3K3A-APC / ZZ Biotech 
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  • ||||||||||  3K3A-APC / ZZ Biotech
    Intravenous 3K3A-Activated Protein C Inhibits Murine Ocular Inflammation and Suppresses Ocular Choroidal Neovascularization (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_3537;    
    Drawing insights from the neuroprotective activities of 3K3A-APC in the brain and CNS and recognizing the retina, particularly the macula, as an extension of the brain, we propose 3K3A-APC as a potential neuroprotective treatment for AMD and other neurodegenerative retinal pathologies. Given the established safety of systemic 3K3A-APC administration in phase 2 clinical trials for ischemic stroke, our findings support further exploring 3K3A-APC as a novel therapeutic approach in ophthalmology.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial initiation date, Combination therapy:  RHAPSODY-2: Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Jul 12, 2023   
    P3,  N=1400, Not yet recruiting, 
    Our study suggests the potential use of 3K3A-APC as a novel multi-target treatment for CNV. Initiation date: Apr 2023 --> Dec 2023
  • ||||||||||  3K3A-APC / ZZ Biotech
    Journal:  Analysis of Brain Edema in RHAPSODY. (Pubmed Central) -  Jun 29, 2023   
    Existing cerebral edema imaging markers potentially describe two distinct processes, including lesional water concentration (i.e., NWU) and mass effect (MLS, HVR, and CSF volume). These two types of imaging markers may represent distinct aspects of cerebral edema, which could be useful for future trials targeting this process.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Preclinical, Journal:  Analysis of the urinary metabolic profiles in irradiated rats treated with Activated Protein C (APC), a potential mitigator of radiation toxicity. (Pubmed Central) -  Feb 24, 2023   
    On the other hand, sub-cohorts of rats that were treated with rat wildtype-APC showed alleviation of radiation toxicities, in part, at the 90-day time point, while rat 3K3A-APC showed partial alleviation of radiation induced metabolic alterations 14?days after irradiation. Taken together, these results show that augmenting the Protein C pathway and activity via administration of recombinant APC may be an effective approach for mitigation of radiation induced normal tissue toxicity.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Parmodulin, an Allosteric Inhibitor of Protease Activated Receptor 1 (PAR1) Protects Sickle Cell Mice from Thromboinflammation and Endothelial Dysfunction (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_3773;    
    3K3A-APC is a signaling selective variant of APC that activates cytoprotective PAR1 signaling with minimal anticoagulant effects, demonstrated to have a beneficial role in stroke models...In contrast, PM2-mediated allosteric inhibition of thrombin/PAR1 and simultaneous induction of APC-like cytoprotective signaling attenuated levels of TAT, IL-6, HMGB1, and sVCAM in HbSS mice. Future studies towards evaluating the effect of PM2 on downstream targets of PAR1 signaling in sickle mice will provide more insight into the mechanism of this protective effect.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Activated protein C analog protects pericyte-deficient mice from ischemic brain injury (SDCC Halls B-H) -  Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_4247;    
    Our data suggest that pericyte deficiency results in greater brain injury, BBB breakdown, and neuronal degeneration in stroked mice and that 3K3A-APC protects the brain from accelerated injury caused by pericyte deficiency. These findings may have implications for treatment of ischemic brain injury in neurological conditions associated with pericyte loss such as those seen during normal aging and in neurodegenerative disorders such as Alzheimer's disease.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial completion:  3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Sep 28, 2022   
    P2,  N=16, Completed, 
    These findings may have implications for treatment of ischemic brain injury in neurological conditions associated with pericyte loss such as those seen during normal aging and in neurodegenerative disorders such as Alzheimer's disease. Recruiting --> Completed
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial completion date, Trial primary completion date:  3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Aug 24, 2022   
    P2,  N=16, Recruiting, 
    Thus, p21-dependent tubular senescence is a pathway contributing to the hyperglycemic memory, which can be therapeutically targeted. Trial completion date: Mar 2022 --> Sep 2022 | Trial primary completion date: Mar 2022 --> Sep 2022
  • ||||||||||  3K3A-APC / ZZ Biotech
    Rhapsody-2: A Phase 3 Study Of 3K3A-APC In Acute Ischemic Stroke (Hall B2, Poster Hall; Board No. CTP19) -  Feb 22, 2022 - Abstract #ISC2022ISC_1739;    
    The primary outcome is 90-day disability measured by modified Rankin score (mRS) using ordinal (shift) analysis. Secondary analyses include additional behavioral outcomes, lesion morphometry, and qualify of life measures.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Journal:  Cerebroprotection for Acute Ischemic Stroke: Looking Ahead. (Pubmed Central) -  Jan 11, 2022   
    Examples of pleiotropic treatments include therapeutic hypothermia and 3K3A-APC (activated protein C)...Before clinical trials, preclinical assessment could include subjects that are aged, of both sexes, and harbor comorbid conditions such as diabetes or hypertension. With these new definitions, novel approaches, and renewed attention to rigor, the prospect for successful cerebroprotective therapy should improve.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Preclinical, Journal:  Protection of ischemic white matter and oligodendrocytes in mice by 3K3A-activated protein C. (Pubmed Central) -  Jan 4, 2022   
    We show that PAR1 and PAR3 were also required for 3K3A-APC's suppression of post-WM stroke microglia and astrocyte responses and overall improvement in neuropathologic and functional outcomes. Our data provide new insights into the neuroprotective APC pathway in the WM and illustrate 3K3A-APC's potential for treating WM stroke in humans, possibly including multiple WM strokes that result in vascular dementia.
  • ||||||||||  3K3A-APC / ZZ Biotech
    Enrollment open:  3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Dec 6, 2021   
    P2,  N=16, Recruiting, 
    Our data provide new insights into the neuroprotective APC pathway in the WM and illustrate 3K3A-APC's potential for treating WM stroke in humans, possibly including multiple WM strokes that result in vascular dementia. Not yet recruiting --> Recruiting
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial completion date, Combination therapy:  RHAPSODY: Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Nov 8, 2018   
    P2,  N=110, Completed, 
    Not yet recruiting --> Recruiting Trial completion date: Oct 2017 --> Jun 2017
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial completion, Combination therapy:  RHAPSODY: Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Jan 11, 2018   
    P2,  N=110, Completed, 
    Trial completion date: Oct 2017 --> Jun 2017 Active, not recruiting --> Completed
  • ||||||||||  3K3A-APC / ZZ Biotech
    Enrollment closed, Combination therapy:  RHAPSODY: Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Apr 10, 2017   
    P2,  N=110, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  3K3A-APC / ZZ Biotech
    Trial primary completion date, Combination therapy:  RHAPSODY: Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Mar 15, 2017   
    P2,  N=100, Recruiting, 
    Recruiting --> Active, not recruiting Trial primary completion date: Mar 2017 --> Jul 2017
  • ||||||||||  3K3A-APC / ZZ Biotech
    Enrollment open, Combination therapy:  RHAPSODY: Safety Evaluation of 3K3A-APC in Ischemic Stroke (clinicaltrials.gov) -  Oct 22, 2014   
    P2,  N=100, Recruiting, 
    Trial primary completion date: Mar 2017 --> Jul 2017 Not yet recruiting --> Recruiting