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Demystifying blockchain oracles: Part 1

Simply put, blockchain oracles facilitate accessing, processing, and transmitting information between the outside world of off-chain data and smart contracts.

The post Demystifying blockchain oracles: Part 1 appeared first on CryptoSlate.

Bitcoin (BTC) Price Prediction: BTC/USD Remains Stable as Bitcoin Slumps above $42K

BTC Price Fluctuates Below $45K as Bitcoin Slumps above $42K – March 23, 2022 BTC/USD is still trading above the moving average as Bitcoin slumps [...]

Delayed: El Salvador’s Bitcoin Bond

March 23, 2022       /       Unchained Daily       /       Laura Shin Daily Bits ✍️✍️✍️ Bridgewater is preparing to back its first crypto fund. Mango DAO[...]

The post Delayed: El Salvador’s Bitcoin Bond appeared first on Unchained Podcast.

Has GameFi just found the perfect pairing as ex-Hearthstone designer joins FTX Gaming?

FTX US announced that they acquired Good Luck Games, the creators of the prominent auto-battle card game Storybook Brawl. Reviews of the game on Steam tanked on the news as gaming fans continue to show resistance to crypto entering the gaming ecosystem.

The post Has GameFi just found the perfect pairing as ex-Hearthstone designer joins FTX Gaming? appeared first on CryptoSlate.

Value Research Center (VRC) develops Value Model integrating ESG and Sustainability Measures

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KYOTO, Japan, Mar 24, 2022 - (JCN Newswire) - The Value Research Center (VRC) has launched an integrated Value Model with ESG and Sustainability measures in a new white paper issued today. With the shift from short term, profit-focused thinking towards long-term, sustainable, value-focused thinking, businesses globally need to answer a fundamental question: "What value are you providing our collective future?"

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A Value Model for Responsible Business: The new Value Research Center (VRC) white paper was officially released today. The VRC initiative is aimed at improving company performance and social impact.

The VRC at Doshisha University was established in November 2021 to create a Value Model that could guide any company to answer this question, so ensuring a more sustainable future. The VRC published its initial white paper, "Valuing Value", in June 2021, integrating 357 impact measurements from 15 of the world's top ESG and sustainability frameworks and developing a 7-stakeholder, 27-theme, 80-goal model to help businesses objectively and transparently measure and manage the value impacts that they have on their key stakeholders.

The VRC's new white paper entitled "A Value Model for Responsible Business", integrates an additional 346 impact measurements from 6 new frameworks into the initial model. These 6 frameworks include the International Sustainability Standards Board (ISSB) Prototype Climate-related disclosures; Task Force on Climate-related Financial Disclosure (TCFD) guidance on metrics, targets and transition plans; Stockholm Resilience Center's Planetary Boundaries; United Nations Development Program (UNDP) SDG Impact Standards for Enterprises; International Finance Corporation (IFC) Performance Standards; and Science Based Targets initiative (SBTi) climate disclosures.

The white paper is available for download: https://www.valueresearchcenter.com/2022whitepaper

Professor Philip Sugai, Director of the VRC, says "Our team analyzed hundreds of existing impact measurements and organized these into 27 common themes with 81 goals that any company, regardless of size, industry or location can use to measure, manage and use to consistently increase the value they create for stakeholders. Unlike existing ESG or sustainability reporting models, the VRC Value Model offers companies the ability to track their actual stakeholder impacts, using this data to create forward-looking strategies aimed at further increasing the value they create for and with these stakeholders."

Masato Yamazaki, Professor Emeritus of Economics at Aquinas College, Grand Rapids, Michigan, and VRC operating council member, said "The Value Model that our VRC research team offers is a more advanced approach than any other sustainability model or approach in existence today, since it can automatically help identify the root causes of the problems companies face via well-developed assessment tools."

"What is needed in sustainability efforts today goes beyond simple reporting," says Dr. Kumar Iyer, Mentor for Value Creation and VRC operating council member. "The VRC Value Model is based on objective metrics and quantifiable indicators which can be independently verified. This is uniquely different from any other sustainability reporting approach as it is directly linked to creating social impact.

About the Value Research Center (VRC)

The Value Research Center (VRC) was officially established at Doshisha University in Kyoto, Japan in 2021. The VRC is mandated to research and develop an open, accessible and transparent system for assessing and reporting on value creation (destruction) impacts that organizations of every size have over seven stakeholder groups: (1) the organization itself, (2) shareholders or owners, (3) customers, (4) employees, (5) partners, (6) the society within which it operates, and (7) the planet.

The VRC ensures that all relevant stakeholders which businesses impact are covered by assessment, and regularly updated based on scientific data. As part of the Doshisha University network, we bear the reputation of our parent and its stature as a global organization affiliated with world leading Universities that we call partners. Learn about VRC and its research at https://www.valueresearchcenter.com, or email Prof Philip Sugai at info@valueresearchcenter.com.

