Tag Archive: FDA

  1. Yale biotech startup receives Innovation Award

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    Buoyed by its recent reception of the Innovation Award at the US-China Health Summit, Yale biotechnology startup Yiviva is forging ahead in its work with botanically-derived drugs.

    Yiviva primarily develops a substance called YIV906, which is an herbal mixture based on 1800-year old Chinese formulae. The development of this mixture was based on the research of Yale pharmacology professor Yung-Chi Cheng. Through various clinical studies, YIV906 has been shown to reduce the harmful side effects of chemotherapy and increase the efficacy of cancer therapies. These results and years of research at the Yale School of Medicine helped Yiviva win the Innovation Award at the US-China Health Summit on Sept. 4 in the Chinese city of Xi’an.

    “Our new paradigm for drug discovery is to revisit history and rediscover new medicines,” Cheng said. “Chinese medicine happens to have many of the polychemical, poly-target, holistic characteristics we are interested in.”

    Shwu-Huey Liu, a medical school researcher and Yiviva co-founder, said she was working with Cheng when his lab first began investigating the possibility of using traditional Chinese medicines to increase the efficacy of chemotherapy. She added that Cheng has previously been involved in the development of important drugs for hepatitis B and HIV/AIDS and in the past biotech ventures relating to cancer treatment.

    Liu also said that the researchers’ initial investigation went through over 20 formulations before finding YIV906, an herbal combination known in China as huang qin tang, to be the most effective in treatment. The YIV906 substance had previously been noted to treat gastrointestinal problems, according to Liu.

    Wing Lam, an associate research scientist at the medical school, said that eight clinical trials investigating the effects of YIV906 treatments on colorectal, liver and pancreatic cancer have been conducted or are in progress across the United States, Taiwan and Hong Kong. Patients treated with YIV906 have been shown to experience reduced vomiting, nausea and diarrhea as well as increased survival rates, according to a 2012 study published in the Journal of Ethnopharmacology.

    “Yiviva is a commercial vehicle to explore these ideas,” Cheng said. “The recognition of our company’s drug development technology [at the US-China Health Summit] says something about the value out work has.”

    Peikwen Cheng, a co-founder of Yiviva, said that the attendees at the US-China Health Summit included Chinese ministers of health, researchers, industry professionals, regulators and entrepreneurs.

    He described the competition as an important platform from which to connect with fellow entrepreneurs and the health care community in the US and China.  He added that conversations which had taken place at the conference could spark future collaborations.

    The company hopes to continue to use its drug discovery platform, which is able to screen across multiple pathways of the body, as well as its pioneering techniques in ensuring the consistency of herbally-derived extracts, to continue to tackle age-associated diseases, according to Liu.

    Cheng added that the company faced regulatory obstacles in addition to scientific challenges, noting the dearth of botanical drugs previously approved by the FDA.

    “I started other companies in the tech space, and I think the biggest difference that a pharmaceutical company faces is the time, resources and regulatory pathway required,” Cheng said.

    Hepatocellular carcinoma, the most common form of liver cancer, has a five year survival rate of approximately 14%.