***PKTX.. Folks..I was reading over the PKTX's Annual 10K report. and All I can say is...WoW But WoW.. So many Hot Irons in the Fire dealing with the research on PKTX's molecule ...AAGP.
..Here is just One of the many research projects on going and I'm amazed at all the addition test that were completed on AAGP.. :+)
***The Governors of the University of Alberta submitted an Investigator Sponsored Clinical Trial Application to Health Canada. This trial will be conducted by Dr. Shapiro and his team at the University of Alberta on the well-established, Edmonton Protocol used for treatment of Type 1 Diabetes through islet cell transplants. Subsequent to December 31, 2016, the Investigator Sponsored Clinical Trial Application was approved by Health Canada. In preparation for the Phase 1 / 2 clinical trials as well as for the Clinical Trial Application, ProtoKinetix has: · ..Completed the production of AAGP™ under strict GMP (Good Manufacturing Practice) standards as required by Health Canada and US FDA (United States Food and Drug Administration) for human use; · ..Completed the validated sterilization and vialing of AAGP™ to become the drug product, designated PKX-001, that will be used in the clinical trials at the University of Alberta. · ..Completed stability tests on AAGP™ at different temperature ranges. · ..Completed genotoxicity studies under GLP (Good Laboratory Practice) at ITR Laboratories Canada, Inc. · ..Completed carryover studies, to comply with the clinical test protocols, at BRI Pharmaceutical Research, Inc. · ..Competed PK (Pharmacokinetics) studies at BRI Pharmaceutical Research, Inc. in Vancouver.
...Again..Many Thanks to the Protokinetix's CFO, Susan Woodward, for her hard work in preparing PKTX's Annual 10K.. Thank you!
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