Artificial Intelligence
Anavex Life Sciences Reports Data Review by the Independent Data Safety Monitoring Board for its Phase 2b/3 Clinical Trial of ANAVEX®2-73 in Patients with Alzheimer’s Disease
NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2b/3 study data.
As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.
Upon review of the interim safety data, the DSMB made the following recommendation:
- The DSMB recommendation is to continue the studies without modification.
DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.1
PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.2
The ongoing placebo-controlled 450-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer’s disease is presently over 92% enrolled and includes prespecified SIGMAR1 gene expression as endpoints using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.3
Anavex Life Sciences’ product portfolio includes small drug molecule lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
About ANAVEX®2-73-AD-004 Clinical Study (ClinicalTrials.gov Identifier: NCT03790709) and OLE ANAVEX®2-73-AD-EP-004 Clinical Study ATTENTION-AD (ClinicalTrials.gov Identifier: NCT04314934)
ANAVEX®2-73-AD-004 clinical study is a Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study is expected to enroll approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the previous ANAVEX®2-73 Phase 2a study (ANAVEX2-73-002, NCT02244541). Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).4 ANAVEX®2-73-AD-EP-004 is the 96-week open label extension of the placebo-controlled Phase 2b/3 ANAVEX®2-73 study.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. An estimated 5.7 million Americans have currently Alzheimer’s dementia. Alzheimer’s is the most common cause of dementia among older adults and is estimated to rank as the third leading cause of death for older people in the United States, just behind heart disease and cancer. In 2020, Alzheimer’s and other dementias cost the nation $305 billion. By 2050, these costs could rise as high as $1.1 trillion.5 There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050.6 Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3 seconds, and a significant increase in the caregiving burden placed on society and families.7
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed successfully a Phase 2a clinical trials for Alzheimer’s disease and a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]
_____________________________________
1 Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
2 https://assets.researchsquare.com/files/rs-189177/v1/65385792-095a-4505-90c4-c0b85c76dbd1.pdf.
3 ClinicalTrials.gov Identifier: NCT03790709.
4 Hampel H. et al. (2020). A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the blarcamesine (ANAVEX2‐73) Phase 2a clinical study. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 6(1), e12013.
5 https://www.nia.nih.gov/health/alzheimers; https://www.alz.org/alzheimers-dementia/facts-figures.
6 Alzheimer’s Disease International. World Alzheimer Report 2019. https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf.
7 AARP. 2020 Report: Caregiving in the U.S. https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf.
Artificial Intelligence
Clinical Trials Matching Software Market Projected to Reach $832.56 million by 2030 – Exclusive Report by 360iResearch
PUNE, India, April 18, 2024 /PRNewswire/ — The report titled “Clinical Trials Matching Software Market by Functionality (Analytics & Reporting, Compliance Tracking, Data Management), Deployment (Cloud & Web Based, On-Premise), End-Use – Global Forecast 2024-2030” is now available on 360iResearch.com’s offering, presents an analysis indicating that the market projected to grow from a size of $342.20 million in 2023 to reach $832.56 million by 2030, at a CAGR of 13.54% over the forecast period.
“The Global Surge in Adoption of Matching Software for Enhanced Participant Enrollment”
Clinical trials matching software stands at the forefront of revolutionizing clinical research by automating the process of identifying and enrolling eligible participants. These platforms offer a streamlined approach to match patient health profiles with trial requirements, accelerating enrollment and supporting the shift toward personalized healthcare using these advanced AI and ML technologies. Although integrating these systems poses challenges due to variations in healthcare IT infrastructure and the imperative for rigorous data security, the potential for market growth is substantial. In the Americas, a robust clinical trials ecosystem thrives; in the European Union, it has unified regulatory standards and extended to emerging regions such as the Middle East, Africa, and the APAC countries; the demand for such innovative solutions is on a steep rise. This demand is fueled by governmental support, the evolving regulatory landscape, and strategic partnerships to embed these solutions within electronic health records, underscoring a global movement toward optimizing clinical trial processes to better cater to specific patient demographics.
Download Sample Report @ https://www.360iresearch.com/library/intelligence/clinical-trials-matching-software
“The Rise of Virtual Trials and Advanced Matching Software”
The healthcare landscape is witnessing a transformative shift toward virtual clinical trials, fueled by technological advancements and the necessity for continuity during the COVID-19 pandemic. This transition supports research amid social distancing measures and introduces significant cost savings by reducing the need for physical infrastructure and in-person interactions. The efficiencies brought by electronic health records (EHR), wearable technologies, and automation streamline the entire process, from patient recruitment to data analysis. Several approaches, endorsed by regulatory bodies such as the FDA, represent a leap forward in making clinical trials more accessible and streamlined, ensuring that more patients can participate in potentially life-saving research without the geographical and logistic constraints of traditional trials.
