A radio-pharmaceutical kit to prepare parenteral injections of a multimodal all-organic nanovesicle for "first-in-human" clinical studies in prostate cancer. (#86)
The Porphysome is an all-organic biocompatible nanoparticle that exhibits multiple structurally depend modes-of-action emerging from a single, easily synthesized pyropheophorbide–lipid building block [1]. With over 40 research articles on its biophotonic and therapeutic applications in cancer imaging (e.g., PET, MR, near-infrared fluorescence, and photoacoustic) and treatment (e.g., photodynamic, and photothermal therapies) the Porphysome is an ideal drug candidate for further clinical translation. Towards this end, recent progresses have been made in the development of a radio-pharmaceutical formulation of Porphysomes in preparation for a Clinical Trial Application (CTA). First, the production of Porphysomes with scalable cGMP manufacture and quality control systems has been accomplished in an academic setting. Secondly, a radio-pharmaceutical kit to prepare Porphysomes labelled with radioisotope 64-Copper for PET imaging has been developed with high labelling efficiencies and of a quality suitable for patient intra-venous administration. Thirdly, the pharmacology, systemic and photo-toxicology, and radiation dosimetry profiles of radio-pharmaceutical Porphysomes have been characterized in preclinical models. Lastly, groundwork has been laid in preparation for a clinical study with Porphysomes to enable dual photoacoustic imaging and photodynamic therapy in patients with prostate cancer. The meaningful outcome of these efforts will be the completion of a CTA submission to Health Canada which, if successful, will permit the first-in-human use of Porphysomes.
- Lovell, J.F. et al., 2011. Porphysome nanovesicles generated by porphyrin bilayers for use as multimodal biophotonic contrast agents. Nature materials, 10(4), pp.324–332. Available at: http://dx.doi.org/10.1038/nmat2986.