...ProtoKinetix (PKTX): Testing Important Diabetes Drug for Health Canada
..Stephen L Kanaval ... Monday, 01 August 2016 11:25 (EST) ....In April of this year, ProtoKinetix, Inc. (PKTX) took steps to be complete a clinical trial in Canada.
..The clinical trial was for the application of AAGP™ to treat type1 diabetes. The results got a write-up in the American Diabetes Association.
....The company is now preparing an application to Health Canada, which will be test by Dr. James Shapiro at the University of Alberta. ..In a recent company update, ProtoKinetix gave this list of updates on the company’s progress on pushing their products forward (taken from the company press release):
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.