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  • ||||||||||  timbetasin topical (RGN-137) / RegeneRx, timbetasin ophthalmic (RGN-259) / ReGenTree
    Journal:  Thymosin beta 4: A potential novel adjunct treatment for bacterial keratitis. (Pubmed Central) -  Apr 25, 2023   
    Our previous work has shown that topical T?4 as an adjunct to ciprofloxacin treatment reduces inflammatory mediators and inflammatory cell infiltrates (neutrophils/PMN and macrophages) while enhancing bacterial killing and wound healing pathway activation in an experimental model ofP...Adjunctive thymosin beta 4 treatment holds novel therapeutic potential to regulate and, optimally, resolve disease pathogenesis in the cornea and perhaps other infectious and immune-based inflammatory disease. We plan to establish the importance of thymosin beta 4 as a therapeutic agent in conjunction with antibiotics with high impact for immediate clinical development.
  • ||||||||||  timbetasin intravenous (RGN-352) / RegeneRx
    Preclinical, Journal:  Thymosin beta 4 prevents systemic lipopolysaccharide-induced plaque load in middle-age APP/PS1 mice. (Pubmed Central) -  Apr 4, 2023   
    It prevented LPS-induced amyloid burden in APP/PS1 mice but increased astrocytic and microglial proliferation in the hippocampus of LPS-treated WT mice. These data show that T?4 can alleviate the adverse effects of systemic LPS in the brain by preventing exacerbation of amyloid deposition in AD mice and by inducing reactive microgliosis in aging WT mice.
  • ||||||||||  timbetasin intravenous (RGN-352) / RegeneRx
    Journal:  Thymosin beta-4 denotes new directions towards developing prosperous anti-aging regenerative therapies. (Pubmed Central) -  Mar 9, 2023   
    Moreover, we discovered TB4 is capable of epicardial progenitor activation, and revealed the effect is independent of hypoxic injury. By observing the above results, we believe, further discoveries and consequential postnatal administration of developmentally relevant candidate molecules such as TB4 may likely result in reversing aging processes and accelerate organ regeneration in the human body.
  • ||||||||||  timbetasin topical (RGN-137) / RegeneRx
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) -  Aug 22, 2022   
    P2,  N=4, Terminated, 
    In summary, the use of 0.1% RGN-259 promotes rapid healing of epithelial defects in neurotrophic keratopathy, improves ocular comfort, and is safe for treating this challenging population of patients. N=15 --> 4 | Trial completion date: Jun 2022 --> Nov 2021 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Sep 2021; Business Decision
  • ||||||||||  timbetasin intravenous (RGN-352) / REGENXBIO
    Enhancing cardiac regenerative therapies by reminding the adult heart on its embryonic state (ePoster station 6) -  Mar 12, 2022 - Abstract #HEARTFAILURE2022HEART_FAILURE_390;    
    Observing the broad capacity of TB4 we believe it is not the only molecule which nature conceals to our benefits. Hence, the discovery and postnatal administration of developmentally relevant agents along with other approaches may even result in reversing aging processes.
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    SEER-1 Demonstrates Safety and Efficacy of RGN-259 for Neurotrophic Keratopathy (Morial Convention Center) -  Oct 20, 2021 - Abstract #AAO2021AAO_1782;    
    No treatment emergent adverse events led to study discontinuation. Conclusions In a small study, the efficacy and safety of RGN-259 validate that RGN-259 represents a potential first-line therapy for NK.
  • ||||||||||  timbetasin intravenous (RGN-352) / REGENXBIO
    [VIRTUAL] Oxytocin Mediates Neuroendocrine Reprogramming of the Epicardium in Heart Regeneration () -  Jul 26, 2020 - Abstract #BCVS2020BCVS_250;    
    Future studies will aim to further reveal the physiological contribution of OT to heart regeneration in vivo and determine its molecular mechanism of action. Our findings have the potential to uncover a novel mechanism of neuroendocrine reprogramming of the injured heart and yield significant translational advances in the treatment of CVD.
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 (clinicaltrials.gov) -  Jul 2, 2020   
    P3,  N=18, Terminated, 
    Our findings have the potential to uncover a novel mechanism of neuroendocrine reprogramming of the injured heart and yield significant translational advances in the treatment of CVD. N=46 --> 18 | Trial completion date: Sep 2020 --> Mar 2020 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Nov 2019; Business decision
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (clinicaltrials.gov) -  Jun 1, 2020   
    P3,  N=700, Recruiting, 
    N=46 --> 18 | Trial completion date: Sep 2020 --> Mar 2020 | Recruiting --> Terminated | Trial primary completion date: Aug 2020 --> Nov 2019; Business decision Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Apr 2020 --> Aug 2020
  • ||||||||||  timbetasin intravenous (RGN-352) / REGENXBIO
    Preclinical, Journal:  Protective Effect of Thymosin β4 against Abdominal Aortic Ischemia-Reperfusion-Induced Acute Lung Injury in Rats. (Pubmed Central) -  Dec 20, 2019   
    Tβ4 reverted these parameters in both Tβ4-treated groups compared to the untreated IR group. Since there is no statistical difference between the prescribed results of both Tβ4-treated groups, our study demonstrates that Tβ4 reduced lung oxidative stress and inflammation following IR and prevented lung tissue injury regardless of timing of administration.
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 (clinicaltrials.gov) -  Sep 9, 2019   
    P3,  N=46, Recruiting, 
    In conclusion, RGN-259 promoted recovery of mucins and goblet cells, improved corneal integrity, and reduced inflammation in a dry eye mouse model and was equal to or more effective than prescription treatments. Trial completion date: Aug 2019 --> Sep 2020 | Trial primary completion date: May 2019 --> Aug 2020
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion, Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (clinicaltrials.gov) -  Sep 7, 2018   
    P3,  N=601, Completed, 
    Trial completion date: Nov 2018 --> Aug 2019 | Trial primary completion date: Sep 2018 --> May 2019 Active, not recruiting --> Completed | Trial completion date: Nov 2018 --> Mar 2018 | Trial primary completion date: Nov 2018 --> Sep 2017
  • ||||||||||  timbetasin ophthalmic (RGN-259) / ReGenTree
    Trial completion date, Trial primary completion date:  Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 (clinicaltrials.gov) -  Apr 17, 2018   
    P3,  N=601, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Nov 2018 --> Mar 2018 | Trial primary completion date: Nov 2018 --> Sep 2017 Trial completion date: Nov 2017 --> Nov 2018 | Trial primary completion date: Nov 2017 --> Nov 2018
  • ||||||||||  timbetasin intravenous (RGN-352) / RegeneRx
    Enrollment change, Trial withdrawal, Trial primary completion date:  A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers (clinicaltrials.gov) -  Apr 17, 2017   
    P1,  N=0, Withdrawn, 
    Trial primary completion date: May 2017 --> Jan 2018 N=60 --> 0 | Completed --> Withdrawn | Trial primary completion date: Oct 2009 --> Jan 2017