<p>New Approaches in Breast Cancer Therapy Through Green Nanotechnology and Nano-Ayurvedic Medicine – Pre-Clinical and Pilot Human Clinical Investigations</p>

Abstract

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.

<p>Gold Nanoparticles as Radiosensitizers in Cancer Radiotherapy</p>

“…Nano Swarna Bhasma (NSB), approved by the Indian government regulatory authority of AYUSH (DNA_SPN_B001_17), has been used in female patients with pathologically confirmed invasive breast cancer stage IIIA or IIIB and showed acceptable safety and excellent efficacy. 215 These studies provide strong evidence for the clinical potential of GNPs. However, as mentioned by the National Cancer Institute (NCI)-Radiation Therapy Oncology Group in translational program strategic guidelines for the early-stage development of radiosensitizers, the clinical transformation of any radiosensitizer is rarely a seamless transition directly from the bench to the bedside.…”

Gold Nanoparticles Synthesized Using Extracts of Cyclopia intermedia, Commonly Known as Honeybush, Amplify the Cytotoxic Effects of Doxorubicin

“…The health benefits of MGF have prompted a rigorous research to find other sources of this valuable compound [ 4 , 5 ]. While the extracts from mango ( Mangifera indica L.) fruit peel [ 6 ], seeds, leaves [ 2 , 7 , 8 ], bark and roots [ 2 , 7 ] have been shown to contain this compound, MGF is also found abundantly in other plant species such as Salacia chinensis , Swertia chirata , Hypericum aucheri and Cyclopia intermedia [ 6 , 9 , 10 ]. The xanthones (MGF and isomangiferin) and flavanones (hesperitin and hesperidin) are the major components of C. intermedia extracts, and are thought to be responsible for most of its pharmacological effects, including anti-diabetic, anti-cancer, anti-obesity, antioxidant and antimicrobial activities [ 11 , 12 ].…”

“…Numerous studies reported on the use of green nanotechnology to synthesize AuNPs from M. indica L. [ 18 , 19 , 20 ] and MGF [ 6 , 9 ]. While MGF is a major phytochemical constituent of the peel of M. indica L., it is not known if MGF is involved in the synthesis of the AuNPs when synthesis is done using a plant extract.…”

Green nanogold activity in experimental breast carcinoma in vivo

“…Combination of gold nano particles with Ayurvedic phytochemical herbs as cinnamon, curcumin, grape , mango….etc. led to innovative green nanoproduct called Nano-Ayurvedic formulations that will be a promising nanotechnology for cancer treatment (5) .…”