The national researchers' meeting of "phase IIa clinical trial of antinotriol injection in the treatment of acute ischemic stroke" was successfully held at the National Clinical Medical Research Center for neurological diseases of Beijing Tiantan Hospital Affiliated to Capital Medical University on the morning of June 2, 2021, and was successfully concluded on the same day.
"Antinotriol injection" is the core R & D product of Sept. The intended indication is ischemic stroke. It is a project supported by the national 13th five year plan for the creation of major new drugs. Phase I clinical trial has been completed in Peking Union Medical College Hospital. The results show that the product has good pharmacokinetic characteristics, good tolerance and high safety. At present, Sept is promoting in an all-round way Phase IIa clinical trial of "antinotriol injection". In order to coordinate the research strength of various clinical units and ensure excellent research quality, this "antinotriol injection" is decided to be held after consultation among the researcher unit, the sponsor and the supervision organization National clinical protocol seminar for researchers. The main expert teams participating in this meeting include the president of Beijing Tiantan Hospital and the research project leader (PI) Professor Wang Yongjun and his research and management team, Lin Suizhen, general manager of Guangzhou saipute Medical Technology Co., Ltd., her R & D management team, CRO, Wu Haibo, chairman of Beijing jingchengtong Medical Technology Co., Ltd. and his team. The other four sub centers of the project participated in the meeting online: Professor song Haiqing and his research team from Xuanwu Hospital of Capital Medical University The research and management team includes Professor Chen Huisheng and his research and management team of the General Hospital of the northern theater of the Chinese people's Liberation Army, Professor Wang Yidong and his research and management team of Sun Yat Sen Memorial Hospital of Sun Yat sen University, Professor Wang Qing and his research and management team of Zhujiang Hospital of Southern Medical University.
Professor Li Shuya of Beijing Tiantan Hospital presided over the meeting. General manager Lin Suizhen, the sponsor, delivered a welcome speech. Professor Li Shuya introduced the phase IIa clinical trial scheme of antinotriol injection and pointed out that this study is a prospective, multicenter, randomized, double-blind, placebo parallel controlled clinical trial of antinotriol injection, aiming to preliminarily explore the treatment of acute cerebral infarction with antinotriol injection Ischemic stroke (AIS) Professor Zhao Xingquan, director of the Department of Neurology of Beijing Tiantan Hospital, introduced the important clinical medical value and innovation of the project. This study focuses on solving the clinical urgent needs of severe patients with large-area cerebral infarction. These patients have developed rapidly, and have lost the opportunity to rescue thrombolysis and thrombectomy, mortality and mortality The disability rate is very high, and effective therapeutic drugs are urgently needed in clinic. At present, there are no reports on clinical trials for this kind of severe patients worldwide, which is extremely challenging. He very much looks forward to antinotriol injection to meet the clinical needs. Then, Professor Liu Yaou, director of imaging department of Beijing Tiantan Hospital, and Dr. Qi Nan, national imaging center, introduced the impact of the project Technical scheme of image acquisition and interpretation.
The experts attending the meeting believed that the sponsor Guangzhou Sept could select such challenging clinical indications, indicating that the sponsor was full of confidence in the efficacy of antinotriol injection. The research units, imaging, statistics and supervision units participating in the meeting said that they would work together with the sponsor to successfully complete this clinical trial of great significance.
Finally, Professor Yan Guangmei, chief scientist of Sept, delivered a concluding speech.