ProtoKinetix Updates Progress Toward Clinical Trial Application for AAGP™ 10:00 AM ET, 05/12/2016 - Business Wire
ST. MARYS, W. Va.--(BUSINESS WIRE)--May 12, 2016-- ProtoKinetix, Incorporated (OTCQB: PKTX) (the "Company" or "ProtoKinetix") (www.protokinetix.com) is pleased to update its stockholders on the progress that it has made toward the application to conduct clinical trials in Canada with Health Canada.
AmbioPharm, Inc. of North Augusta, South Carolina, has completed the first run of Good Manufacturing Practice (GMP) of AAGP™. AmbioPharm has shipped AAGP™ to ITR Canada of Montreal, Quebec, to commence toxicology studies under the Good Laboratory Practice (GLP).
AmbioPharm has also shipped AAGP™ to Nelson Laboratories of Salt Lake City, Utah, to commence bio burden and development of sterility protocols under GLP.
These above tests will provide critical data for the Investigator’s Brochure (IB), a component of the clinical trial application to Health Canada. The 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.