Neuro

Remedy Pharmaceuticals Gets Rights To Acute Stroke Drug Back From Biogen; Announces Clinically Meaningful and Statistically Significant Results From Pre-specified Subgroup and Post Hoc Analyses of Phase 3 Study

NEW YORK, May 29, 2024 /PRNewswire/ — Remedy Pharmaceuticals, a pioneer in stroke drug development, announced that prespecified subgroup analyses from the Phase 3 CHARM clinical trial of CIRARA (IV glibenclamide) showed meaningful improvements in functional outcomes on the modified Rankin Scale (mRS), which were further validated in post hoc analyses.
The findings follow the early termination of the pivotal Phase 3 trial by Cambridge-based Biogen after a strategic realignment of resources, and the return of the program to Remedy.
The CHARM clinical trial was a multicenter, multinational, double-blind, randomized, placebo-controlled Phase 3 study involving patients aged 18-85 with a large hemispheric infarction (LHI), as indicated by an Alberta Stroke Program Early Computed Tomographic (CT) Score (ASPECTS) value of 1-5 (on a scale of 0-10) or an ischemic core volume of 80-300 ml by CT perfusion (CTP) or magnetic resonance imaging (MRI) diffusion weighted imaging. Patients were eligible if study drug was expected to start within 10 hours after they were last known well and were randomly assigned in a 1:1 ratio of CIRARA or placebo. A total of 535 patients were enrolled, including 431 patients aged 18-70 (the efficacy analysis population) and 81 patients aged 71-85.
Despite neutral top-line results, in pre-specified analyses, patients who received rtPA, underwent endovascular thrombectomy (EVT), were enrolled using CTP/MRI, had wake-up strokes, or were enrolled in the U.S., all had directionally improved functional outcomes in favor of CIRARA. A pre-specified analysis in patients with an NIH Stroke Scale (NIHSS) ≤20 (n=274) yielded statistically significant improvements in functional outcomes (Odds Ratio 1.66, p=0.03). With EVT therapy increasingly used in LHI, the Odds Ratio of 1.75 in the EVT subset, while not statistically significant, was particularly encouraging.
Building on these findings, post hoc analyses examining the impact of stroke severity on outcomes were performed and revealed significant findings:

In the mITT population with CTP/MRI lesion volume

Ceretrieve Announces Groundbreaking Success in FIH Ischemic Stroke Cases

Ceretrieve’s aspiration catheter demonstrated clots removal, completely restoring blood flow in a single pass.YOKNEAM, Israel, May 28, 2024 /PRNewswire/ — Ceretrieve announced today the successful results of the company’s multicenter, single-arm study, showcasing the capabilities of its state-of-the-art aspiration catheter. The study, conducted across two centers, included 20 patients who suffered from acute ischemic stroke (AIS) due to intracranial large vessel occlusion (LVO) and were eligible for thrombectomy within 24 hours of symptom onset. The study was aimed for assessing the safety and initial performance of the Ceretrieve Device.Redefining Stroke Treatment

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A brain clot removed with Ceretrieve’s device

Ceretrieve’s mission is to transform stroke care, save lives, minimize disability, and significantly improve post-stroke quality of life. Ceretrieve’s aspiration catheter is at the forefront of this mission, delivering aspiration capabilities that are far superior when compared to existing devices, allowing clot(s) removal in a single pass, while fully restoring blood flow. Designed for seamless integration within a conventional 6Fr delivery catheter, Ceretrieve’s device offers exceptional trackability and maneuverability, ensuring efficient access to the clot location.
As shown in the study conducted, Ceretrieve’s aspiration catheter not only excelled in performance but also ensured the highest safety standards by reducing the risk of releasing clot fragments further into the brain. In the first-in-human (FIH) study 80% Complete/Near-Complete Perfusion was achieved.The study included two generations of the device, and the results with the improved Gen 2 device are highly impressive: 100% Complete/Near-Complete Perfusion achieved in all treated patients; and 83% First Pass Complete Perfusion (FPE mTICI 3), far exceeding the 30%-40% rate of current gold-standard devices.Ceretrieve’s CEO, Maysa Mustafa: “The promising results of our clinical studies are the culmination of years of hard work and R&D. Our mission to redefine stroke treatment drives everything we do, and these results signify a major leap forward in saving and dramatically improving lives following an ischemic stroke.””The ‘first pass effect’ has been shown to improve patient outcomes” says Dr. Shady Jashan (Galilee Medical Center, Israel) who performed the first neuro thrombectomy procedure with the Ceretrieve device. “Our experience in FIH trials demonstrated that the Ceretrieve device quickly enables complete clot ingestion in first pass even for the most challenging clots and anatomies. This has the potential to dramatically improve patient clinical outcomes.”Prof. Serder Geyik, MD (Florya Medical Park, Turkey): “The term ‘Everything comes with a price’ is not valid for the Ceretrieve device. Ceretrieve’s device aspirates the clot with a giant bore tip- double than the largest catheters in the market, for maximal vacuum effect without paying the price in trackability. In addition, it provides local flow restriction in the middle cerebral artery reducing distal emboli. It is the only device that includes all the features for successful thrombectomy and first pass effect in one single device. “Amir Belson, M.D., Ceretrieve Chair: “With Ceretrieve’s advanced technology, we are seeing significant improvements in patient recovery rates. This innovation is setting a new standard in stroke care, offering patients better outcomes and real hope for recovery.”About Ceretrieve Ceretrieve’s vision is to be the doctor’s first-choice device in treating ischemic stroke offering complete treatment with superior performance in one device. Ceretrieve was established in 2017 in collaboration with The Trendlines Group (SGX:42T) (OTCQX: TRNLY), a leading investment group based in Israel and Singapore, as well as the Israel Innovation Authority (IIA) Incubators Program. Agriline and several angel investors are among the Company’s additional investors.Contact:Maysa Mustafa, CEO[email protected]Photo – https://mma.prnewswire.com/media/2423407/Ceretrieve_case.jpgSOURCE Ceretrieve

Results from BRAIN.Q’s EMAGINE Study on the Use of AI-Powered Electromagnetic Field Therapy Offer Hope for Meaningful Recovery Following Stroke

Promising results from the EMAGINE randomized trial suggest that treatment with BRAIN.Q’s AI-powered low electromagnetic field stimulation, aimed at enhancing the brain’s ability to relearn processes lost after a stroke, may help patients regain ‘freedom from disability’ with greater…

ACTICOR BIOTECH: Presentation of the Main Results of the Phase 2/3 ACTISAVE Study in the Treatment of Stroke at ESOC 2024

PARIS–(BUSINESS WIRE)–Regulatory News: “ACTISAVE Clinical Trial: Efficacy and Safety of Glenzocimab on Top of Thrombolysis with or without Mechanical Thrombectomy.” Post this ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, including stroke, announces the presentation, […]

Viz.ai and NICO Corporation Announce Collaboration to Improve Outcomes in Patients with Intracerebral Hemorrhage

SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with NICO Corporation (NICO), a leader in modern minimally-invasive interventional technologies for neurosurgery, to improve the lives of patients with intracerebral hemorrhages. “We’re excited to collaborate with NICO, leveraging our broadly deployed AI […]