ST. MARYS, W. Va.--(BUSINESS WIRE)--ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) today announced the start 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 first patient has been treated under this protocol. 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.
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PKX-001 is the designation given to the 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 will be assessing any side effects or physiological damage to the test subjects. The study will also be looking for indications of protection from tacrolimus toxicity and enhanced engraftment survival of the transplanted cells. The trial follows extensive preclinical evaluation in animal models.
The Phase 1 first-in-human study will evaluate the safety and tolerability of AAGP™ PKX-001 treated islets while the Phase 2 component will be evaluating the efficacy of adding AAGP™ PKX-001 treated islets to the already established Edmonton Protocol.
“If the findings translate to the clinic in a manner that reflects the preclinical studies, AAGP™ has the potential to substantially improve outcomes in patients receiving islet transplants today, and future stem cell therapies,” said 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.
About ProtoKinetix, Incorporated
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 used in regenerative medicine. Due to the results achieved over the last four years of testing, the University of Alberta has begun Phase 1/2 human clinical trials at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
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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 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). 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. These forward looking statements are identified by their use of terms and phrases such as “may,” “expect,” “estimate,” “project,” “plan,” “believe,” “intend,” “achievable,” “anticipate,” “will,” “continue,” “potential,” “should,” “could,” and similar terms and phrases. 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. Among these risks are those set forth in a Form 10-K filed on February 21, 2017. It is important that each person reviewing this release understand the significant risks attendant to the operations of ProtoKinetix. ProtoKinetix disclaims any obligation to update any forward-looking statement made here.