Tag: predict
Eisai: Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM
Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen's ongoing commitment to increase diversity in clinical trials.
"Historically, patients from diverse backgrounds have been poorly represented in Alzheimer's disease clinical trials, and we are committed to changing this," said Priya Singhal M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. "This goal matches the diversity among Americans diagnosed with early Alzheimer's disease, while at the same time, the trial will generate substantial data to verify the effectiveness of ADUHELM."
Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer's disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens.
"It's important to see this ambitious focus on diversity being prioritized in enrollment and integrated as a key part of the ENVISION clinical trial, so that we can have data from patients who more closely represent what we see in the clinic," said Dylan Wint, M.D., Cleveland Clinic Lou Ruvo Center for Brain Health, Nevada.
The companies also announced today that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months after treatment initiation with ADUHELM. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer's disease, is consistent with ADUHELM's Phase 3 EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer's disease (Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease), with confirmation of amyloid beta pathology, to further strengthen the data provided by the study.
Although ENVISION and other ADUHELM clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services (CMS) recently released a draft National Coverage Determination (NCD), which would restrict Medicare coverage of ADUHELM and other amyloid-targeting therapies to patients enrolled in additional clinical trials. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer's disease since 2003.
In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).
The initiation of patient screening for ENVISION is planned for May 2022. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The companies are grateful to the healthcare professionals, medical centers, patients and families who will participate in this trial.
Previously, in July 2021(New Window), the companies set another substantial diversity goal in the observational Phase 4 ICARE AD trial, which aims to enroll a total of approximately 6,000 patients.
About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use
ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or "ARIA". ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient's healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
MEDIA CONTACTS
Biogen Inc.
Ashleigh Koss
+ 1-908-205-2572
[email protected]
Eisai Inc. (U.S. Media)
Public Relations Department
+1-201-753-1945
Eisai Co., Ltd. (Media Outside the U.S.)
Public Relations Department
TEL: +81-(0)3-3817-5120
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; results from ENVISION; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; clinical development programs, clinical trials and data readouts and presentations; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comBiogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer's disease, including details of the study's goal for diverse enrollment and primary endpoint.
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NextPlay Technologies Longroot Selected by Ample Health to Lead Security Token Offering
Ample Health is an emerging cannabis company operating from seed to sale in Southeast Asia. The company is looking to use the proceeds from its STO to fund its development and global expansion.
Longroot will be responsible for structuring the offering and raising the initial capital to fund the STO. This will involve developing the registration statements for all relevant jurisdictions, including preliminary and final prospectuses. It intends to lead Ample through the entire regulatory approval process, and then assist in the pricing and launching the STO through the Longroot portal.
"This Ample Health STO represents a tremendous opportunity for us to represent a major client in the fast-growing global cannabis space," commented Todd Bonner, director of Longroot (Thailand) Limited and chairman of NextPlay Technologies. "Once complete, we believe it will represent the first of many successful STOs for Longroot that we are currently advancing in our pipeline."
Ample Health looks to take advantage of the global cannabis market which is projected to grow at a 32% compounded annual growth rate from $28.3 billion in 2021 to $197.74 billion by 2028, according to Fortune Business Insights.
Akira Wongwan, CEO and co-founder of Ample Health, commented: "We selected Longroot to lead our STO due to its experienced management and well-established presence in the digital offering marketplace, as well as its Thai federal government licensing and oversight. Together, we believe this will ensure a highly-successful STO and the launch of our global cannabis platform."
The proposed offering targets to raise between USD $100-250 million. Longroot will receive a management and placement fee on the proceeds raised due immediately upon closing of the offering, which is expected to occur by the summer of 2022.
Disclaimer
The information included in the press release is for informational purposes only. It is not intended to be, nor should it be construed as, an offer or solicitation for the purchase or sale of any financial instrument, security or digital currency, or as an official confirmation of any transaction. All market information, data and other information included herein are not guaranteed as to completeness or accuracy and are subject to change without notice.
This press release is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from Ample Health and will contain detailed information about the company and management, as well as financial statements.
About Ample Health
Ample Health is an emerging cannabis company operating from seed to sale in Southeast Asia. It is focused on bringing synergy between growers, extractors, retailers and regulators, to help them compete in the domestic and international cannabis market and creating a fair and sustainable industry for all.
