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ProtoKinetix Outlines Steps to Clinical Trial Application for AAGP™
ProtoKinetix Outlines Steps to Clinical Trial Application for AAGP™.
About this update from Protokinetix, Inc.
[{"type":"text","content":"\n \n ProtoKinetix, Incorporated (OTCQB: PKTX) \n (the \"Company\" or \"ProtoKinetix\") (www.protokinetix.com) \n outlines the steps to be completed for the application to conduct a \n clinical trial in Canada.\n \n \n For the last four years ProtoKinetix has been involved in a \n collaboration with the Laboratory of Dr. James Shapiro, M.D., Ph.D., \n FRCSC, the director of the Clinical Islet Transplant Program at the \n University of Alberta Hospital. The outcome of these extensive tests \n resulted in a publication this February in the prestigious American \n Diabetes Association Journal, Diabetes and a planned submission \n to Health Canada of a clinical trial application (CTA). The CTA, for a \n Phase 1/2 study in patients, will involve the addition of AAGP™ to the \n well-established Edmonton Protocol for islet cell transplants for the \n treatment of type 1 diabetes.\n \n \n Before a CTA can be submitted several rigorous tests and events have to \n be completed.\n \n \n 1. The molecule being tested has to be produced under current Good \n Manufacturing Practice (GMP) guidelines. GMP is an exacting standard of \n production that requires a validated and documented approach for each \n step of the process and a complete provenance for every component.\n \n \n 2. A Pharmacokinetic (PK) analysis with a validated methodology has to \n be completed on the molecule to determine AAGP™’s absorption and \n distribution throughout the human body.\n \n \n 3. The molecule has to be tested for toxicology, including evaluation of \n the genotoxic potential.\n \n \n 4. The end product must be certified as sterile.\n \n \n 5. An Investigator's Brochure has to be prepared incorporating these \n results as well as the Chemistry, Manufacturing, & Control (CMC) \n documentation provided by the GMP facility.\n \n \n The CTA submission will be an Investigator-sponsored application from \n Dr. James Shapiro’s Laboratory.\n \n \n In order to assist the Company in achieving a cost effective and timely \n CTA submission, ProtoKinetix has retained the services of the following \n experts and Contract Research Organizations (CROs):\n \n \n Evelina Rubinchik PhD\n \n \n Dr. Rubinchik is our contracted toxicologist who is organizing the selection \n of nonclinical CROs and management of toxicological studies. Dr. \n Rubinchik...