EDSS

ETNA™ DEVICE FROM THE LEADING DIGITAL HEALTH & AI COMPANY INNODEM NEUROSCIENCES RECEIVES FDA "BREAKTHROUGH" DESIGNATION FOR MULTIPLE SCLEROSIS

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星期二, 五月 31, 2022

"Eye tracking technology has been around for decades, and the literature demonstrates that eye movements can serve as powerful markers of brain health, particularly in MS.

Key Points: 
  • "Eye tracking technology has been around for decades, and the literature demonstrates that eye movements can serve as powerful markers of brain health, particularly in MS.
  • However, this technology was complex to use, expensive, and the data collected did not allow clinicians to benefit from it for their patients.
  • Up until now, with current standard of care in MS, several years are usually required before clinicians confidently establish the presence of disease progression.
  • www.innodemneurosciences.com
    MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm.

ETNA™ DEVICE FROM THE LEADING DIGITAL HEALTH & AI COMPANY INNODEM NEUROSCIENCES RECEIVES FDA "BREAKTHROUGH" DESIGNATION FOR MULTIPLE SCLEROSIS

Retrieved on: 
星期二, 五月 31, 2022

"Eye tracking technology has been around for decades, and the literature demonstrates that eye movements can serve as powerful markers of brain health, particularly in MS.

Key Points: 
  • "Eye tracking technology has been around for decades, and the literature demonstrates that eye movements can serve as powerful markers of brain health, particularly in MS.
  • However, this technology was complex to use, expensive, and the data collected did not allow clinicians to benefit from it for their patients.
  • Up until now, with current standard of care in MS, several years are usually required before clinicians confidently establish the presence of disease progression.
  • www.innodemneurosciences.com
    MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm.

IASO Biotherapeutics' Equecabtagene Autoleucel, the World's First CAR-T for Treatment of NMOSD, Receives IND Application Acceptance by NMPA

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星期六, 五月 28, 2022

This NMPA acceptance, the world's first IND application for CAR-T in NMOSD.

Key Points: 
  • This NMPA acceptance, the world's first IND application for CAR-T in NMOSD.
  • IASO Bio's IND application is based on the Equecabtagene AutoleucelInvestigator Initiated Trial (IIT) enrolling patients with refractory NMOSD who were positive for Aquaporin 4 antibodies (AQP4).
  • Subjects enrolled were patients with poor symptom control despite at least one year of treatment with at least one immunosuppressant.
  • "Theuse of CAR-T cell products has been widely accepted in the treatment of hematologic malignancy but has been rarely reported in the treatment of autoimmune diseases.

MEET THE ALL-NEW LEXUS RZ, THE LUXURY BRAND'S FIRST BATTERY EV

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星期三, 四月 20, 2022

PLANO, Texas, April 20, 2022 /PRNewswire/ -- Lexus is proud to unveil details of the all-new 2023 RZ 450e, the luxury brand's first global Battery EV (BEV).

Key Points: 
  • Since the launch of the RX400h in 2005, Lexus has been a pioneer of electrification within the luxury market.
  • This styling evolution ushers in a new Lexus aesthetic and establishes a new design direction for BEV offerings.
  • The "Lexus Driving Signature" (LDS) is a uniquely Lexus driving experience that aims to achieve predictable, linear response according to the driver's intentions.
  • In the RZ,the high-precision motor torque control and optimal battery and motor placement help to achieve ideal weight distribution and high response.

TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis Presented at the American Academy of Neurology Annual Meeting

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星期一, 四月 4, 2022

NEW YORK, April 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc.(NASDAQ: TGTX),today announced data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented over the weekend at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington.

Key Points: 
  • NEW YORK, April 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc.(NASDAQ: TGTX),today announced data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), presented over the weekend at the American Academy of Neurology (AAN) annual meeting, held in Seattle, Washington.
  • The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries.
  • We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
  • The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Tiziana Announces Positive Clinical Data from A Secondary Progressive Multiple Sclerosis Patient Treated for Six Months with Intranasally Administered Foralumab, A Fully Human Anti-CD3 Monoclonal Antibody

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星期四, 三月 10, 2022

Consistent with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines, including interferon-gamma (IFN-g), interleukin (IL-18), IL-1 and IL-6, which are associated with multiple sclerosis pathogenesis and progression.

Key Points: 
  • Consistent with clinical and PET observations, intranasally administered foralumab also downregulated serum levels of pro-inflammatory cytokines, including interferon-gamma (IFN-g), interleukin (IL-18), IL-1 and IL-6, which are associated with multiple sclerosis pathogenesis and progression.
  • Clinical evaluation showed improvement in Timed 25-Foot Walk Test (T25FW), 9-Hole Peg Test (9HPT) and Symbol Digit Modality Test (SDMT).
  • We are extremely pleased with the tolerability of intranasal foralumab and with the positive clinical and PET imaging responses observed after completion of six months of dosing in the first patient.
  • The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made.

Clene Nanomedicine Presents Data from Two Phase 2 Multiple Sclerosis Trials at ACTRIMS Forum 2022

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星期四, 二月 24, 2022

These data further support Clenes lead drug candidate, CNM-Au8, a catalytically active gold nanocrystal suspension, as a potential disease-modifying therapy for Multiple Sclerosis (MS).

Key Points: 
  • These data further support Clenes lead drug candidate, CNM-Au8, a catalytically active gold nanocrystal suspension, as a potential disease-modifying therapy for Multiple Sclerosis (MS).
  • These data support CNM-Au8s potential to drive meaningful neurological improvements in stable relapsing MS patients.
  • We look forward to sharing the unblinded data from VISIONARY-MS in the second half of 2022 that will help inform the design of our next clinical trial in MS patients.
  • CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization.

AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the Swedish Medical Products Agency

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星期三, 二月 2, 2022

AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
  • To date, masitinib has demonstrated positive Phase 2B/3 results in three neurodegenerative disorders, namely, Alzheimers disease [1], amyotrophic lateral sclerosis (ALS) [2,3], and progressive forms of multiple sclerosis [4].
  • This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis.
  • Published 2021 Jul 19. doi:10.1177/17562864211030365
    [4] Vermersch P, Hermine O. Masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis: results from phase 3 study AB07002.

Air Cargo Security and Screening Systems Market Forecast to 2028 - ResearchAndMarkets.com

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星期四, 一月 27, 2022

The "Air Cargo Security and Screening Systems Market Forecast to 2028 - COVID-19 Impact and Global Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Air Cargo Security and Screening Systems Market Forecast to 2028 - COVID-19 Impact and Global Analysis" report has been added to ResearchAndMarkets.com's offering.
  • Moreover, the rising use of air cargo facilities for the transportation of goods is leading to the increasing use of these cargo screening technologies for enabling quicker checks.
  • The escalating deployment of security screening systems and rising transportation of temperature-sensitive products are influencing the demand for global air cargo security and screening systems.
  • However, the lack of technical expertise is restraining the global air cargo security and screening systems market growth.

Tiziana Enrolls Second Patient in Ongoing Intranasal Foralumab Evaluation for Secondary Progressive Multiple Sclerosis

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星期一, 一月 10, 2022

NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, is pleased to announce that the U.S. Food and Drug Administration (FDA) allowed enrollment of a second patient in the ongoing clinical treatment of secondary progressive multiple sclerosis (SPMS) with intranasally administered foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women’s Hospital (BWH), Harvard University, Boston, MA.

Key Points: 
  • Treatment of the second patient is expected to begin during January 2022 with interim clinical data after 3 out of 6 months of treatment expected in April 2022.
  • The Investigators at BWH will be monitoring detailed safety, neurological, and Positron Emission Tomography (PET) to evaluate microglial activation in this patient.
  • The ongoing treatment of the first patient continues, and six months of dosing is expected to be completed by the end of March 2022.
  • To date, this patient has not shown signs of treatment intolerance or toxicities and appears to be responding well to treatment.