ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB:PKTX) today announced reaching the midpoint 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. All six patients were recruited and treated under this protocol. All primary safety objectives have been achieved at the midpoint in all study participants. As such, the protocol will now be amended to increase the number of participants in the trial with additional secondary objectives added including dose escalation to establish optimization criteria for efficacy testing. In order to satisfy the increased demand for the ongoing clinical trials and expanding research collaborations, the Company has ordered an additional 200 grams of GMP grade PKX-001 molecule. This represents the most significant scale-up of manufacturing in the Company’s history. Request for approval of the amendments will be submitted to Health Canada by the sponsor, the University of Alberta.
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
“We found this anti-ageing glycopeptide (AAGP®) compound to have surprising efficacy in our preclinical testing with human islets. Working with ProtoKinetix we have been able to rapidly move forward to early pilot clinical testing in patients. Thus far, the treatment has proved to be remarkably safe, and we are now in the process of increasing the dose with the goal being to substantially improve islet engraftment and survival in our islet transplant patients. We are especially excited about this trial!” – Dr. James Shapiro
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 human test subjects. The clinical trials primary objective is the establishment of patient safety. The study will also be make 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).
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, organs, 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.
For more Company information and to join our email listing visit our website at ProtoKinetix.com.
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 March 12, 2019. 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.
Clarence E. Smith
President and Chief Executive Officer