How can Chinese scientists push 1,800-year-old Chinese medicine into clinical trials in the United States?

!--webeditor:page"--March 30, 2020 / -- More than 20 years ago, Young-Chi Cheng, a professor of pharmacology at Yale University, came up with a radical idea: What if he could develop ancient Chinese medicine to treat hepatitis B, cancer and AIDS? What if he could design a plant medicine that would make traditional cancer treatments more effective? No one has done that before.
FDA didn't even have a procedure for approving multi-ingredient plant-based drugs until 2004, when the agency issued guidelines for plant-specific drugs.
researchers and drug development experts advised him to change course.
they say the development of plant medicines is too complex and too risky.
but the idea has gained a foothold in Professor Henry Bronson, a professor of pharmacology at Yale School of Medicine, and he has no intention of giving up.
"Chinese medicine works by using a variety of chemicals, as well as the ability of different organs to metabolize them," he said in his office at Yale's Sterling School of Medicine.
his office was full of crooked paper.
" is a whole new paradigm.
i've had a lot of doubts, but I think the results will prove it all.
" Photo Source: Andrew Hurley Now, at a milestone in cancer research, Cheng and his research partners are launching the first international clinical trial of the plant drug YEV-906.
trial involving patients with liver cancer and hepatitis B will be conducted at 20 institutions in the United States, China, Taiwan and Hong Kong, China.
major research sites include memorial Sloan-Kettering Cancer Center in New York and Northwell Health Cancer Institute, Taipei Medical University, China National Cancer Center and Queen Mary Hospital in Hong Kong.
"He was a pioneer," said Jon Soderstrom, director of the Yale Office of Cooperative Research.
"He entered the Pacific Northwest like Lewis and Clark without a map.
his charisma and empirical results, he brought attention to the field.
" Shwu-Huey Liu says major pharmaceutical companies are watching Cheng's progress, and Liu began working as a postdoctoral researcher at Cheng's Yale lab in 1993, when he focused on antiviral and traditional cancer drugs.
"They supervise us and attend meetings," she said, "but big pharmaceutical companies won't step in until we get approval."
, Liu is the co-founder and chief scientific officer of Yeviva, a biotech company in Cheng, which is developing THEV-906.
a combination of Chinese and Spanish words, meaning "longevity medicine."
is a fitting slogan, and the company has revived its 1,800-year-old formula for treating stomach diseases to help fight cancer.
old discoveries -- New Discoveries In 1997, when Liu completed his postdoctoral study, Cheng mentioned his interest in Chinese medicine.
he thinks this could be the future of medicine -- especially in cancer," Liu said.
a chemist with no background in Chinese medicine, but "he thinks we can work together, and my knowledge of chemistry helps with quality control."
" Liu contacted a librarian at Yale's Sterling Memorial Library and was taken to a secluded room on the third floor, where few people visited.
she spent hours rummaged through Sterling's collection of ancient Chinese books, looking for the properties of Chinese herbal medicine.
Cheng told her to look for herbs that were still in use, which were not so rare and contained four or fewer elements.
Liu brought back about 20 recipes.
one of the drugs used to treat stomach diseases is called jaundice soup, which is 1800 years old.
it is a mixture of licorice, dates, peonies and to the heavens, traditionally prepared as tea.
laboratory tests, Cheng's team found that jaundice soup had a strong inhibitory effect on the side effects of a chemotherapy drug called CPT-11 (later approved as Eriticon), including diarrhea, nausea and vomiting.
Cheng and his team developed a drug based on the formula and tested it on 1,000 mice.
their drug, YEV-906, not only reduces the toxic side effects of chemotherapy drugs on the gastrointestinal tract, but also enhances the anti-tumor activity of Iliticon -- a major discovery that reveals the powerful therapeutic potential of YEV-906.
we were surprised to find that treatment not only reduced the side effects of the gastrointestinal tract, but also increased the effects of chemotherapy on tumors," Cheng said.
the rise of "WE" medicine, researchers conducted additional tests on the effectiveness of the drug for a range of cancers, including the liver, pancreas and colorectal, in a number of human studies involving more than 200 patients.
these positive effects are repeated over and over again.
YIV-906 not only reduces the side effects of chemotherapy drugs and radiotherapy, but also stabilizes the cancer, allowing patients to recover faster and survive longer.
2019, Cheng and his research partners, in collaboration with Yale University professor of immunobiology, tested the efficacy of YEV-906 and Chen's immunotherapy drug anti-PD1, and found that YEIV-906 enhanced the anti-tumor properties of immunotherapy drugs.
combination of these drugs not only eradicated all tumors in mice, but also did not grow when new tumors were implanted.
, they wrote in the study, suggest that YEV-906 with anti-PD1 "has produced a tumor-specific vaccine-like effect."
they call this new method "WE" medicine, a fusion of Western medicine and Eastern medicine, which focuses on microscopic and single disease targets, while Eastern medicine cites traditional Chinese therapies as an example.
Cheng says a system-wide approach is needed to fight complex opponents like cancer.
: Yung-Chi Cheng, andrew Hurley, said: "The reason this drug works is because it has a variety of chemicals that can work in multiple places, changing the whole body's balance system.
it triggers congenital and adaptive immunity in the cancer micro-environment.
"!--/ewebeditor:page-- !--webeditor:page"--what they need now is a larger data set.
When the results of international trials are announced about three years from now, YIV-906 may find itself the next in a long list of breakthrough drugs developed from natural products, including aspirin (from willow skins), yew alcohol (from Pacific red bean fir bark), Duffy (from octagonal fennel), artemisinin (a drug extracted from artemisinin to treat malaria, and its discovery).
cheng says it's a long process, but if Cheng and his team succeed, it could lead to a new approach that could be used not only to treat cancer, but also to prevent and treat age-related and lung diseases.
is an untapped potential that people haven't thought about much before," said Soderstrom of Yale University's Office of Cooperative Research.
more than 20 years ago, Liu began studying in his lab, and Professor Cheng has been with her through many periods of entrepreneurship and financial hardship.
Liu says his belief in the huge potential of botany underpins her.
Cheng said, 'If we get the first Chinese medicine approved as a prescription drug by the FDA, it will change human history,'" Liu said.
"I believe him.
" () Reference: 1: Ancient Chinese medicines new possibilities for cancer treatment 2 Yung-Chi Cheng et al. The Four-Herb Chinese Medicine PHY906 Reduces Phyphysy-Induced GastroIntestinal Toxicity. Science Translational Medicine. 2010. DOI: 10.1126/scitranslmed.3001270 (3) Abstract 2252: YIV-906 (PHY906) enhanced Ed anti-tumor activityy of immune checkpoint therapy (Anti-PD1) against liver cancer by changing the tumor micro-environment associated with M1 macrophages !--/ewebeditor:page--.