***PKTX.. ProtoKinetix’ 2nd Quarter Scientific Update 9:30 AM ET, 07/14/2016 - Business Wire
ST. MARYS, W. Va.--(BUSINESS WIRE)--Jul. 14, 2016-- (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:
1. Method Development for toxicology studies that were conducted by ITR Laboratories Canada, Inc. (ITR).
2. Method Validation for toxicology studies to be conducted by ITR has commenced.
3. Molecular study for radiation stabilization has been completed by Iotron Industries Canada, Inc. (Iotron).
4. Bio Burden testing and Bio Burden Validation testing that was conducted by Nelson Laboratories, LLC (Nelson Labs) has been completed.
5. Certificate of Analysis for Drug Substance (GMP) for AAGP™ has been completed by Ambiopharm, Inc. (Ambiopharm).
6. AAGP™ has been shipped to Iotron to complete sterilization as required by the clinical trial protocols and returned to Ambiopharm.
7. A final report of pre-transplant AAGP™ treated islet cells analysis prepared by BRI Biopharmaceutical Research, Inc. (BRI).
8. 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:
1. 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.
2. The results of Dr. Gregory-Evans’ work were published in the Journal of Tissue Engineering and Regenerative Medicine, June 2016.
3. 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.