NSVT

Tenaya Therapeutics Announces FDA Clearance to Begin Clinical Testing of TN-401 Gene Therapy for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

Retrieved on: 
Thursday, October 26, 2023
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SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of the company’s Investigational New Drug (IND) application to initiate clinical testing of TN-401.

Key Points: 
  • TN-401 is Tenaya’s adeno-associated virus serotype 9 (AAV9)-based investigational gene therapy product candidate for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the plakophilin-2 (PKP2) gene.
  • Tenaya is currently conducting the RIDGE™ global non-interventional natural history and serotype study of PKP2-associated ARVC.
  • ARVC, also known as arrhythmogenic cardiomyopathy (ACM), is a chronic, progressive, familial disease that typically presents before age 40.
  • People with ARVC experience symptoms related to ventricular arrhythmias, including palpitations, lightheadedness and fainting, and are at increased risk of sudden cardiac death.

New Data From iRhythm Reinforce the Utility of Long-Term Ambulatory Cardiac Monitoring for Increased Diagnostic Yield and Improved Diagnostic Accuracy of Actionable Arrhythmias

Retrieved on: 
Monday, May 22, 2023
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These new data reinforce the body of clinical evidence that long-term ambulatory cardiac monitoring of up to 14 days with Zio® XT increases diagnostic yield and improves diagnostic accuracy of ventricular arrhythmias across a wide range of patient populations.

Key Points: 
  • These new data reinforce the body of clinical evidence that long-term ambulatory cardiac monitoring of up to 14 days with Zio® XT increases diagnostic yield and improves diagnostic accuracy of ventricular arrhythmias across a wide range of patient populations.
  • Early detection and diagnosis are crucial to treating these arrhythmias and preventing adverse health outcomes.
  • At least seven days of continuous ambulatory ECG monitoring, performed by the Zio service, was necessary to achieve >95% accuracy in burden categorization.
  • In this randomized, placebo-controlled, crossover trial of 41 patients that received Zio XT ambulatory ECG monitoring for seven days, Flecainide significantly reduced PVC burden.