* Webinar, March 25 - IAFOR in discussion with VRC Director Philip Sugai
Dr. Joseph Haldane, Chairman & CEO of the International Academic Forum (IAFOR) will discuss the contents of this new white paper with VRC Director Prof. Philip Sugai in a Webinar on Friday, March 25, 5:00 - 6:00 pm JST, in collaboration with the new ESG-IREC Research Center at Osaka University. This webinar will be free to attend, and reservations can be made at: https://tinyurl.com/IRC-VRC-20220325

About the IAFOR Research Center (IRC)
The IRC aims to provide a research centre to nurture various international and interdisciplinary research policies that use the extensive networks of both Osaka University and IAFOR. https://iafor.org/.

About the ESG-IREC Research Center
The Osaka University Graduate School of International Public Policy - ESG Integration Research and Education Center (ESG-IREC) conducts research on practical implementable "ESG integration" models in corporate and business activities for the creation of a more sustainable future. https://www.osipp.osaka-u.ac.jp/en/.


Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comThe Value Research Center (VRC) launched an integrated Value Model with ESG and Sustainability measures in a new white paper issued today. With the shift from short term, profit-focused thinking towards long-term, sustainable, value-focused thinking, businesses globally need to answer a fundamental question: "What value are you providing our collective future?"

Bondly Gets Sued By G2 Esports Over Scrapped NFTS On Polygon

Bondly gets sued by G2 Esports over scrapped NFTs on Polygon and before its latest push, the NFTs never materialized so let’s find out more in today’s latest blockchain news. The Esports club G2 Esports filed a lawsuit against NFT provider Bondly and the company announced their partnership in 2021. Bondly gets sued because as […]
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Fusang delays security-token IPO amid market jitters

Tag Template - News Hub PRO PlatoBlockchain Data Intelligence | Vertical Search AI Conflict in Ukraine takes a toll on Malaysian exchange’s $10 million IPO just a week before planned listing.

Qantas announces NFT collection and becomes the second airline offering NFTs

Australian airline provider Qantas recently announced that they were planning an NFT drop to their frequent flyers.

The post Qantas announces NFT collection and becomes the second airline offering NFTs appeared first on CryptoSlate.

SEC Extends Window For WisdomTree BTC ETF Decision

SEC extends window for WisdomTree BTC ETF decision to May 15 and will also extend the window for One River’s decision to June 2 so let’s read more in today’s latest Bitcoin news. The US SEC extended its window to approve or to disapprove spot BTC exchange-traded fund applications from the asset managers One River […]

Algorand upgrades will boost speed and privacy, founder says

Tag Template - News Hub PRO PlatoBlockchain Data Intelligence | Vertical Search AI Algorand is planning a series of upgrades to bolster the network’s privacy and speed, and developing permissioned co-chains with a trustless decentralized bridge between chains, founder and MIT professor Silvio Micali said at Blockchain Week Australia on Tuesday.  See related article: What is Algorand and why is it a blockchain to watch? Fast facts Algorand […]

Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

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CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.

Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.

1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab

- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.

2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD

- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.

- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.

ARIA Incidence, Frequency, Severity and Modeling
ARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.

Study 201 Core ARIA-E Rates
ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.

Study 201 OLE ARIA-E Rates
Although ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).

Study 201 Core and OLE Pooled ARIA-E Rates
In the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.

ARIA-E Rates Frequency and Severity
In the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date.

Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4
The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.

ARIA-H Rates
In the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.

3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing

- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.

- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.

- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts.

4. Update on Lecanemab Clinical Development, Including New Subcutaneous Formulation
Eisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.

- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.

- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.

- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation (<15 second SC injection versus ~1h infusion). PK/PD modeling of Study 201 suggests that the average lecanemab concentration (Cave) predicts amyloid clearance while the maximal lecanemab concentration (Cmax) predicts ARIA-E rate. Since subcutaneous administration results in a blunted Cmax, the SC dose with comparable Cave to 10 mg/kg IV is hypothesized to have similar amyloid reduction with potentially reduced incidence of ARIA-E relative to IV but less than half the ARIA- E rate as IV. Eisai is evaluating the SC formulation in the Clarity AD OLE.

"The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease.

Contacts:

MEDIA CONTACT:
Eisai Co., Ltd.
Public Relations Department
+81-(0)3-3817-5120

Eisai Inc. (U.S.) Libby Holman
+ 1-201-753-1945
Libby_Holman@eisai.com

INVESTOR CONTACT:
Eisai Co., Ltd.
Investor Relations Department
+81-(0)70-8688-9685

MEDIA CONTACT:
Biogen Inc. Ashleigh Koss
+ 1-908-205-2572
public.affairs@biogen.com

INVESTOR CONTACT:
Biogen Inc. Mike Hencke
+ 1-781-464-2442
IR@biogen.com

For more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf.


Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.

New $100M Fund Aims To Bolster Blockchain Development in Vietnam

crypto funding

The crypto platform seeks to offer DeFi projects liquidity incentives and achieve regulatory compliance for crypto firms

The post New $100M Fund Aims To Bolster Blockchain Development in Vietnam appeared first on Blockworks.

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