration and potential use in Dry Eye Disease. ProtoKinetix aims to investigate PKX-001 for these and other indications based on robust preclinical evidence.
Visit our new website at ProtoKinetix.com for more information and to join our email list.
About ProtoKinetix, Incorporated
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The information discussed in this press release includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included herein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are forward looking statements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not be considered to be) guarantees of future performance. Refer to our risk factors set forth in our reports filed on Edgar. ProtoKinetix disclaims any obligation to update any forward-looking statement made here.
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