Current status of PDT in the United StatesThis paper by Dr. Gal Shafirstein of Roswell Park acknowledges input by Dr. McFarland. He mentions the TLD1433 NMIBC trial but does not actually use the word "TLD1433"...
https://www.sciencedirect.com/science/article/abs/pii/S1572100023001667 March 2023, 103439
Abstract
The field of photodynamic therapy (PDT) continues to make significant progress in the United States of America (USA). There are currently about 23 recruiting interventional clinical studies designed to evaluate the safety and efficacy of PDT in adult patients, in the USA [1]. Skin cancer and lung cancer are the primary sites with four studies investigating PDT for the treatment of basal cell carcinoma (BCC), one study using PDT to treat non-melanoma skin cancer in patients with solid organs transplant, three evaluating PDT in the treatment of actinic keratosis, and another study aims to treat acne. Three studies evaluating PDT in the treatment of non-small cell lung cancer with pleural disease, two of these studies include malignant mesothelioma, and one targeting locally advanced and metastasis that induce airway obstruction. In other disease sites there is one study that evaluates PDT in the treatment of head and neck cancer, non-muscle invasive bladder cancer, pancreatic cancer, esophageal cancer, anal cancer, prostate cancer or low-grade upper tract urothelial cancer. One study evaluates PDT in the treatment neurofibromatosis type 1, and one study evaluates the safety and feasibility of PDT to sterilize deep tissue abscess cavities.
Several photosensitizers are being used with investigational new drug approval or exemption by the USA food and drug administration (FDA) [1]. The FDA-approved porfimer sodium is being used to treat locally advanced lung cancer or lung cancer with pleural disease, malignant central airway obstruction, malignant mesothelioma, and head and neck cancer. The topical pro-drug, aminolevulinic acid (ALA) is being used to treat BCC and anal cancer, while one study adds 4% imipramine cream to ALA PDT to treat microvesicle particle in the skin. A vascular drug, padeliporfin dipotassium, is being evaluated in the treatment of early-stage prostate cancer and low-grade upper tract urothelial cancer. A ruthenium polypyridyl complex administered by instillation is being evaluated for efficacy in treating non-muscle invasive bladder cancer. Verteporfin is being evaluated for efficacy in the treatment of pancreatic cancer. The safety and feasibility of PDT with methylene blue is being evaluated for sterilizing deeply seated abscess cavities.
Treatment planning and dosimetry are being employed by measuring light dose rate (irradiance) and dose (fluence), as well as singlet oxygen. There is no system that is currently approved for clinical use in the USA. The National Institutes of Health supports about 40 investigators-initiated projects in the USA [2]. Most of these projects focus on developing novel methods to improve the response to PDT. These include advanced treatment planning and dosimetry systems, imaging using photoacoustic or theranostic approaches, combination therapies that utilize PDT to enhance the response to chemotherapy, use of Vitamin D to improve treatment outcomes and employing molecular targeted probes and functional nanoparticles and liposomes.
Acknowledgement: Thanks to Dr. Sherri McFarland for her constructive suggestions and comments.
Conflict of interest: Dr. Shafirstein is a co-inventor of the optical surface applicator and dosimetry system (USPTO 11,344,742, 11,040,217). He acknowledges current service on a scientific advisory board with honoraria and stock options from Lumeda Inc.; receiving grant support from Lumeda Inc.; receiving in-kind contributions from Pinnacle Biologics Inc., and grant support from Johnson and Johnson Enterprise Innovation, Inc.