echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > The therapeutic effect of chlorogenic acid for injection in phase I clinical trial exceeded the researcher's estimate

    The therapeutic effect of chlorogenic acid for injection in phase I clinical trial exceeded the researcher's estimate

    • Last Update: 2018-03-17
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: R & D guest 2018-03-17 participated in the phase I clinical trial of chlorogenic acid for injection, all of the subjects were high-grade malignant glioma patients who had failed to respond to international standards such as surgery, radiotherapy and chemotherapy The results of phase I clinical trial showed that chlorogenic acid injection was safe, with very low side effects, clear drug route and no accumulated toxicity, and the therapeutic effect exceeded the researcher's prediction The median overall survival time of relapsed patients who failed in the classical treatment was at least 2-5 times longer than that of internationally recognized patients Changsha, China - on March 17, 2018, at the second China glioma conference held in Changsha City, Professor Li Wenbin, director of brain glioma Department of Shijitan Hospital Affiliated to Capital Medical University, disclosed in the report that the phase I clinical trial of chlorogenic acid for injection developed by Sichuan Jiuzhang Biotechnology Co., Ltd for the treatment of malignant glioma has been completed, and the data of clinical trial results are accumulated Extremely Malignant gliomas are the most common intracranial tumors High-grade gliomas (grade IV) are the most malignant gliomas The incidence rate is 3.2/100000 The median survival time is 14.6 months from initial diagnosis to death The data have not been updated in the past 20 years Almost all patients with high-grade glioblastoma (grade IV) are treated with the most active treatment Formula (including surgery, radiotherapy and chemotherapy) will inevitably recur in the later stage The median total survival time of the patients with grade IV glioblastoma after recurrence is about 7.2-9.6 months, while the total survival time of the patients who failed in the classical treatment such as temozolomide, bevacizumab or salvage chemotherapy is only 3-5 months (data source: Science on February 28, 2018) Translational medicine (pellegatta s, et al SCI transl MED), targeting fatal brain tumors! Car-t cell therapy, a new target, shows strong therapeutic advantages The clinical team led by Professor Li Wenbin focused on the therapeutic effect of chlorogenic acid for injection on high-grade glioblastoma based on the study of safety, tolerance and pharmacokinetic characteristics All the subjects involved in the phase I clinical trial of chlorogenic acid for injection were high-grade malignant glioma patients who had no effect (disease progression) after international standards such as surgery, radiotherapy and chemotherapy The results of phase I clinical trial showed that chlorogenic acid injection was safe and had very low side effects (the side effects were only muscle induration caused by long-term injection); the drug route was clear and there was no accumulated toxicity; the therapeutic effect exceeded the researcher's prediction In the effective dose group, as of March 2, 2018, the median total survival period (randomization is the calculation date of the first day of treatment) of the subjects was 10.3 months, and the median total survival period (calculation date after recurrence) was 14.2 months Since the median overall survival time of 50% of the cases has not yet been reached, the surviving subjects are still in continuous follow-up The median overall survival time of the relapsed patients who failed in the classical treatment after the injection of chlorogenic acid is at least 2-5 times longer than the internationally recognized In the latest follow-up (February 26, 2018), it was found that the treatment evaluation of subjects with continuous medication showed complete remission (Cr, all lesions disappeared) and partial remission (PR, lesions shrunk by more than 50%), which was encouraging At present, in the global scope, patients with relapsed advanced glioma who fail in standard treatment will be in the irreversible state of "sd-pd-death" (that is, patients will go from disease stable SD to disease progression PD to death, which is currently no drug can be reversed), almost no CR or PR will occur; in clinical practice, it is also found that chemotherapy drugs, such as PCV (cyclohexane The combination of nitrosourea, mbz and vincristine did not prolong the survival period, even though it could reduce the tumor volume in a small number of patients in the early stage In this trial, Cr and PR appeared in the subjects, and the subjects' living conditions were good, and the survival period was significantly prolonged This curative effect response far exceeded the researcher's expectation, which was a significant breakthrough progress! Chlorogenic acid is a natural small molecule active substance with a molecular weight of 354.31, which widely exists in various plants In 1897, it was first discovered by British scientists in sunflower plants; in 1909, it was named chlorogenic acid; in 1947, it was confirmed that the structure of chlorogenic acid