Abstract
a. The main sensitizer used, Sonoflora 1 (SF1), was supplied by SonneMed LLC, (Marlborough, NH). They have published zebra fish assay data indicat ing no evidence of toxicity. b. To further enhance SPDT therapeutic efficacy, we have developed 2 new sensitizers, SFa and UF. All 3 are chlorin e6 based, and all showed no detect able side effects during multiple animal tests. c. Prior to use in clinical practice, the 3 sensitizers had been tested by The Drug Quality Research Institute, Guangdong Province, China, to verify safety for human use. Tests conducted by the insti tute showed that mice tolerated the sensitizers very well even at dosages 250 times higher than the dose used in our clinic. An official certificate has been issued allowing us to produce and commer cially use our sensitizer as foodstuff. d. Our ultrasound device also had been tested by a government laboratory and found to be safe for human use. e. Colleagues at the Dove Clinic using a similar treatment protocol have also not found any safety problems. f. So far we have used SPDT with various combina tions of SF1, SFa, and UF to treat 81 patients with terminal cancer. We have safely conducted SPDT treatment more than 1000 times. SPDT is almost always well tolerated. The main side effects are (reversible) mild pain in tumor areas, tiredness, and weakness. Compared with chemotherapy and radiation therapy, it has almost no toxicity. SPDT does not induce photosensitive dermatitis, which may occur in conventional photodynamic therapy (PDT). SPDT shows none of the hand and foot syndromes that can occur with molecular target therapeutic drugs.
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