The EG-017Ⅱ Phase II Program Seminar and Launching Meeting was successfully held
Recently, the EG-017 Phase II clinical trial program seminar and kick-off meeting jointly conducted by Beijing New Leading Zhengzhou Deep Blue Sea and Ningbo Xijian Pharmaceutical Technology Co., Ltd. was successfully held in the form of offline main venue (Beijing)+online video conference.
Introduction of EG-017 project
EG-017 is a kind of selective androgen receptor modulators (SARM), which is a newly designed and developed compound based on the mechanism of androgen receptor and cell metabolism. EG017, as a SARM, is intended to treat stress urinary incontinence and other diseases related to middle-aged and elderly people caused by androgen deficiency.
Advantages of the project:
Compared with foreign similar compounds, EG-017 has the same anabolic activity in zoology as foreign countries, but its activity on gonad cells is greatly reduced, which can avoid a great impact on gonads; In the process of animal experiment, the effect of accelerating fat decomposition is better than that of foreign varieties; Toxicological control studies in animals showed that EG-017 was safer. The core active ingredient of EG-017 in vivo has stable structure, so its toxic and side effects are obviously reduced. Its metabolism is mainly eliminated in vitro in the form of hydroxylation and sulfation.
At the beginning of February, 2020, the clinical research approval was obtained.
Phase I clinical study: The first phase of clinical experimental study began in Shanghai Public Health in early April 2020, and all clinical studies have been completed; It is expected that the first-phase clinical report will be completed by the end of November. The study of repeated administration found that the mental state of the subjects improved obviously and the eyes were more moist and bright; Meanwhile, there was no serious adverse events in the whole experiment.
The phase II clinical trial of EG-017 was led by Wang Jianliu, vice president of Peking University People's Hospital. Peking University People's Hospital, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Beijing Hospital, Shanghai First Maternal and Infant Health Hospital, Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine, Wuhan University People's Hospital and Peking University Clinical Research Institute participated in the research.
▲ Wang Jianliu, deputy dean of Peking University People's Hospital
Wang Jianliu, deputy dean of Peking University People's Hospital; Rao Huiying, deputy director of scientific research department of Peking University People's Hospital and head of drug clinical trial institution, and more than 40 main researchers and institutional leaders from six centers, as well as Zhu Xinfa, chairman and director of Ningbo Xijian Medicine, Huang Bin, executive vice president of Beijing New Leading, Liu Kun, executive vice president of contract research organization, Zhu Haobin, medical director of Zhengzhou Shenlanhai, and relevant personnel of the project attended the meeting, which was co-chaired by Lu Xinghong, deputy general manager of Beijing New Leading Zhengzhou Shenlanhai Clinical Division, and Sun Xiuli, director of obstetrics and gynecology of Peking University People's Hospital.
▲ Lu Xinghong (left), deputy general manager of Zhengzhou Shenlanhai, and
Sun Xiuli (right), director of obstetrics and gynecology department of Peking University People's Hospital
This meeting is not only a discussion meeting of EG-017 Phase II clinical trial scheme, but also a kick-off meeting of clinical trial scheme, which is highly valued by project sponsors, contract research organizations and heads of institutions. As Mr. Huang, director of Ningbo Xijian Medicine, said in his speech, the quality of life is closely related to medicines. We should not hesitate to support innovative research and protective treatment, and expect the clinical research of this project to gradually move towards Phase III, get batch numbers and make contributions to mankind.
▲ Deputy Director of the Research Department of Peking University People's Hospital,
Rao Huizhen (left), head of the drug clinical trial institution, and Huang Bin (right), director of Ningbo Xijian Medicine
Subsequently, Dr. Vice President Wang Jianliu, Chairman Zhu Xinfa and the project team actively discussed and put forward their own opinions and suggestions on the specific research scheme of Phase II clinical trial, which greatly improved the confidence of participants. lue Sea Medical Department, elaborated the background information and research scheme of the project in detail, and had a warm exchange with online and offline experts for various discussion points.
▲ Zhu Xinfa (left), Chairman of Ningbo Xijian Medical Technology,
and Zhu Haobin, Medical Director of Zhengzhou Deep Blue Sea (right)
In this EG-017 Phase II program seminar and kick-off meeting, all participants showed strong sense of responsibility, high professionalism and scientific and rigorous work style. I believe that in the upcoming Phase II clinical trial, Beijing New Leading Zhengzhou Deep Blue Sea will work together with researchers from various centers to complete this research with high quality, high efficiency and intimacy in strict accordance with the latest laws and regulations, speeding up the project process and adding a new guarantee for human life and health!
About Beijing New Leading Zhengzhou Deep Blue Sea:
Deep Blue Sea (Zhengzhou) Biomedicine is a well-known brand created by Beijing New Leading in the field of clinical CRO. The company has more than 300 highly professional clinical service teams and has set up resident offices in more than 20 central cities such as Shijiazhuang, Wuhan, Changsha, Hangzhou, Zhengzhou, Shenyang, Dalian and Guangzhou. The company consists of medical department, clinical operation department, data department, quality control committee, pharmacovigilance department, registration department and human genetic resources management committee. Through innovative service mode and multi-dimensional information technology, it can promote the development of clinical research and change the outsourcing service mode of clinical research, and provide customers with diversified R&D support and services, including Phase I ~ IV clinical trials of innovative drugs and generic drugs, bioequivalence (BE) trials of generic drugs, PK/PD clinical studies, in-vivo and in-vitro correlation studies (IVIVR), medical device clinical studies and third-party audits, etc., covering large and small molecular drugs in an all-round way to meet different needs.
At present, the company has established cooperation with more than 400 GCP hospitals in 28 provinces and cities in China, and has cooperated with more than 80 hospitals for more than 5 years, such as Peking University First Hospital, Beijing anzhen hospital, Beijing Fuwai Cardiovascular Hospital, Shanghai Changhai Hospital, Zhongshan Hospital affiliated to Fudan University, jiangsu province hospital, Sino-Japanese Friendship Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, Guangdong Traditional Chinese Medicine Hospital and First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine.