At some point in human history, someone figured out that Solanum nigrum Linn, a black-berried plant that grows in loamy soil in Pakistan and elsewhere, can help treat an enlarged liver.
An enlarged liver signals that it is diseased, be it from cirrhosis, hepatitis or cancer.
A biotech development company believes it has a medication derived from this plant to treat the most common type of liver cancer.
Q BioMed has received Orphan Drug Designation from the FDA to develop a unique liver cancer medication based on the leaf extract from S. nigrum Linn. Q BioMed acquired the technology in 2017 from the Rajiv Gandhi Centre for Biotechnology in India and the Oklahoma Medical Research Foundation.
In 2016, the Rajiv researchers and colleagues reported that in animal models, a compound now called uttrocide B was 10 times more toxic to HepG2 liver cancer cells than the lone liver cancer medication on the market. This compound attacks those molecules that keep the liver cancer cells alive.
The FDA gave Q BioMed its orphan designation in late January to treat hepatocellular carcinoma, or HCC, the most common type of liver cancer. The FDA grants orphan designation for drugs in development intended to treat a rare disease. If there are fewer than 200,000 people with the disease it is considered rare, like liver cancer.
According to the CDC, about 34,000 people are diagnosed with liver cancer in the US each year and around 27,000 will die each year. Because survival rates are so poor for liver cancer the search for a better treatment is a priority.
People with chronic liver diseases, those who have had hepatitis B or C, people with fatty liver or who drink excessive amounts of alcohol are most at risk for HCC.
Being overweight and smoking are also risk factors.
When liver cancer is suspected the lab tests and scans (CT, MRI) of the abdomen are performed and then a liver biopsy is often the final step in diagnosis.
Current treatment options include:
- Surgery to remove the part of the liver where the cancer is located. This is an option for people with early-stage liver cancer.
- Liver transplant may be an option for patients whose cancer involves most of the liver and has not spread outside of the liver.
- Using heat or cold to destroy cancer cells . These therapies may be an option for people for whom surgery is not a good option.
- Chemotherapy or radiation that is delivered by a tube into the liver right to the cancer cells. Liver cancer does not respond well to chemotherapy and radiation therapies.
- Another type of radiation therapy is an option if surgery is not. This type focuses several beams of radiation simultaneously to the liver.
- Targeted drugs that are designed to attack specific weaknesses in the cancer cells to help slow the disease in people with advanced liver cancers.
- Immunotherapy that involves drugs designed to boost the immune system to attack cancer cells; this treatment is also for those with advanced liver cancer.
When considering treatment for liver cancer the severity of disease and size of the tumor are important factors. But even with these therapies the outcomes are disappointing.
Robert Derham, VP, Portfolio Management at Q BioMed Inc. told Medical Daily via email that “ what makes uttroside-B novel is its unique safety profile combined with impressive efficacy.”
Q BioMed still has to take the medication through human clinical trials. The ODD does not fast-track the process. All the safety requirements must be followed.
What orphan designation does is let these companies get quicker access to meetings with FDA regulators. “[That] can speed up the development process and make the product available faster than it would have been without orphan designation,” said Mr. Derman.
“Preclinical testing is now underway to support an FDA Investigational New Drug (IND) application expected” to be filed this year, Mr. Derman said. Animal testing, often with mice, is required by the FDA prior to the investigational drug application. If the FDA accepts the preclinical trial results, its approval of the investigational drug application will allow Q BioMed to begin clinical trials in humans.
Plant-based cancer treatments
The use of plants to treat cancer and other diseases is not new. For centuries people have used herbs to treat numerous conditions. Recent research has indicated that including certain foods in the diet can help with prostate cancer.
Mistletoe extracts are approved drugs in some European countries. In German-speaking countries mistletoe extracts are used by cancer patients. Some countries limit the use to palliative care and in other countries it is used by patients for the side effects of anti-tumor therapies. There have been clinical studies that support these effects.
Studies have shown some plants are remarkable in slowing the progress of cancer in animals. Further research is recommended to include more plants, their active compounds, and how they work against cancer.
Researchers have found that many different compounds found in plants are very effective in treating a variety of cancers.
But, said Adam Burgoyne, MD, PhD, assistant clinical professor of Medicine,| Division of Hematology/Oncology, Moores Cancer Center, University of California, San Diego Health, a patient or anyone else should not assume that plant-based medications will cause fewer side effects than other medications. That is not necessarily true, he said via email. The best way to determine side effects is by conducting a clinical trial.”
Mr. Derham said that a trial lasting 6-9 months would provide good data on how well uttroside-B attacks cancer cells and how safe it will be for cancer patients.
Yvonne Stolworthy MSN, RN graduated from nursing school in 1984 and has spent many years in critical care and as an educator in a variety of settings, including clinical trials.