Publications by authors named "T J Povsic"

Background: XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment) assessed the safety and preliminary efficacy of XC001 in patients with no option refractory angina.

Methods: In this single-arm, multicenter, open-label trial, 32 patients with no option refractory angina received a single treatment of XC001 (1×10 viral particles) via transepicardial delivery.

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  • * The study involved over 18,000 patients who were randomly assigned to receive either CSL112 or a placebo, showing that CSL112 resulted in a numerical decrease in rates of cardiovascular death and recurrent MIs over 1 year.
  • * While CSL112 did not significantly meet the primary endpoint goals, the results suggest it may help reduce the risk of heart-related complications, indicating a potential benefit of apoA-I in managing cholesterol and plaque stability in at-risk patients.
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Background: Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear.

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  • Heart failure patients struggle with daily activities and have a low quality of life, which necessitates more than just tracking deaths and hospitalizations to measure treatment effectiveness.
  • In the CHART-1 trial, both cell therapy and placebo showed similar improvements in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), although cell therapy benefited a specific subgroup with advanced heart conditions.
  • The study suggests that cell therapy may enhance quality of life and reduce hospitalizations in certain patients, indicating the need for more research to validate these findings and potentially improve heart failure management.
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Background: New therapies are needed for patients with refractory angina. Encoberminogene rezmadenovec (XC001), a novel adenoviral-5 vector coding for all 3 major isoforms of VEGF (vascular endothelial growth factor), demonstrated enhanced local angiogenesis in preclinical models; however, the maximal tolerated dose and safety of direct epicardial administration remain unknown.

Methods: In the phase 1 portion of this multicenter, open-label, single-arm, dose-escalation study, patients with refractory angina received increasing doses of encoberminogene rezmadenovec (1×10, 1×10, 4×10, and 1×10 viral particles) to evaluate its safety, tolerability, and preliminary efficacy.

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