About Longroot
Authorized and regulated under global-leading Thai federal digital asset business law and licensed by the Securities & Exchange Commission of Thailand, Longroot (Thailand) Limited provides fully regulated and licensed digital asset financing and investment services for digital assets. Longroot is focused on creating regulated cryptocurrencies used in wholesale travel, real estate and hotels, gaming assets, insurance and digital advertising. As a Thailand-based corporation, Longroot is indirectly controlled by NextPlay Technologies. For more information, go to longroot.co.th.
About NextPlay Technologies
NextPlay Technologies, Inc. (Nasdaq: NXTP) is a technology solutions company offering games, in-game advertising, crypto-banking, connected TV and travel booking services to consumers and corporations within a growing worldwide digital ecosystem. NextPlay's engaging products and services utilize innovative AdTech, Artificial Intelligence and Fintech solutions to leverage the strengths and channels of its existing and acquired technologies. For more information about NextPlay Technologies, visit www.nextplaytechnologies.com and follow us on Twitter @NextPlayTech and LinkedIn.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of, and within the safe harbor provided by the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements give our current expectations, opinions, belief or forecasts of future events and performance. A statement identified by the use of forward-looking words including "will," "may," "expects," "intends," "projects," "anticipates," "plans," "believes," "estimate," "should," and certain of the other foregoing statements may be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release. Factors that may cause such a difference include risks and uncertainties including, and not limited to, our need for additional capital which may not be available on commercially acceptable terms, if at all, which raises questions about our ability to continue as a going concern; the fact that the COVID-19 pandemic has had, and is expected to continue to have, a significant material adverse impact on the travel industry and our business, operating results and liquidity; current regulation governing digital currency activity is often unclear and is evolving; the future development and growth of digital currencies are subject to a variety of factors that are difficult to predict and evaluate, many of which are out of our control; the value of digital currency is volatile; amounts owed to us by third parties which may not be paid timely, if at all; certain amounts we owe under outstanding indebtedness which are secured by substantially all of our assets and penalties we may incur in connection therewith; the fact that we have significant indebtedness, which could adversely affect our business and financial condition; our revenues and results of operations being subject to the ability of our distributors and partners to integrate our alternative lodging rental (ALR) properties with their websites, and the timing of such integrations; uncertainty and illiquidity in credit and capital markets which may impair our ability to obtain credit and financing on acceptable terms and may adversely affect the financial strength of our business partners; the officers and directors of the Company have the ability to exercise significant influence over the Company; stockholders may be diluted significantly through our efforts to obtain financing, satisfy obligations and complete acquisitions through the issuance of additional shares of our common or preferred stock; if we are unable to adapt to changes in technology, our business could be harmed; our travel business depends substantially on property owners and managers renewing their listings; if we do not adequately protect our intellectual property, our ability to compete could be impaired; our long-term success depends, in part, on our ability to expand our property owner, manager and traveler bases outside of the United States and, as a result, our business is susceptible to risks associated with international operations; unfavorable changes in, or interpretations of, government regulations or taxation of the evolving ALR, Internet and e-commerce industries which could harm our operating results; risks associated with the operations of, the business of, and the regulation of, Longroot and NextBank International (formerly IFEB); the market in which we participate being highly competitive, and because of that we may be unable to compete successfully with our current or future competitors; our potential inability to adapt to changes in technology, which could harm our business; the volatility of our stock price; the fact that we may be subject to liability for the activities of our property owners and managers, which could harm our reputation and increase our operating costs; and that we have incurred significant losses to date and require additional capital which may not be available on commercially acceptable terms, if at all. More information about the risks and uncertainties faced by NextPlay are detailed from time to time in NextPlay's periodic reports filed with the SEC, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors". These reports are available at www.sec.gov. Other unknown or unpredictable factors also could have material adverse effects on the Company's future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements. Investors are cautioned that any forward-looking statements are not guarantees of future performance and actual results or developments may differ materially from those projected. The forward-looking statements in this press release are made only as of the date hereof. The Company takes no obligation to update or correct its own forward-looking statements, except as required by law, or those prepared by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
SOURCE: NextPlay Technologies, Inc.
Company Contacts:
NextPlay Technologies, Inc.
Richard Marshall
Director of Corporate Development
Tel: (954) 888-9779
Email: [email protected]
Ample Health
Akira Wongwan
Founder
Tel: 0869778788
Email: [email protected]
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comNextPlay Technologies, Inc. (NASDAQ: NXTP), a digital business ecosystem for digital advertisers, consumers, video gamers and travelers, reported that its licensed Longroot digital token offering platform will serve as the financial advisor and underwriter for Ample Health's ('Ample') proposed security token offering (STO).
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