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Review of key phase I studies of CHA in GBM and prospects for phase II/III clinical trials

    “2018 China BioMed Innovation and Investment Conference” was held in Suzhou International Conference Center on September 18,2018. Sichuan Jiuzhang Biological Science and Technology Co., Ltd(hereinafter Jiuzhang) released a special report entitled“review of key phase I studies of chlorogenic acid (CHA) in GBM and prospects for phase II/III clinical trials”.


    In this report, Jiuzhangscientifically described and analyzed thebiological characteristics, anti-tumor mechanism and phase I clinical studies (safety, pharmacokinetics, and treatment trend) and special cases of CHA in advanced GBM patients; and briefly introduced the phase II/III clinical trial design and future development of CHA in treatment of recurrent grade IV GBM patients.


      Recently,phase I clinical studies of CHA in advanced GBM patientswere successfully finished and Phase II/III studies of recurrent GBM will be in progress. Since 1999, temozolomide has been approved by FDA for the treatment of malignant gliomas, the median overall survival (OS) of the patients from initial diagnosis to death has increased from 12.1 months to 14.6 months. The median OSof patients with relapsed grade IV GBM is approximately 7.2 to 9.6 months. The median OSof relapsed patients with high-grade is only 3 to 4.6 months who had been treated unsuccessfully with standard therapy.So far, this data has not been updated and there has been no novel drugsin the world for18 years.


        In phase I clinical study of CHA, allthe enrolled subjects were high-grade malignant glioma who had been unsuccessfullytreated (or progressive disease, PD) with international standard treatmentincluding surgery, radiotherapy and chemotherapy. After the treatment ofCHA, the median OS(starting with randomized medication) was 9.3 monthsin the recurrent grade IV GBM group, while the median OS in the literature for multiple relapsed grade IV glioma patients Only 3-4.6 months. The median overall survival (starting with randomized medication) of the recurrent grade III GBM groupis still in continuous follow-up.At the follow-up of the phase I clinical trial,one patient experienced complete remission (CR, total lesion disappearance) and one experiencedpartial remission (PR, lesion shrinkage of more than 50%) based on the evaluation of RANO criteria.By September 10, 2018, the median OS (based on randomized medication) of multiple relapsed grade IV glioma subjects was 21.4 monthsin the effective dose group (3.0 mg/kg), and the median overall survival of the grade III GBM groupis still in continuous follow-up. It was proved thatsubjects with multiple relapsed grade IV gliomas in the effective dose group had a high survival benefit rate in phase I trials.


         In addition, the results of phase I data showed that CHA had good safety, the main adverse effects were induration and no other serious adverse effects.


      CHA is a natural substance widely found in plants and was discovered by British scientists in 1897. Jiuzhang has developed CHA monomer as a drug for the first time in the world, conducted systematic preclinical research, and applied it to the treatment of major diseases (cancer). CHA is the first anti-cancer class 1 new drug independently developed by Jiuzhangand possessing world intellectual property rights.


         Chinese Academy of Medical Sciences Institute of Drug Research has confirmed thatCHA is a small natural immune drug with multiple targets, multiple channelsand broad spectrum, which plays an anti-tumor role mainly from relieving immunosuppression and inducing tumor cell differentiation. On the one hand, it can target to regulate immune checkpoints, relieve immunosuppression and promote the proliferation of CD4T lymphocytes. On the other hand, it can induce the differentiation of malignant tumor cells from a poorly differentiated malignant state to a less malignant one. Especially in non-clinical and clinical studies of malignant gliomas, it has been found that chlorogenic acid for injection can penetrate the blood-brain barrier and regulate the proportion of immune cells at the lesion site to promote the elimination of M1 macrophages from tumor cells to the lesions, inhibit M2 macrophages that help tumor cell migration and proliferation, and then inhibit the metastasis and proliferation of gliomas. The basic relative research results have been published in Scientific Reports.


        So far, Jiuzhanghas obtained 28domestic patents related to chlorogenic acidand 8international patents. Moreover, 34 domestic patents and 24 international patents have entered the stage of substantive examination. The phase I/II clinical study of the first class of new drugCHA for injection has been includedin the 13th Five-Year National Science and Technology Major Special Major Drug Creation Project


     Recently, Jiuzhangwill carry out the Phase II/III clinical studies of multicenter in China, led by Beijing Tiantan Hospitalaffiliated toCapital Medical University, and apply for the conditional approval as soon as possible.

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