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Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Significantly Prevented Aβ (Abeta)-induced Cognitive Deficits with Confirmed Significant Biomarker-response in Animal Model of Alzheimer’s Disease

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3 years ago

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Pre-Treatment with ANAVEX®2-73 entirely prevented Abeta-induced cognitive decline

Anavex planning a Phase 3 prevention trial of ANAVEX®2-73 including participants at risk for cognitive and functional decline related to Alzheimer’s disease

NEW YORK, July 29, 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) disorders, today reported new data that established ANAVEX®2-73 to be a preventive treatment in the pharmacological model of Alzheimer’s disease (AD). Pre-treatment with ANAVEX®2-73, repeated once daily for one week before the Aβ (Abeta) challenge was protective in the Aβ25-35 peptide model of Alzheimer’s disease in mice. ANAVEX®2-73 significantly and dose-dependently prevented Aβ25-35-induced biomarker-correlated cognitive impairments, which were assessed one week after the Aβ (Abeta) insult during which no further ANAVEX®2-73 treatment took place.

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 SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aβ production2.

“We are excited about this data, which indicates the potential expansion for the ANAVEX®2-73 platform to find an effective Alzheimer’s prevention therapy, which might benefit the entire field,” said Christopher U. Missling, PhD, President & Chief Executive Officer of Anavex. “In addition to finding treatment options for Alzheimer’s disease, we are also striving to find effective prevention therapies for this devastating disease, and this data might help advance this endeavor to address an area of high unmet medical need.”

Data from this study will be submitted later this year for presentation at a scientific medical meeting.

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Previously, a publication in Neuropharmacology noted that in a clinical study (ANAVEX2-73-002) of Alzheimer’s disease patients, 57 weeks of oral once daily ANAVEX®2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.3

An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.4,5

This data seems to be consistent with the effect of ANAVEX®2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson’s disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).6 CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).7 The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).

The Company recently announced that it has exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine) double-blind, placebo-controlled late-stage Phase 2b/3 study (ANAVEX2-73-004) in Alzheimer’s disease.

Anavex Life Sciences’ product portfolio platform includes orally available small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome and ANAVEX®3-71 for frontotemporal dementia.

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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 currently have 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 approximately $305 billion. By 2050, these costs could rise as high as $1.1 trillion.8 There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050.9 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.10

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), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently 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, Instagram and LinkedIn.

Forward-Looking Statements

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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 Jaeger PA, Pickford F, Sun C-H, et al. Regulation of amyloid precursor protein processing by the Beclin 1 complex. PloS one. 2010;5(6):e11102.
3 Hampel H, Vergallo A, Caraci F, Cuello AC, Lemercier P, Vellas B, Giudici KV, Baldacci F, Hänisch B, Haberkamp M, Broich K, Nisticò R, Emanuele E, Llavero F, Zugaza JL, Lucía A, Giacobini E, Lista S; Alzheimer Precision Medicine Initiative. Future avenues for Alzheimer’s disease detection and therapy: liquid biopsy, intracellular signaling modulation, systems pharmacology drug discovery. Neuropharmacology. 2021 Mar 1;185:108081. doi: 10.1016/j.neuropharm.2020.108081. Epub 2020 May 11. PMID: 32407924.
4 Hampel H. et al., 2018. Full genomic analysis of ANAVEX®2-73 phase 2a Alzheimer’s disease study identifies biomarkers enabling targeted therapy and a precision medicine approach. Alzheimer’s & Dementia 14, P1519–P1520. https://doi.org/10.1016/j.jalz.2018.07.027.
5 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.
6 https://www.anavex.com/proof-of-concept-controlled-phase-2-clinical-trial-data-evaluating-anavex2-73-blarcamesine-in-parkinsons-disease-dementia-presented-at-ctad-2020-conference/.
7 Wesnes K. et al., Computerized cognition assessment during acetylcholinesterase inhibitor treatment in Alzheimer’s disease. Acta Neurol Scand 2010; 122:270–7.
8 https://www.nia.nih.gov/health/alzheimers; https://www.alz.org/alzheimers-dementia/facts-figures.
9 Alzheimer’s Disease International. World Alzheimer Report 2019. https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf.
10 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.

