Phase IIb clinical trial for the first anti-tumor candidate plant drug "YIV-906" in combination with Sorafeni for the treatment of hepatocellular carcinoma has been launched

Yiviva Inc., a biopharmaceutical innovation company, officially launched the First-Line Treatment IIb Phase Of YIV-906 Co-Solafini for hepatitis B-Associated Hepatocellular Carcinoma (HCC) in early 2020, and welcomed the first participants in March this yearYIV-906 is derived from traditional plant medicine formulations and is a unique new anti-tumor candidate drug developed based on integrated system biology methodsJaundice soup has a strong inhibitory effect on side effects (including diarrhea, nausea, and vomiting) of a chemotherapy drug called CPT-11 (i.elater approved commonly used chemotherapy drug Ilitricon) (Report:J Ethno: Compound jaundice soup can reduce chemotherapy side effects)So they developed yIV-906, a drug based on the drugThe previous data show that YIV-906 can not only enhance the anti-tumor efficacy of Sorafini, improve the congenital and adaptive immune function of the body in the tumor microenvironment, but also protect gastrointestinal cells by relieving inflammation mediated by IL-6, NF-B, COX2, iNOS, and promote the growth of progenitor cells and stem cells by activating the Wnt signaling pathway, thus accelerating the regeneration and recovery of damaged gastrointestinal tissueIn the initial I/IIa clinical trial of YIV-906 and Sorafenib's joint treatment of HCC, an Asian patient with chronic hepatitis B hepatocellular bone metastasis completed 32 months of treatment after which the disease was stable and survived for more than six years" Globally, hepatocellular carcinoma HCC accounts for about 75% of all liver cancer, and in China, HCC accounts for 90% of all liver cancers, more than 70% of which is hepatitis B-associated HCC, but treatment for the disease is extremely limitedTherefore, studies like YIV-906, a systemic therapy based on empirical medicine, are highly anticipated by both cancer patients and medical workers"YIV-906, developed with a new integrated system biology approach, not only demonstrates the protective effect of gastrointestinal tissue in cancer treatment, but also enhances the immune effect of the body in the tumor microenvironment," commented DrEdward Chu, Chair of the Department of Blood Oncology at the University of Pittsburgh (UPMC) School of Medicine and Associate Dean of the UpMC Hillman Cancer CenterThese exciting results provide sufficient support for the rationality and necessity of this large global first-line clinical study, who invited DrYu Yun, former President of Taipei Medical University, as one of the world's lead leaders for the clinical program, commented: "YIV-906 is a precision-designed plant medicine using a cutting-edge approach that combines modern science, bioinformatics and current good production practices (current Good Good Practice, cGMP)The raw material composition is selected according to the expected effect of the complex mixture formed by the combination of medicinal herbs on multiple targetsGiven the safety and effectiveness of YIV-906 in previous studies, and the current urgent need for new liver cancer treatment options, we look forward to the success of this global study and leading the way in the development of new cancer treatment strategiesrandomized, placebo-controlled Phase IIb clinical study to assess the effectiveness and safety of YIV-906 combination solafini in treating hepatitis B-associated HCC patients, as well as their impact on the quality of life of patientsThe clinical study is being conducted at 20 clinical trial centers in the United States, mainland China, Hong Kong and Taiwan, including Memorial Sloan Kettering Cancer Center, Chinese Academy of Medical Sciences Oncology Hospital, Taipei Medical University Hospital and Queen Mary Hospital, Hong KongThe study enrolled about 125 subjects worldwideThe subjects were randomly assigned to either the study group (YIV-906 Gasolafi) or the control group (the placebo Gasolafi)The primary endpoint of the study was progression-free survival, which included measures of drug safety, patient quality of life, and other clinical outcomes (including progresstime, total lifetime, objective remission, and disease control rates)Changes in quality of life will be evaluated using HCC18 and EORTC QLQ-C30 scalesFor more information, visithttps://clinicaltrials.gov/ct2/show/NCT04000737yIV-906YIV-906 (formerly known as PHY906, KD018) is a natural mixture extracted from four herbs in strict accordance with the cGMP specification, inspired by a traditional Chinese medicine formula that has been used for thousands of yearsThe first anti-tumor candidate plant medicine was developed by Professor Cheng Yongqi of Yale University and medical practitionersMedical has YIV-906 intellectual property rights worldwide, including 32 patents related to the use, manufacturing and quality control methodsPre-animal experiments related to YIV-906 were conducted in The Laboratory of Professor Cheng Yongqi of Yale UniversityPreclinical data show that YIV-906 has the function of enhancing the immune function of the body in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protecting the gastrointestinal tract (by acting on pathways such as IL-6, NF-B, COX2 and iNOS) and promoting intestinal tissue repair (by increasing the transmission and activity of the Wnt signaling pathway) Animal studies and early clinical trials have also found that, not only is it that the effectiveness of sorofani in the treatment of hepatocellular carcinoma is enhanced, YIV-906 has great potential to improve the effectiveness of existing cancer therapies for pancreatic, colorectal and rectal cancers Based on these findings, YIV-906 is likely to develop as a platform drug for anti-tumor therapy, combined with a variety of existing anticancer programs, such as chemotherapy, immunotherapy and radiotherapy, to treat different types of cancer YIV-906 has been qualified as an "orphan drug" for hepatocellular liver and pancreatic cancer by the U.S Food and Drug Administration (U.S Food and Drug Administration) At present, medical treatment is in accordance with the FDA regulations and requirements, through the plant medicine channel YIV-906 development, with a view to obtaining market approval In addition to liver cancer, YIV-906 and immunotherapy, chemotherapy and radiation therapy, have significant effects on colon, pancreatic, lung and rectal cancers, zheng Yongqi, of the , said This provides new ideas for late-term or incurable cancer treatment in the future "YIV-906 has the potential to become a platform drug for cancer treatment, improving patient median survival and reducing severe gastrointestinal side effects to zero or trace amounts, which is not possible with Western chemicals alone Is a clinical biotech company co-founded by Yale University with offices in Shanghai, New York, Usain, Usain, usa, and New Haven At its core, it uses integrated systems biology to develop multi-target plant medicines for chronic diseases such as cancer and inflammation Using star, mechanism, and response technology platform developed by Professor Zheng Yongqi's team, the medical team used the biosignaling, mechanism and response technology platform STAR (Signal Transncy, Activity and Response) to quickly screen plant herbs and to control the quality of the drug with the mechanism-based quality control (Mechanism-based Quality Control, Mech QC) patented technology associated with biological activity Professor Zheng Yongqi Professor Zheng Yongqi is a well-known Chinese professor in international academia, an outstanding representative of Chinese biologists in the United States, and the founder of the Chinese Society of Biological Sciences in the Americas He has been engaged in pharmacology, biotechnology, Sino-Western drug development and other research for more than 30 years, in oncology and virology and other remarkable achievements and contributions at home and abroad, known as the pioneer of cancer drug research In addition, Professor Cheng Yongqi launched and chaired the Alliance for the Globalization of Chinese Medicine in 2003 to bring together top research institutions from around the world to promote the globalization of Chinese medicine Professor Zheng Yongqi is a senior professor at Yale University in the United States, anti-hepatitis B virus drug - the inventor of ramifeddine, nearly 12 years, committed to the study of classical Chinese medicine compound, led by the team in international academic journals including Science -translational medicine recently published a series of clinical and basic papers on Chinese medicine author: MedSci Source: MedSci Original