Yale-based Research in Landmark Study that May Lead to First FDA-Approved Traditional Chinese Medication for Liver Cancer

Mar 14, 2020 | Alternative Medicine, Cancer, Chinese Medicine, Oncology, Traditional Chinese Medicine, Yale

Yale-based Research in Landmark Study that May Lead to First FDA-Approved Traditional Chinese Medication for Liver Cancer

Yale pharmacology Professor Yung-Chi Cheng, a leader in drug development for hepatitis B, cancer, and HIV has been pursuing a radical idea of unlocking the therapeutic potential of traditional Chinese medicine for over two decades. Put simply, he sought to design botanical drugs that would make traditional cancer treatments work better. Through decades of trials and tribulations, he has arrived at a landmark moment in cancer research. He and Yale-based research partners are launching the first international clinical trial for a botanical drug known as YIV-906. The study will occur at elite research institutions in America, Taiwan, and China. Investigator Cheng has set up a biotech called Yiviva to make it happen. The biotech raised $5 million in 2018 and seeks to change drug development history.

The Drug

The drug is known as YIV-906 and has been transferred to a biotech company called Yiviva that has been set up to commercialize the drug. The name originates from a combination of Chinese and Spanish, meaning “long live medicine.” The underlying Chinese medicine is based on an 1,800-year-old formula for stomach ailments to help fight cancer reports Ms. Brita Belli, writing for YaleNews.

It Started Nearly Three Decades Ago

Back in 1993, Shu-Huey Liu started working in Cheng’s Yale lab as a postdoctoral researcher. By 1997, Cheng and his student started looking into his long-time interest in traditional Chinese medicines. Cheng told Liu that at the time, he thought “it could be the future of medicine—especially in cancer.” Although Liu was a chemist, Cheng thought both could contribute to his research interest. Liu spent many hours studying “Sterling’s collection of ancient Chinese texts, tracing the properties of Chinese herbs” reports Ms. Belli.

Cheng established some focused criteria, including those Chinese herbs still in use, ones that are not rare and had four or fewer elements. Liu was able to come up with around 20 formulations, including the 1,800-year-old treatment for stomach ailments known as Huang Qin Tang—which consists of licorice, dates, peonies, and skullcap—and traditionally used as a basis for tea.

Study in Mice

The team found that the traditional medicine had a high inhibitory property against the debilitating side effects of chemotherapy drug CPT-11 (later approved as irinotecan). The team developed a drug based on the formula and test it on a thousand mice.

Finding

Now called YIV-906, the team found in the study that the drug reduced the toxic GI side effects of the chemo drug, but also enhanced irinotecan’s anti-tumor activity. This latter point represented a major discovery that revealed the powerful therapeutic potential of YIV-906.

More Studies

Cheng’s Yale-based team conducted years more of YIV-906-based testing on a range of cancers—from liver and pancreatic to colorectal—in multiple human studies involving over 200 patients. Cheng found, again and again, positive results. Not only did the drug diminish key side effects of chemo drugs and radiation therapy—but it appeared to lead to a stabilization of cancer, faster recovery, and longer survival rates.

‘WE Medicine’

Recently, the term “WE Medicine” surfaced with the Yale team denoting the combination of Western and Eastern medicine. The results and associated interest was gaining significant momentum. By 2019 Cheng and his research partners conducted a Yale-based study with professor Lieping Chen, a Yale immunology professor. They sought to test YIV-906’s effectiveness with Chen’s immunotherapy drug anti-PD1 and discovered that YI-906 enhanced the immunotherapy drug’s anti-tumor property. As reported by Ms. Belli of YaleNews, the combination both eradicated the mice’ tumors and precluded new tumors from growing!

The Landmark Study

Now Cheng, through his biotech sponsor, launched the landmark study of YIV-906. An oral form of a spray-dried aqueous extract of the four herbs mentioned—and in use for over 1,800 years for a variety of gastrointestinal symptoms from diarrhea and nausea to vomiting, the study seeks to assess YIV-906’s synergistic anticancer activities as well as GI toxicity reduction to cancer patients, including those on sorafenib (chemotherapy). The study investigates the efficacy and mechanisms of YIV-906 as an adjuvant to sorafenib in the treatment of patients with Hepatitis B(+)-associated advanced hepatocellular carcinoma.

The Phase II study will include a target of 125 participating patients at 20 research sites in the United States, Taiwan, and Mainland China. Prominent sites include Memorial Sloan Kettering and Northwell Health Cancer Institute in New York, Taipei Medical University, the National Cancer Center of China, and Queen Mary Hospital in Hong Kong as well as the Chinese Academy of Medical Sciences Cancer Hospital in Beijing, China. The study commenced January 2020 and will run through till June 10, 20201.

‘Lewis and Clark’ With No Map

Jon Soderstrom, managing director, Yale Office of Cooperative Research began advising Cheng in 1996 and notes, “He is a pioneer”, continuing, “He is the Lewis and Clark going into the Pacific Northwest without a map. By the sheer force of his personality and his empirical results, he made people pay attention to this space.”

Big Pharma Watching

Apparently, big pharma is watching from the sidelines but are obviously cautious and, according to researcher Liu, would not “jump in” until they secured an approval.

Changing Human History

Frankly, the approval of this drug could change the course of drug history as we know it. Emphasizing the magnitude of this progress, Liu, now a member of the sponsor Yiviva, noted that Dr. Cheng pointed out to her, “If we get the first Chinese medicine approved as an FDA prescription drug it will change human history.”

About the Sponsor

Founded by Cheng, Liu, and Peikwen Chen (CEO), Yiviva seeks to introduce pioneer, a new paradigm of poly-chemical, multi-targeted medicines to treat complex, aging-associated disease, with a focus on cancer, chronic, and inflammatory diseases. With an overarching mission to help patients live healthier lives by treating the underlying causes of complex diseases and improving the overall quality of life, they seek to change human history.

Founded by Yale University researchers in 2014, the New York-based venture raised $5 million from two investors in 2018. According to Pitchbook, the investors included the Yale Enterprise Institute and Entrepreneurship Lab Bio & Health Tech New York.

Lead Research/Investigator

Yun Yen, MD, Ph.D., Taipei Medical University

Ghassan Abou-Alfa, MD, MBA, Memorial Sloan Kettering Cancer Center

Call to Action: Successful results from this study could lead to a first in FDA approvals. TrialSite News will monitor and update those that are interested.

Source: YaleNews

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