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Akuvox S567G Smart Indoor Monitor Has Received Google Mobile Service Certification

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11 hours ago

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September 14, 2024

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XIAMEN, China, Sept. 13, 2024 /PRNewswire/ — Akuvox has announced its S567G, an indoor monitor powered by Android™, to have received Google GMS certification. This certification ensures full support for Google Services, allowing users to download and update apps directly from the Google Play Store, including smart home control apps. It also enhances system security, protecting against malware and unauthorized access.

GMS certification involves comprehensive testing and approval by Google or a designated 3PL lab, validating security and compatibility to ensure seamless integration within the Android ecosystem. Receiving GMS certification underscores Akuvox’s leadership in the smart intercom industry. Building on its legacy as the pioneer of Android smart intercoms, Akuvox continues to elevate its Android systems with Google’s rigorous certification, offering clients flexible and sophisticated smart intercom solutions. 
The S567G’s GMS certification ensures flawless operation with key Google apps like Chrome, Gmail, YouTube, Maps, and the Play Store. Edward Shi, Product Manager of the S567G, notes, “The positive feedback we’ve received from clients, even during testing, confirms that this device is transforming daily life. It’s more than just an intercom — it’s a versatile tool, even capable of functioning as a small TV. Our team has worked tirelessly to meet the highest standards, and I’m excited to see how it enhances smart living for our users.”
The S567G’s features extend beyond intercom functionality. With four HD speakers and a 1280 x 800 IPS LCD screen, it offers an exceptional audio-visual experience, redefining the concept of an indoor monitor. Whether for entertainment or smart home control, the S567G stands out as a versatile wall-mounted tablet, bringing innovation to every interaction.
About Akuvox
Akuvox is a global leading provider of smart intercom and smart home products and solutions. It is committed to unleashing the power of technology to improve people’s lives with better communication, greater security, and more convenience. Encompassing artificial intelligence, SIP, Android, cloud, security, and other advanced technologies, Akuvox continuously drives breakthrough changes in the industry and creatively delivers an unrivaled portfolio of smart intercom and smart home products and solutions. It has been deployed and used daily in more than 110 countries and regions, meeting customer needs in various vertical markets that range from residential to commercial, from healthcare to public safety.
Photo – https://mma.prnewswire.com/media/2504901/Akuvox_S567G_Indoor_Monitor_Has_Received_GMS_CertificationAkuvox_proudly_announced.jpg 

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SeaBubbles Accelerates Sustainable Maritime Mobility with SmartBubble and Strategic Acquisition

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21 hours ago

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September 13, 2024

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SAINT JORIOZ, France, Sept. 13, 2024 /PRNewswire/ — SeaBubbles, French pioneer in zero-emission hydrofoils, strengthens its commitment to ecological transition with the launch of SmartBubble, new flying boat model combining cutting-edge technology with iconic design. This innovative vessel, designed to carry up to eight people at a speed of 16 knots (30 km/h), takes its passengers on a silent and environmentally friendly flight, ideal for water taxi services and urban transportation.

SmartBubble: Concentration of Technology and Design
Following the success of its first public line on Lake Annecy, where hundreds of passengers experienced the unique sensation of flying aboard The Bubble (4-seater model), SeaBubbles reaches a new milestone with the homologation of the SmartBubble (8-seater model) and its four patents, including retractable foils.
SmartBubble technology is geared towards energy efficiency. The submerged wings (foils) equipped with automatic flaps allow to fly at low speeds, saving 40% of energy required. This unique boat has just been presented afloat for the first time at the Cannes Yachting Festival.
SeaBubbles Strengthens Flight Control Expertise with Neocean Acquisition
SeaBubbles also announces the acquisition of Neocean technology, to accelerate the development of flight control expertise, specifically on “inverted T” foils. Neocean is renowned for developing the Overboat, foiling catamaran with proven stability and maneuverability.
SeaBubbles is a key player in hydrofoil navigation, technology that improves energy efficiency of boats, particularly electric ones. The flight control system is a central element of the flight experience: it is designed to ensure stable flight by dynamically and autonomously managing the mechanical inclination of the flaps on the trailing edges of the foils.
SeaBubbles: Vision for the Future
SeaBubbles’ ambition is to revolutionize urban and suburban maritime transport with more efficient and environmentally friendly boats. Examples such as the Calanques National Park, Norwegian fjords, alpine lakes or the canals of Amsterdam demonstrate a committed initiative towards the preservation of aquatic ecosystems by gradually banning the circulation of thermal boats.
“Foils significantly reduce the drag of our boats, allowing our hydrofoils to move more easily and with less energy than a conventional boat: a considerable gain in cost and energy,” explains Virginie Seurat, CEO of SeaBubbles. “The acquisition of Neocean marks a decisive turning point and prepares us for our industrialization phase. We are ready to redefine the pleasure of boating and offer boats that comply with increasingly stringent environmental standards, while offering unique sailing comfort – zero noise, zero waves, zero emissions.”
AxiCom for SeaBubbles, [email protected] 
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Amagi and BuyDRM Partner to Secure Streaming Video on PlayMedia’s FAST Platform GoPlay