“Enhancing Clinical Trials through Advanced Analytics, Rigorous Compliance, and Precision-Patient Matching”
Integrating advanced analytics, meticulous compliance monitoring, and precision-patient matching marks a significant advancement toward maximizing efficiency and fostering trial diversity. The software delivers insightful data on trial progress, participant demographics, and enrollment figures, empowering stakeholders to make well-informed decisions and optimize resource distribution to meet trial goals effectively by implementing cutting-edge analytics. The built-in compliance feature ensures trials are conducted in strict adherence to regulatory standards, minimizing risks associated with non-compliance. Furthermore, a robust data management system guarantees the integrity and availability of clinical trial data, which is critical for the seamless operation and real-time analysis of trials. The software includes state-of-the-art patient matching technology, which employs sophisticated algorithms and artificial intelligence to expedite recruitment by accurately identifying candidates who match specific trial requirements. This innovative approach accelerates the recruitment timeline and enhances the diversification of trial participants, paving the way for more inclusive and representative clinical research outcomes.
Request Analyst Support @ https://www.360iresearch.com/library/intelligence/clinical-trials-matching-software
“Medidata by Dassault Systèmes SE at the Forefront of Clinical Trials Matching Software Market with a Strong 11.30% Market Share”
The key players in the Clinical Trials Matching Software Market include International Business Machines Corporation, Science 37, Inc. by eMed, LLC, Medidata by Dassault Systèmes SE, AutoCruitment LLC, Deep 6 AI Inc., and others. These prominent players focus on strategies such as expansions, acquisitions, joint ventures, and developing new products to strengthen their market positions.
“Introducing ThinkMi: Revolutionizing Market Intelligence with AI-Powered Insights for the Clinical Trials Matching Software Market”
We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Clinical Trials Matching Software Market. ThinkMi stands out as your premier market intelligence partner, delivering unparalleled insights with the power of artificial intelligence. Whether deciphering market trends or offering actionable intelligence, ThinkMi is engineered to provide precise, relevant answers to your most critical business questions. This revolutionary tool is more than just an information source; it’s a strategic asset that empowers your decision-making with up-to-the-minute data, ensuring you stay ahead in the fiercely competitive Clinical Trials Matching Software Market. Embrace the future of market analysis with ThinkMi, where informed decisions lead to remarkable growth.
Ask Question to ThinkMi @ https://app.360iresearch.com/library/intelligence/clinical-trials-matching-software
“Dive into the Clinical Trials Matching Software Market Landscape: Explore 190 Pages of Insights, 286 Tables, and 22 Figures”
PrefaceResearch MethodologyExecutive SummaryMarket OverviewMarket InsightsClinical Trials Matching Software Market, by FunctionalityClinical Trials Matching Software Market, by DeploymentClinical Trials Matching Software Market, by End-UseAmericas Clinical Trials Matching Software MarketAsia-Pacific Clinical Trials Matching Software MarketEurope, Middle East & Africa Clinical Trials Matching Software MarketCompetitive LandscapeCompetitive PortfolioInquire Before Buying @ https://www.360iresearch.com/library/intelligence/clinical-trials-matching-software
Related Reports:
Clinical Trial Support Services Market – Global Forecast 2024-2030Virtual Clinical Trials Market – Global Forecast 2024-2030Clinical Trials Management System Market – Global Forecast 2024-2030About 360iResearch
Founded in 2017, 360iResearch is a market research and business consulting company headquartered in India, with clients and focus markets spanning the globe.
We are a dynamic, nimble company that believes in carving ambitious, purposeful goals and achieving them with the backing of our greatest asset — our people.
Quick on our feet, we have our ear to the ground when it comes to market intelligence and volatility. Our market intelligence is diligent, real-time and tailored to your needs, and arms you with all the insight that empowers strategic decision-making.
Our clientele encompasses about 80% of the Fortune Global 500, and leading consulting and research companies and academic institutions that rely on our expertise in compiling data in niche markets. Our meta-insights are intelligent, impactful and infinite, and translate into actionable data that support your quest for enhanced profitability, tapping into niche markets, and exploring new revenue opportunities.
