Ammendments to ProtoKinetix AAGP® Protocol for Continuation of Phase 1 Human Trials Have Been Approved by Health Canada

MARIETTA, Ohio--(BUSINESS WIRE)-- ProtoKinetix Inc., (www.protokinetix.com) (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today announced that Dr. James Shapiro has received approval from Health Canada and the University of Alberta Ethics Committee for the ammendments to the clinical trial protocol. This phase of the clinical trials, based on safety data received from the initial studies in Phase 1, demonstrated the safety of the molecule and are now approved to adjust the protocols for optimal efficacy. The Company has been asked to deliver over 75-grams of the PKX-001 to the University to accommodate the ongoing clinical trial.

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 informed patient participants. The clinical trials primary objective is the establishment of 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 excited to continue our trials with ProtoKinetix and their anti-aging glycopeptide product in clinical islet transplantation. Our previous studies suggested this powerful agent could improve islet engraftment and protect islets from the toxic side effects of some of the anti rejection drugs. This trial is designed to test that. We eagerly await enrolment of our next patients.” – Dr. James Shapiro

Dr. James Shapiro Bio
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

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About ProtoKinetix, Incorporated

Cautionary Note Regarding Forward-Looking Statements

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.

This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States.

Contacts

Clarence E. Smith
President and chief executive officer
Telephone: 740-434-5041
Email: csmith@protokinetix.com
Twitter: @ProtoKinetix

 
 

Source: ProtoKinetix, Incorporated

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