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Menka Khoobchandani, 1, 2 Kavita K Katti, 1, 2 Alice Raphael Karikachery, 1, 2 Velaphi C Thipe, 1, 2 Deepak Srisrimal, 3 Darsha Kumar Dhurvas Mohandoss, 3 Rashmi Dhurvas Darshakumar, 3 Chintamani M Joshi, 3 Kattesh V Katti 1, 2, 4 1Department of Radiology, University of Missouri, Columbia, MO 65212, USA; 2Institute of Green Nanotechnology, University of Missouri, Columbia, MO 65212, USA; 3Dhanvantari Nano Ayushadi Pvt Ltd, Chennai 600017, India; 4Department of Physics, Department of Pharmacology, Department of Biological Engineering, University of Missouri Research Reactor (MURR), University of Missouri, Columbia, MO 65212, USACorrespondence: Kattesh V KattiDepartment of Radiology, University of Missouri, One Hospital Drive, Columbia, MO 65212 USATel +1 573 882-5656Email KattiK@health.missouri.eduPurpose: The overarching objective of this investigation was to investigate the intervention of green nanotechnology to transform the ancient holistic Ayurvedic medicine scientifically credible through reproducible formulations and rigorous pre-clinical/clinical evaluations.Methods: We provide, herein, full details: (i) on the discovery and full characterization of gold nanoparticles-based Nano Swarna Bhasma (henceforth referred to as NSB drug); (ii) In vitro anti-tumor properties of NSB drug in breast tumor cells; (iii) pre-clinical therapeutic efficacy studies of NSB drug in breast tumor bearing SCID mice through oral delivery protocols and (iv) first results of clinical translation, from mice to human breast cancer patients, through pilot human clinical trials, conducted according to the Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (abbreviated as AYUSH) regulatory guidelines of the Government of India in metastatic breast cancer patients.Results: The preclinical in vitro and in vivo investigations, in breast tumor bearing mice, established unequivocally that the NSB Nano-Ayurvedic medicine-gold nanoparticles-based drug is highly effective in controlling the growth of breast tumors in a dose dependent fashion in vivo. These encouraging pre-clinical results prompted us to seek permission from the Indian Government’s holistic medicine approval authority, AYUSH, for conducting clinical trials in human patients. Patients treated with the NSB drug capsules along with the “standard of care treatment” (Arm B) exhibited 100% clinical benefits when compared to patients in the treatment Arm A, thus indicating the tremendous clinical benefits of NSB drug in adjuvant therapy.Conclusion: We have succeeded in clinically translating, from mice to humans, in using proprietary combinations of gold nanoparticles and phytochemicals to develop the Nano-Ayurvedic drug: Nano Swarna Bhasma (NSB), through innovative green nanotechnology, for treating human metastatic breast cancer patients.Keywords: gold nanoparticles, mangiferin, mango peel, Nano Swarna Bhasma, NSB, triple negative breast tumor, pilot clinical |
