MARIETTA, Ohio–(BUSINESS WIRE)–#AAGP–ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB: PKTX), a clinical-stage biomedical company, today announced an update to the Press Release of March 24, 2020. The amendments to the clinical trial protocol have been submitted by the University of Alberta to Health Canada for their review. Upon approval from Health Canada and upon final approval by the University of Alberta ethics committee, the Company will be immediately delivering 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 optimixing 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.
Dr. James Shapiro Bio
Dr. James Shapiro Video
About the Edmonton Protocol
Diabetes Research Institue 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
ProtoKinetix is a clinical-stage 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, 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.
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 19, 2020 and a Form 10-Q filed on July 10, 2020. 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.
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. The securities referred to herein have not been and will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or with any securities regulatory authority of any state or other jurisdiction in the United States, and may not be offered or sold, directly or indirectly, except pursuant to an exemption from or in a transaction not subject to the registration requirements of the Securities Act.
Contacts
Clarence E. Smith
President and chief executive officer
Telephone: 740-434-5041
Email: csmith@protokinetix.com
Twitter: @ProtoKinetix