St. Marys, West Virginia
ProtoKinetix, Incorporated (OTCQB:PKTX) (the “Company” or “ProtoKinetix”) (www.protokinetix.com) is pleased to provide the following corporate update to its stockholders:
The management team has been very busy since our last update. The following is a summary of our strategy and action in support of the Company’s direction.
Clinical Trial Application progress:
- Method Development for toxicology studies that were conducted by ITR Laboratories Canada, Inc. (ITR).
- Method Validation for toxicology studies to be conducted by ITR has commenced.
- Molecular study for radiation stabilization has been completed by Iotron Industries Canada, Inc. (Iotron).
- Bio Burden testing and Bio Burden Validation testing that was conducted by Nelson Laboratories, LLC (Nelson Labs) has been completed.
- Certificate of Analysis for Drug Substance (GMP) for AAGP® has been completed by Ambiopharm, Inc. (Ambiopharm).
- AAGP® has been shipped to Iotron to complete sterilization as required by the clinical trial protocols and returned to Ambiopharm.
- A final report of pre-transplant AAGP® treated islet cells analysis prepared by BRI Biopharmaceutical Research, Inc. (BRI).
- We have completed the first draft of the Investigator’s Brochure (IB), a component of the clinical trial application to Health Canada. IB is a multidisciplinary document that summarizes the main elements of an entire development program to date. Although the IB also serves other purposes, it is written to enable investigators conducting clinical trial studies to assess the risks and benefits associated with an investigational product.
We are, at present, preparing a clinical trial application to Health Canada. This trial will be conducted by the Shapiro team at the University of Alberta on the well-established, Edmonton Protocol used for treatment of Type 1 Diabetes through islet cell transplants.
Neural Stem Cell Testing:
- Testing on stem cells transplanted in retina tissue has been completed. This study was conducted at the University of British Columbia (UBC) and directed by Dr. Kevin Gregory-Evans. Stem cells tested with AAGP™ showed a 300% increase in engraftment survival over the control group.
- The results of Dr. Gregory-Evans’ work were published in the Journal of Tissue Engineering and Regenerative Medicine, June 2016.
- We have commenced a major study at UBC under the direction of Dr. Gregory-Evans for the effect of AAGP® in the transplantation of human embryonic stem cells derived from neuronal type cells. This research holds significant potential for the treatment of conditions where neuronal cell death or damage has occurred. This includes age-related macular degeneration (AMD), stroke and spinal cord injury.
“I am extremely proud of how much we have accomplished in these last six months. I look forward to the future for this company that holds so much potential. I am grateful to all of those who have been involved in our progress.”-Mr. Clarence Smith.
We are looking forward to moving ahead with our application for clinical trials this year. We anticipate testing on the effects of AAGP® on the preservation of whole donor organs and tissues for transplantation. We remain very confident in our strategy and appreciate your support of our actions to develop life-saving treatments for disease worldwide and to maximize financial returns to you, our stockholders and friends.
ProtoKinetix, Incorporated 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 company is now preparing a submission 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.
For further information, please contact:
Clarence E. Smith
President and Chief Executive Officer
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 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.