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

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

NORFOLK, Va.--( BUSINESS WIRE )--ReAlta Life Sciences, Inc. ("ReAlta" or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced that the first patient has been dosed in its Phase 2 study of RLS-0071, the Company’s lead therapeutic candidate, for the treatment of hospitalized patients with moderate to very severe steroid-refractory acute graft-versus-host disease (aGvHD), a serious and often fatal complication following hematopoietic stem cell transplantation. “Hematopoietic stem cell transplantation is one of the most impactful treatments available for people with cancer, autoimmune disease, sickle cell disease and other life-threatening disorders. However, the procedure can quickly turn into a severe and life-threatening condition for those who are affected by acute graft-versus-host disease in which the transplanted immune cells attack the patient, leading to severe inflammation and tissue damage,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “We believe that RLS-0071 has the potential to be a powerful new tool to improve outcomes for individuals with this serious complication of transplantation. We aim to leverage RLS-0071's unique dual mechanism-of-action (MOA) to inhibit unwanted inflammatory side-effects from the donor cells. We are committed to advancing this clinical program on behalf of patients facing steroid-refractory aGvHD.” Patients with aGvHD who do not respond to standard steroid treatments have limited therapeutic options and face severe inflammation, tissue damage and a high risk of mortality. Each year, approximately 4,000 patients develop steroid-refractory aGvHD within the U.S., EU and Japan. RLS-0071, an investigational medicine based on the Company’s novel EPICC peptide platform, seeks to address this unmet medical need by capitalizing on its unique dual-targeting MOA to modulate both the complement and innate inflammatory pathways, offering a new hope for patients with this devastating condition. RLS-0071 was recently granted Orphan Drug Designation and Fast Track Designation for the treatment of steroid-refractory aGvHD by the U.S. Food and Drug Administration (FDA). The Company is also currently conducting Phase 2 clinical trials of RLS-0071 in newborns with hypoxic ischemic encephalopathy (HIE) ( NCT05778188 ) and hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) ( NCT06175065 ). About the Study The Phase 2 study ( NCT06343792 ) is an open-label, prospective, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing and efficacy of RLS-0071 for the secondary treatment of acute graft-versus-host disease (aGvHD) in hospitalized patients who are steroid-refractory. Participants will receive RLS-0071 at their assigned dose level(s) for 7 or 14 days as either a monotherapy or concurrent with the standard-of-care treatment, ruxolitinib. Primary outcomes measures include safety and overall response rate. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address life threatening rare and acute inflammatory diseases. The Company’s EPICC peptide platform is based on discoveries related to the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system – a trait unique among viruses. By inhibiting activation of the complement cascade and two key neutrophil-driven mechanisms of inflammation and host tissue destruction - myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), ReAlta’s therapeutic peptides leverage the dual-targeting mechanisms of this human enteric virus – and its millions of years of evolutionary adaptations – to modulate both complement and innate inflammatory pathways. The Company’s pipeline is led by RLS-0071, which has received both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage in oxygen-deprived newborns and is a leading cause of cerebral palsy; Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of acute graft-versus-host disease (aGvHD), a disease associated with bone marrow and stem cell transplants whereby transplanted white blood cells attack the new host in an inflammatory response; and IND clearance by the FDA for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), an inflammatory lung disease characterized by progressive airflow limitations and tissue destruction that makes it challenging for patients to breathe. The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com .