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21 hours ago

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September 13, 2024

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NEW YORK, Sept. 13, 2024 /PRNewswire/ — Amagi, the global leader in cloud-based SaaS technology for broadcast and connected TV (CTV), today announced a partnership with BuyDRM, a leading content security services and solutions provider offering cloud-based content security for the streaming video platform GoPlay by PlayMedia. This successful collaboration with BuyDRM’s KeyOS Content Security Platform provides robust safeguards for valuable video content while allowing PlayMedia to focus on delivering high-quality video experiences to its audience without compromising security.

This partnership marks a significant step forward in addressing the evolving challenges of content security in today’s digital landscape. By combining BuyDRM’s expertise in DRM solutions with Amagi’s scalable cloud infrastructure, PlayMedia can ensure comprehensive protection for its content library against piracy and unauthorized access.
BuyDRM’s KeyOS Content Security Platform is an award-winning, studio-approved multi-DRM and watermarking content security platform for video. The KeyOS platform protects the assets of copyright holders and distributors with robust security services and solutions for high-value video content and is trusted by many of the most prominent names in media and entertainment across the globe.
Srinivasan KA, Co-Founder and Chief Revenue Officer at Amagi, said, “Our partnership with BuyDRM aligns perfectly with our endeavor to empower content creators and distributors with innovative technology. Integrating BuyDRM’s KeyOS platform into our cloud-based platform offers our customers like PlayMedia the peace of mind they need to focus on delivering exceptional content.”
“The alliance with Amagi made it possible for our mutual customer, PlayMedia, to utilize our content security offering in a cloud-based environment without sacrificing their security standards and the user experience,” said Christopher Levy, BuyDRM CEO and Co-Founder. “Both companies worked hard to empower PlayMedia with the technology needed to thrive in today’s streaming market.”
Amagi provides a complete suite of channel creation, distribution, and monetization solutions. The company’s clients include some of the world’s biggest names, including A+E Networks UK, ABS-CBN, Astro, Cox Media Group, DAZN, Globo, Lionsgate Studio, NBCUniversal, Tastemade, and VIZIO.
Amagi is exhibiting at IBC2024. Attendees can join Amagi and experience its innovative media cloud platform, which addresses unified broadcast and streaming TV workflows. Click here to book a meeting with Amagi executives.
About Amagi
Amagi is a next-generation media technology company that provides cloud broadcast and targeted advertising solutions to broadcast TV and streaming TV platforms. Amagi enables content owners to launch, distribute, and monetize live, linear channels on Free Ad-supported Streaming TV and video services platforms. Amagi also offers 24×7 cloud-managed services, bringing simplicity, advanced automation, and transparency to all broadcast operations. Overall, Amagi supports 800+ content brands, 800+ playout chains, and 5,000+ channel deliveries on its platform in over 150 countries. Amagi has a presence in New York, Los Angeles, Toronto, Mexico City, London, Paris, Sydney, Seoul, and Singapore, broadcast operations in New Delhi, and innovation centers in Bengaluru, Zagreb, and Łódź.
About BuyDRM
BuyDRM™ is a leading global provider of content security services for the entertainment, education, enterprise, and hospitality industries. BuyDRM’s KeyOS content security platform powers many of the largest brands in media and technology. With decades of market-leading experience implementing commercial content security solutions and media technologies, BuyDRM has amassed substantial success stories for many of today’s largest brands such as ABC (Australian Broadcasting Corporation), Daily Rounds, Deluxe Digital, EPIX, FuboTV, POPS Singapore, Rakuten Viki, Redbox, Roku, Samsung TV+, SBS Australia, Showtime, Sinclair Digital, Soundcloud, Sportradar, TubiTV and ViaPlay.
For more information, please visit www.buydrm.com.
Amagi Contact:
Aashish WashikarDirector – Corporate Communications Email: [email protected]
Photo: https://mma.prnewswire.com/media/2505092/Amagi_BuyDRM.jpg
 

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