The berry-bearing black nightshade shrub is proving to possess the potency to treat liver cancer, as the compound, Uttroside-B isolated from this plant as part of the path-breaking research programme of the Rajiv Gandhi Centre for Biotechnology (RGCB) here, received orphan drug designation from the FDA of the United States.
The leaves of ‘Manathakkali’, which is a perennial shrub (Solanum nigrum)found in the backyards of houses and along roadsides of Kerala, have immense properties to protect the human body’s largest internal organ from uncontrollable cell growth, says a team of scientists with the RGCB, an autonomous institute under the Department of Biotechnology, Government of India.
Orphan Drug designation supports development and evaluation of new treatments for rare diseases and allows fast track approval of the drug.
The technology patented by Dr Ruby John Anto, a senior scientist at RGCB, and her student, Dr Lekshmi R Nath, has been bought by the US pharma company QBioMed. The technology transfer was done through Oklahoma Medical Research Foundation (OMRF).
Dr Ruby and Dr. Lekshmi isolated the drug molecule, Uttroside-B, from the leaves of the Manathakkali plant.
RGCB Director, Dr Chandrabhas Narayana said the research will prove to be a major breakthrough in treatment of liver diseases, including liver cancer. The first milestone payment from QBioMed has already been received.
The findings are path-breaking, given that the liver which primarily detoxifies food while aiding digestion is found to be increasingly susceptible to cancer in modern times. The malignant disease of the bile-producing organ is estimated to kill no less than 800,000 people annually even as 900,000 new cases are reported every year, he said.
In collaboration with Dr L Ravishankar (CSIR-NIST, Thiruvananthapuram), who has developed a novel method to isolate the compound from Solanum nigrum leaves, Dr Ruby and team are currently studying the mechanism of action of the compound and evaluating its efficacy against fatty liver disease, non-alcoholic Steato Hepatitis (NASH) and liver cancer caused by food toxins.
Dr Ruby said there is only one FDA approved drug available for liver cancer treatment at present. The compound developed by her team is found to be more effective than the one available. Toxicity evaluation in human volunteers has shown that the compound is also effective in treating fatty liver.
Recent results from Dr Ruby’s lab indicate that Chloroquine phosphate, a drug already being used in the clinics against malaria, if repurposed and used in a combinatorial regimen with Uttroside-B can tremendously improve the therapeutic efficacy of Uttroside-B against liver cancer.
The technology has been granted patent by the US, Canada, Japan and South Korea.The research work was published in the Nature group of Journal, ‘Scientific Reports’.