ProtoKinetix, Incorporated Announces Investigator Sponsored Clinical Trial Submitted to Health Canada for the use of AAGP(TM) in the Treatment of Type 1 Diabetes
9:15 am ET January 17, 2017 (BusinessWire) Print
ProtoKinetix, Incorporated (OTC: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) today announced that the Governors of the University of Alberta have submitted an Investigational Testing Authorization application to commence clinical studies in Canada. This authorization will allow the clinical trial group to enroll Canadian patients into the study.
"Based on extensive experiments in the lab we are clearly excited to take forward the AAGP(TM) molecule from the bench to testing in patients in partnership with ProtoKinetix. This anti-aging glycopeptide molecule has been exceedingly potent in protecting human islets from early damage after transplant from engraftment and anti-rejection drugs in our preliminary tests, and if these promising findings can be replicated in patients in the clinic receiving islet cell transplants today, and potentially stem cells in the future, this would represent a major advance." Dr. James Shapiro, M.D., Ph.D., FRCSC, Director of Clinical Islet Transplant Program, University of Alberta.
Click for Dr. James Shapiro Bio
"It is a remarkable achievement for a small biotech company like ProtoKinetix to be submitting a Clinical Trial Application (CTA) to Health Canada." Julia Levy, PhD, Chairman ProtoKinetix Business and Scientific Advisory Board.
Click for Dr. Julia Levy Bio
"I look forward to the opportunity to prove that AAGP(TM), used in the Edmonton Protocol, will greatly improve results in the treatment of Type 1 Diabetes in humans. I am very pleased that we have met the goals that we set out in January, 2016." Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
About the Edmonton Protocol
About the PKX-001 Study
PKX-001 is the designation given to the drug product molecule of the AAGP(TM) family. Islet cell transplants are well recognized as a viable and effective treatment for T1 diabetes.
The PKX-001 Study will treat islet cells prior to transplantation into human test subjects. The clinical trials will be accessing 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.
ProtoKinetix, Incorporated is a molecular biotechnology company that has developed and patented a family of hyper stable, potent glycopeptides (AAGP(TM)) 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 submitted an Investigational Testing Authorization application to Health Canada to enter into a Phase 1/2 human clinical trial at the University of Alberta. Additional studies will be expanded to include whole organ transplantation and other cell therapies used in regenerative medicine.
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 March 30, 2016. 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 herein.