was a polyphenol formed by the condensation of caffeic acid and quinic acid Since 2000, Jiuzhang biology has carried out systematic research and development on chlorogenic acid under the leadership of chairman Zhang Jie In 2002, it achieved industrial extraction, isolated sensitized plant protein, and completed the transformation from chlorogenic acid extract to chlorogenic acid API On August 30, 2013, it obtained CFDA approved clinical trial approval for chlorogenic acid injection and API (2013l01855, 2013l01856) Up to now, nine chapters of biology have obtained 23 invention patents related to chlorogenic acid, 1 utility model patent and 2 U.S patents, 27 domestic patents and 26 international patents entering the stage of real examination In December 2016, phase I / II clinical study of the first class I new drug chlorogenic acid for injection was listed by the national health and Family Planning Commission and the Ministry of science and technology as a major new drug creation project of the 13th five year plan, which is also a major scientific and technological support project of Sichuan Province Jiuzhang biology has established a strategic partnership with the Institute of medicine of the Chinese Academy of Medical Sciences, and has conducted in-depth research on the mechanism of antitumor action from multiple levels The research results show that chlorogenic acid for injection is a new type of natural drug with small molecules of antitumor immunity, which mainly plays an anti-tumor role from the two levels of relieving immunosuppression and inducing tumor cell differentiation On the one hand, it can target to regulate the immune checkpoint, relieve the immunosuppression, and promote the proliferation of CD4T lymphocytes On the other hand, it can induce the differentiation of malignant tumor cells, so that they can change from the low differentiation state with a high degree of malignancy to the high differentiation state with a low degree of malignancy Especially in the non clinical and clinical studies of malignant brain glioma, it is found that chlorogenic acid for injection can penetrate the blood-brain barrier, regulate the proportion of immune cells in the focus, promote M1 macrophages that help to eliminate tumor cells to gather in the focus, inhibit M2 macrophages that help tumor cells to migrate and proliferate, and then inhibit the metastasis and proliferation of brain glioma, the relevant basis The research results have been published in scientific reports (Xue n et al 2017; 7:39011) The mechanism of chlorogenic acid for injection promoting apoptosis and inhibiting tumor growth was discussed in detail The results of pharmacodynamics and mechanism study show that chlorogenic acid injection has broad spectrum in anti-tumor It can be applied to a variety of cancer treatment, such as lung cancer, prostate cancer, cervical squamous cell carcinoma, lymphoma and colorectal cancer In view of the broad-spectrum anti-tumor effect of chlorogenic acid injection, Jiuzhang biology launched the IB / IIA phase clinical trial for advanced lung cancer patients while carrying out phase II clinical research on the treatment of recurrent high-grade glioblastoma The research and development of glioma drugs is a difficult problem in the global drug research and development, and no new drugs have appeared in the past 20 years Zhao Jizong, academician of Beijing Tiantan Hospital Affiliated to Capital Medical University, said in an interview with China Medical Information: glioma is a very important part of Neurosurgery tumors, accounting for more than half of brain tumors At present, the precise research will provide new technology for the pathogenesis, diagnosis and treatment of gliomas, and play an important role in the treatment of gliomas The phase I clinical trial results of chlorogenic acid for injection not only proved its safety, but also increased the survival time of patients with recurrent glioma by 2-3 times As a research project supported by major national new drug projects, phase I clinical results have been highly concerned by experts at home and abroad as soon as they are published People from all walks of life are looking forward to the results of further clinical trials If the results of follow-up trials further prove their effectiveness, it will be a great boon for the patients with brain gliomas all over the world Chlorogenic acid injection for injection will probably become a blockbuster class innovative drug from China and improve China's position in global drug innovation Sichuan Jiuzhang biotechnology Sichuan Jiuzhang Biotechnology Co., Ltd., founded in 1999, is a high-tech enterprise integrating scientific research, production and sales, which is dedicated to the comprehensive research of natural active products screening, molecular structure transformation and related applications After a long-term and in-depth pharmaceutical and clinical research, the company, for the first time in the world, developed chlorogenic acid monomer as a drug and applied it to the treatment of major diseases (cancer) In 2013, it obtained the clinical approval (approval No 2013l01856 and 2013l1855) of chlorogenic acid API and preparation issued by CFDA and registered as 1.2 chemicals.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.