Contact 360iResearchMr. Ketan Rohom360iResearch Private Limited,Office No. 519, Nyati Empress,Opposite Phoenix Market City,Vimannagar, Pune, Maharashtra,India – 411014.Email: [email protected]: +1-530-264-8485India: +91-922-607-7550
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BOSTON, April 18, 2024 /PRNewswire/ — The RepTrak™ Company, the world’s leading reputation data and insights company, released its annual Global RepTrak 100 report. Utilizing its advanced reputation monitoring software, RepTrak gathered data from more than 243,000 survey responses across 14 major economies to rank the world’s 100 most reputable companies. They share that ranking alongside a full analysis of global corporate reputation trends and corresponding public sentiment in the 2024 report.
After two years of consecutive Reputation Score declines, this year’s Score is back up with an increase from 73.2 in 2023 to 73.8 in 2024. It’s a small increase after 2023’s full one-point drop. However, it’s an encouraging sign that companies have begun to recover from reputation falls driven by many challenges: macroeconomic issues, workplace difficulties, product problems, and corporate responsibility skepticism.
“This year’s report underscores a pivotal shift in the corporate landscape, spotlighting the remarkable adaptability and dedication of the Top 100 companies in responding to the dynamic needs of stakeholders,” states RepTrak CEO Mark Sonders. “The companies featured in our report are not just riding the wave of change; they are the ones steering it, proving that the best approach to business is one that embraces evolution and champions progress.”
RepTrak’s report explores how people thought, felt, and acted toward companies over the past year. Findings include notable increases in Conduct and Citizenship efforts, stakeholders’ rising willingness to invest, culturally resonant brand communications, and ESG Scores that soared despite skepticism around the acronym.
To read the full 2024 Global RepTrak 100 report, please visit: www.reptrak.com/globalreptrak
About RepTrak
The RepTrak™ Company is the world’s leading reputation data and insights company. We help companies by organizing and grading a variety of reputational elements, offering a real-world report card on their corporate reputation. Subscribers to the RepTrak program use our predictive insights to protect business value, improve return on investment, and increase their positive impact on society. RepTrak’s pairing of advanced metrics and dedicated reputation advisors offers clients an actionable analysis of their reputation data, aligning business objectives with stakeholder sentiment across different markets and sectors.
Established in 2004, The RepTrak Company owns the world’s largest reputation benchmarking database, gathering over 1 million company ratings per year used by CEOs, boards, and executives in more than 60 countries worldwide. For more information, please visit: www.reptrak.com
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Artificial Intelligence
Group-IB takes part in a global operation to cripple Canadian Phishing-as-a-Service provider LabHost
SINGAPORE, April 18, 2024 /PRNewswire/ — Group-IB, a leading cybersecurity company aimed at investigating, preventing, and fight digital crime announced today that it participated in a coordinated global takedown operation against prominent Canadian Phishing-as-a-Service (PhaaS) provider LabHost, which has led to the arrest of 37 suspects across the United Kingdom and around the world by law enforcement agencies. As part of the operation, Group-IB also conducted an extensive analysis of LabHost’s criminal history and infrastructure, including insights into LabHost’s administrative platform and the services it provides to its purported user base which exceeds 2,000 subscribers worldwide, who illegally obtained around 480,000 card numbers, 64,000 pin numbers, and over 1 million passwords from victims used for websites and other online services, according to law enforcement agencies.
“By leveraging our Threat Intelligence and Digital Risk Protection, we are able to identify and monitor phishing attacks and websites like those deployed by LabHost and its subscribers around the world, enabling us to actively alert and protect our customers, and in turn, their customers as well,” said Dmitry Volkov, Chief Executive Officer of Group-IB. “Today’s takedown operation demonstrates the agility and responsiveness of our decentralized Digital Crime Resistance Centers, and how quickly we can provide immediate and local assistance wherever our customers may be.”
First uncovered in late 2021, LabHost emerged as a fully automated Phishing-as-a-Service (PhaaS) platform, streamlining the creation of phishing websites meticulously mirroring the interface and functionality of prominent banking, postal, and financial entities, aimed at intercepting, seizing, and profiting from users’ personal, credit card, and online banking credentials. Users are prompted to select from various “membership plans,” tailored to target businesses and individuals in either the United States and Canada, or globally, akin to mobile subscription models. These plans encompass “standard,” “premium,” and “world membership” tiers, priced between US$179 and US$300 monthly, with options for monthly, quarterly, or annual billing cycles.
For media inquiries, please contact [email protected]
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