Hypoxia-Ischemia, Brain

NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16th World Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Continue Reading Professor Yongjun Wang presented a late-breaking oral presentation at WCS Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

10月24日，先声药业宣布，由北京天坛医院王拥军教授牵头的一项中国多中心随机双盲安慰剂对照的脑卒中新药研究TASTE-2在世界卒中大会（WSC）上以口头报告发表。研究表明，急性缺血型卒中患者在血管内取栓治疗（EVT）前，应用依达拉奉右莰醇进行脑细胞保护，显著改善了患者90天时神经功能独立的患者比例。这一结果的发表，有望支持依达拉奉右莰醇作为卒中取栓的联合治疗，在取栓前应用，提升患者卒中后功能恢复的疗效。 据《中国脑卒中防治报告（2023）》显示，在中国年新发卒中患者中，急性缺血性脑卒占比约70%，而其中又有约四成患者属于大血管闭塞型卒中。这一卒中亚型起病凶险，致残、致死率更高。血管内取栓术（EVT）是近年来再灌注治疗的重要进展，可为约70%~90%的大血管闭塞型卒中患者实现血流再通，但只有近一半的患者功能恢复良好，仍有相当比例取栓患者在治疗90天后存在不同程度的残疾。 根据国际“卒中治疗学术界圆桌会议 ”（STAIR）的建议，脑细胞保护剂可减少缺血性脑损伤，尤其是在与取栓联合时可产生协同作用。依达拉奉右莰醇注射用浓溶液（先必新®）是先声药业自主研发的多靶点脑细胞保护剂，该药物含依达拉奉和右莰醇两种活性成分，可高效透过血脑屏障，通过抗炎和清除自由基双效协同，减少大脑缺血-再灌注引发的级联损伤。 此前，王拥军教授团队主导的TASTE研究，以及北京大学第三医院樊东升教授牵头的TASTE-SL研究，分别以大样本随机对照的临床证据，证实了依达拉奉右莰醇的注射剂型，以及舌下片剂型对非取栓卒中患者的功能恢复作用。相关数据于2021年和2024年发表在国际神经病学顶级期刊STROKE（《卒中》）和JAMA Neurology（《美国医学会神经病学杂志 》）。依达拉奉右莰醇舌下片也于近日获美国FDA授予突破性疗法认定，用于缺血性脑卒中（AIS）治疗。 为探究脑细胞保护与取栓的结合是否能为取栓的卒中患者带来更多获益，王拥军教授团队又进一步推动了TASTE-2研究，证实了急性缺血性卒中患者在取栓前使用先必新®可进一步获益，以新的临床证据不断拓展着科学对“脑细胞保护”的认知。 本次世界卒中会发表的口头报告显示，TASTE-2研究入组的1362名接受取栓治疗的中-重度卒中患者，在取栓前使用依达拉奉右莰醇注射用浓溶液，对比安慰剂，90天后患者功能评分2以下的比例为55.0% vs 49.6%，差异具有统计学意义, 且安全性良好。这表明，卒中再灌注治疗前给予脑细胞保护，可进一步提升疗效，减少残疾的发生。 先声药业新闻稿表示，TASTE-2研究的最新结果，为脑细胞保护策略联合取栓术治疗急性缺血性脑卒中提供了关键性临床医学证据，有望为卒中患者的合理化治疗带来启示，以减少中国乃至全球因卒中致残人数。 参考资料： [1]先声药业新闻稿. 内容来源于网络，如有侵权，请联系删除。

NANJING, China, Oct. 25, 2024 /PRNewswire/ -- On October 24, 2024, TASTE-2, a Chinese innovative stroke drug study led by Professor Wang Yongjun from Beijing Tiantan Hospital, was published in an oral report at the 16th World Stroke Conference (WSC): brain cell protection combined with edaravone dexborneol (Sanbexin ®) in patients with acute ischemic stroke before endovascular thrombectomy significantly improved the proportion of patients who recovered neurological independence at 90 days and reduced the proportion of patients with disability. Continue Reading Professor Wang Yongjun from Beijing Tiantan Hospital gave oral lectures on behalf of the research team at the 16th WSC Conference on Late Breaking and SRTThrombectomy plus Sanbexin ® for further stroke reduction Stroke is the leading cause of death and disability in adults in China, and acute ischemic stroke (AIS) accounts for about 70% of all strokes. Among them, about 40% of patients belong to the risk subtype of large vessel occlusion (LVO), with higher disability and mortality. After stroke, treatment with "reperfusion", which is represented by thrombolysis and thrombectomy, restores blood supply to the brain as soon as possible. Endovascular thrombectomy (EVT) is an important advance in reperfusion therapy in recent years, which can achieve recanalization in about 70% to 90% of patients with LVO stroke, but only nearly half of patients recover well. A significant proportion of patients with EVT remain disabled to varying degrees after 90 days of treatment. The oral report on 2024WSC showed that a multicenter, double-blind, randomized, placebo-controlled TASTE-2 study enrolled 1362 patients with moderate-severe stroke treated with EVT. Edaravone dexborneol, a brain cell protection was used before EVT, and the proportion of patients with functional score 2 below 90 days was 55.0% vs. 49.6% compared with placebo, which was statistically significant and safe. This suggests that brain cell protection prior to stroke thrombectomy may further improve treatment outcomes in patients with large vessel occlusive stroke and help them regain self-care ability. TASTE-2 Primary Efficacy Results: There was a significant difference between the treatment and placebo groups in the proportion of patients who were functionally independent (90-day mRS 0 to 2), OR = 1.24 (1.00 to 1.54), p = 0.047; RR = 1.11 (1.00 to 1.23), p = 0.047 Sanbexin ® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-target brain cell protection developed by Simcere Pharmaceutical Co., Ltd. The drug contains two active ingredients, edaravone and dexborneol, which efficiently penetrate the blood-brain barrier, reduce cascade damage caused by AIS through dual effects of anti-inflammation and free radical scavenging, and extend the existing treatment window from 24 hours to 48 hours. As the only innovative drug approved for marketing and sales in the field of stroke treatment worldwide since 2015, this drug has been developed for 12 years. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexin ® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke and also trigger lively on-site discussion in international academia. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for a long time. However, for the complex pathophysiological mechanism of stroke, single-target drugs have limited efficacy and are difficult to develop clinically. Corresponding to this, multi-target brain cytoprotectants continue to progress in clinical practice. Previously, the TASTE study led by Professor Yongjun Wang 's team from Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan from Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients without thrombectomy, respectively. The data were published in STROKE (Stroke) and JAMA Neurology (American Medical Association Journal of Neurology), in 2021 and 2024. In the future, Sanbexin ® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy and administered before reperfusion to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED