CNM-Au8 / Clene 
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  • ||||||||||  CNM-Au8 / Clene
    Evidence for long-term survival benefit in ALS with CNMAu8 treatment across three study populations (Poster Hall at the Palais de Congres Montreal; 517b/c) -  Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_596;    
    Long-term follow-up from RESCUE-ALS and the HEALEY ALS Platform Trial provide evidence for improved survival with CNM-Au8 30mg. These findings from long-term follow-up of the two clinical studies are reinforced by real-world data from the compassionate use EAPs.
  • ||||||||||  CNM-Au8 / Clene
    Review, Journal:  The Evolving Use of Gold Nanoparticles as a Possible Reversal Agent for the Symptoms of Neurodegenerative Diseases: A Narrative Review. (Pubmed Central) -  Aug 19, 2024   
    In vitro studies of CNM-Au8 (Clene Nanomedicine, Salt Lake City, UT) have been shown to reduce TDP-43 aggregates associated with ALS...As the current data repeatedly suggest, these gold nanoparticles are efficacious for the treatment and reversal of symptoms across these varying neurodegenerative pathologies. Further opportunities exist for increasing human trials and eventually incorporating this new technology into existing treatment regimens.
  • ||||||||||  Huntexil (pridopidine) / Prilenia, CNM-Au8 / Clene, verdiperstat (BHV-3241) / Biohaven
    Clinical, Journal:  Multicenter expanded access program for access to investigational products for amyotrophic lateral sclerosis. (Pubmed Central) -  Jul 3, 2024   
    Further opportunities exist for increasing human trials and eventually incorporating this new technology into existing treatment regimens. Multicenter EAPs conducted in parallel to randomized clinical trials for ALS can successfully enroll participants who do not qualify for clinical trials.
  • ||||||||||  Enrollment closed:  HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) -  May 14, 2024   
    P2/3,  N=1500, Active, not recruiting, 
    Multicenter EAPs conducted in parallel to randomized clinical trials for ALS can successfully enroll participants who do not qualify for clinical trials. Recruiting --> Active, not recruiting
  • ||||||||||  CNM-Au8 / Clene
    Journal:  Protein Corona Composition of Gold Nanocatalysts. (Pubmed Central) -  Apr 18, 2024   
    Our study delves into the mechanisms by which colloidal Au nanocrystals that are synthesized electrochemically without surface-capping organic ligands, known as CNM-Au8, traverse the blood-brain barrier (BBB) and target human brain tissue for treating neurodegenerative disorders...This study highlights that AuNCs with intentionally engineered structures and surfactant-free surfaces can create a distinct protein corona composition. This finding holds significant promise for the development of advanced therapeutic agents aimed at combating neurodegenerative diseases.
  • ||||||||||  CNM-Au8 / Clene
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  VISIONMS-LTE: A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis (clinicaltrials.gov) -  Dec 8, 2023   
    P2/3,  N=55, Completed, 
    Our results demonstrate brain target engagement of CNM-Au8 as a direct modulator of brain energy metabolism, and support the further investigation of CNM-Au8 as a potential disease modifying drug for PD and MS. Active, not recruiting --> Completed | N=150 --> 55 | Trial completion date: Aug 2024 --> Sep 2023 | Trial primary completion date: Jun 2024 --> May 2023
  • ||||||||||  CNM-Au8 / Clene
    Journal:  A Mechanism Underpinning the Bioenergetic Metabolism-Regulating Function of Gold Nanocatalysts. (Pubmed Central) -  Sep 28, 2023   
    Photoexcited charge carriers and photothermal effect, which result from optical excitations and decay of the plasmonic electron oscillations or the interband electronic transitions in CNM-Au8, are further harnessed as unique leverages to modulate reaction kinetics. As exemplified by this work, Au nanocrystals with deliberately tailored structures and surfactant-free clean surfaces hold great promise for developing next-generation therapeutic agents for neurodegenerative diseases.
  • ||||||||||  CNM-Au8 / Clene
    Journal:  Nanocrystalline gold (CNM-Au8): a novel bioenergetic treatment for ALS. (Pubmed Central) -  Sep 23, 2023   
    As exemplified by this work, Au nanocrystals with deliberately tailored structures and surfactant-free clean surfaces hold great promise for developing next-generation therapeutic agents for neurodegenerative diseases. No abstract available
  • ||||||||||  CNM-Au8 / Clene
    Review, Journal:  CNM-Au8: An experimental agent for the treatment of amyotrophic lateral sclerosis (ALS). (Pubmed Central) -  Aug 29, 2023   
    The two established disease-specific therapies for the treatment of amyotrophic lateral sclerosis (ALS) are riluzole and edaravone...AMX0035 and tofersen received US FDA approval in September 2022 and April 2023, respectively...Despite this failure, a number of exploratory endpoints included in phase 2/3 trials suggest CNM-Au8 has the potential to significantly slow clinical worsening, improve quality of life, and prolong survival in ALS. Further study of CNM-Au8 in a phase 3 clinical trial is currently underway.
  • ||||||||||  CNM-Au8 / Clene
    Trial completion:  HEALEY ALS Platform Trial - Regimen C CNM-Au8 (clinicaltrials.gov) -  Jul 27, 2023   
    P2/3,  N=161, Completed, 
    Further study of CNM-Au8 in a phase 3 clinical trial is currently underway. Active, not recruiting --> Completed
  • ||||||||||  Trial completion date, Trial primary completion date:  HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) -  May 16, 2023   
    P2/3,  N=1500, Recruiting, 
    Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Apr 2024 Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Jul 2025
  • ||||||||||  Enrollment change, Trial completion date, Trial primary completion date:  HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) -  Apr 10, 2023   
    P2/3,  N=1200, Recruiting, 
    Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Jul 2025 N=800 --> 1200 | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Apr 2023 --> Apr 2025
  • ||||||||||  CNM-Au8 / Clene
    CNM-Au8 Phase 2 VISIONARY-MS Trial Results () -  Nov 20, 2022 - Abstract #AECF2022AECF_31;    
    There were no serious adverse events assessed as related to CNM-Au8. These data provide evidence for improved neurological function in stable RMS patients treated with CNM-Au8 as adjunct to standard-of-care and support continued investigation of CNM-Au8.
  • ||||||||||  CNM-Au8 / Clene Nanomedicine
    Improvement of Brain Energy Metabolism in Relapsing Multiple Sclerosis Patients - Results from Phase 2 REPAIR-MS Clinical Trial With CNM-Au8 (Exhibit Hall A) -  Feb 20, 2022 - Abstract #ACTRIMSForum2022ACTRIMS_Forum_252;    
    7-Tesla 31phosphorous magnetic resonance spectroscopy (31P-MRS) was used to assess levels of brain energy metabolites including NAD+, NADH, ATP (beta, alpha, and gamma), and phospho-mono and diesters in 13 MS natalizumab treated patients receiving CNM-Au8 under an IRB approved protocol. Results from this newly completed study provide the first clinical evidence of CNM-Au8 treatment effects on brain bioenergetic metabolism and support its candidacy as a disease-modifying drug for MS.
  • ||||||||||  Enrollment open:  HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) -  Feb 15, 2022   
    P2/3,  N=800, Recruiting, 
    Results from this newly completed study provide the first clinical evidence of CNM-Au8 treatment effects on brain bioenergetic metabolism and support its candidacy as a disease-modifying drug for MS. Active, not recruiting --> Recruiting
  • ||||||||||  Enrollment closed, Trial completion date, Trial primary completion date:  HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) -  Feb 4, 2022   
    P2/3,  N=800, Active, not recruiting, 
    Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Dec 2023 | Trial primary completion date: Mar 2022 --> Apr 2023