Abstract 3138: Mechanism based quality control (MBQC) for the four-herb Chinese medicine formulation, PHY906(YIV-906) and other herbal products
Authors: Lam Wing , Ren Yongshen , Guan Fulan , jiang Zaoli , Cheng William , Liu Shwu-Huey , Cheng YungChi 
Published: July 2017

Abstract
PHY906(YIV-906), a four-herb Chinese medicine formulation, is inspired by an 1800 year-old Chinese formulation called Huang Qin Tang historically used to treat gastrointestinal symptoms. PHY906 can increase the anti-tumor activity of immunotherapy antibodies or chemotherapies while promoting damaged intestinal tissue recovery. Several clinical studies showed that PHY906 had potential to increase the therapeutic index of cancer treatments (chemotherapy, radiation) by prolonging life and improving patient quality of life. When in vivo activities of three different clinical batches (number 6, 10, 11) of PHY906 and F (which is commercial batch of Huang Qin Tang, HQT) was compared to their similarity of chemical profiles, the two set results could not be completely matched. For example, F had very different in vivo activities from PHY906-10 but F clustered closely to PHY906-10 based on their chemical profiles. This information concludes that chemical profile analysis without excluding irrelevant chemicals is not sufficient to evaluate the in vivo activities of a polychemcial mixture. Therefore, we included another two biological platforms based on the in vivo mechanism of action of PHY906 for the quality control. First, we tested the activity of different batches of PHY906 and F on our signaling transduction activity response (STAR) platform which including 18 luciferase reporter cell lines and 2 enzymatic assays. The results of correlation analysis and clustering analysis based on the results from STAR could be matched to in vivo activities of different batches of PHY906 and F. Second, we tested the effect of different batches of PHY906 and F on a set of genes which based on our previous DNA array data in cell culture and the mechanism action of PHY906. Again, the results of correlation analysis and clustering analysis based on qRT-PCR could be matched to to in vivo activities of PHY906 and F. In conclusion, the quality control of a herbal product should be dependent on its usage. Appropriate biological assays based on its mechanism action should be developed for QC for particular usage. Chemical fingerprint has limitation unless irrelevant chemicals had been filter out. Similarity index is only useful when relevant information is used. Mechanism based quality control could be used for other herbal products. This work was supported by grant (1PO1CA154295-01A1) from National Cancer Institute (NCI), NIH, USA. Dr. Yung-Chi Cheng is a fellow of National Foundation for Cancer Research (NFCR), USA.
Citation Format: Wing Lam, Yongshen Ren, Fulan Guan, Zaoli jiang, William Cheng, Shwu-Huey Liu, YungChi Cheng. Mechanism based quality control (MBQC) for the four-herb Chinese medicine formulation, PHY906(YIV-906) and other herbal products [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3138. doi:10.1158/1538-7445.AM2017-3138