Photobac is a near infrared
photosensitizer (PS) derived from naturally occurring
bacteriochlorophyll- a, with a potential for treating a variety of
cancer types (U87, F98 and C6
tumor cells in vitro). The main objective of the studies presented herein was to evaluate the efficacy, toxicity and pharmacokinetic profile of Photobac in animals (mice, rats and dogs) and submit these results to the United States Food and Drug Administration (US FDA) for its approval to initiate Phase I human clinical trials of
glioblastoma, a deadly
cancer disease with no long term cure. The
photodynamic therapy (
PDT) efficacy of Photobac was evaluated in mice subcutaneously implanted with U87
tumors, and in rats bearing C6
tumors implanted in brain. In both
tumor types, the Photobac-
PDT was quite effective. The long-term cure in rats was monitored by magnetic resonance imaging (MRI) and histopathology analysis. A detailed pharmacology, pharmacokinetics and toxicokinetic study of Photobac was investigated in both non-GLP and GLP facilities at variable doses following the US FDA parameters. Safety Pharmacology studies suggest that there is no
phototoxicity, cerebral or
retinal toxicity with Photobac. No metabolites of Photobac were observed following incubation in rat, dog, mini-pig and human hepatocytes. Based on current
biological data, Photobac-IND received the approval for Phase-I human clinical trials to treat
Glioblastoma (
brain cancer), which is currently underway at our institute. Photobac has also received an orphan drug status from the US FDA, because of its potential for treating
Glioblastoma as no effective treatment is currently available for this deadly disease.