PBI Manufacture Core

University Of California, San Francisco, San Francisco CA

Investigators

Linked publications & trials

Abstract

This program project envisions running two small proof of concept phase I clinical trials in human subjects.[unreadable] To facilitate the work of this program project grant, Pathologica will be responsible for all aspects of the[unreadable] manufacture, quality control, and quality assurance required to produce an investigational new drug. This[unreadable] component includes, the manufacture of the compound(s), packaging of the drug(s), stability testing,[unreadable] production of clinical investigator brochures, and filing of the INDs for both trials. The first trial is envisioned[unreadable] to involve the polyamine biosynthesis inhibitor PA-001 in the setting of HIV associated dementia and related[unreadable] syndromes. PA-001 has shown excellent activity against SIV encephalitis in rhesus macaque model (see[unreadable] Project 2: Animal model studies for more details). The compound for the second trial will be chosen based[unreadable] on the results of the in vitro and animal studies performed during the first two years of the program project,[unreadable] but will also be a polyamine biosynthesis inhibitor. Pathologica LLC is fortunate to have rights to evaluate[unreadable] and commercialize many PBIs including the polyamine analog CG47, and the PBI manufacture core will[unreadable] ensure that sufficient quantity and quality of these polyamine analogs will be available for comparative[unreadable] studies with PA-001 as described more fully in Projects 1 and 2 of this program project grant. To provide the[unreadable] drugs Pathologica will be assisted by Dr Fredrick Johnson, who has more than 20 years of experience in the[unreadable] manufacture and quality assurance testing of both small molecule and biological pharmaceutical products.