eClinical Technology and Industy News

XyloCor Therapeutics Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023

– Positive Phase 2 EXACT Trial results at 6-months underscore significant potential of investigational therapy in refractory angina

– Six-month data have since been sustained out to 12-months supporting durability of XC001 safety and efficacy profile

– XC001 targets unmet medical need among patients with refractory angina who have a debilitating quality-of-life burden and no available treatment options

Excerpt from the Press Release:

WAYNE, PA.–(BUSINESS WIRE)–XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the European Society of Cardiology (ESC) Congress 2023. During the ESC Congress poster session, Dr. Thomas Povsic, Principal Investigator of the EXACT trial, presented the primary six-month outcome data from the recently completed EXACT trial, which demonstrated that treatment with XC001 resulted in improvements across all key efficacy endpoints. The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.

XC001 is a one‑time gene therapy designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor (VEGF) isoforms. In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through transepicardial delivery (direct administration to the heart). XC001 met all of its safety and exploratory objectives and showed potential transformative benefits for the patient population. Among the notable topline results presented at the ESC Congress 2023 included:

  • VEGF gene therapy with XC001 administered via minimally invasive transepicardial delivery was generally well tolerated.
  • There were no serious adverse events related to the drug or unexpected serious adverse events related to XC001 administration.

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