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news.Fibrocell Science announced that the last patient visit for primary endpoint analysis has been completed in its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia.
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Fibrocell’s azficel-T has the potential to address the underlying cause of chronic dysphonia by using the patient’s own cells for localized treatment of the scarred vocal cords to improve voice quality.
"Achieving this milestone in our Phase II trial is significant in the development of azficel-T for the treatment of vocal cord scarring resulting in chronic dysphonia," said David Pernock, Chairman and Chief Executive Officer of Fibrocell.
"This accomplishment acknowledges the progress in our pipeline of personalized biologics and our hope to deliver a treatment that could restore the voices of patients whose ability to speak has been compromised or lost."
Vocal cord scarring is caused by damage to the fibroblast layer of the vocal cords which reduces vocal cord elasticity and airflow, affecting voice tone and volume. This reduction in vocal capacity is referred to as dysphonia, severe cases of which can lead to a total loss of voice. Current treatments for vocal cord scarring, which include voice therapy and surgery through the use of injection (collagen, fat, calcium, hyaluronic acid) or implant (PTFE, silastic), only address the symptoms of vocal cord scarring and have inconsistent efficacy.
Fibrocell’s azficel-T has the potential to address the underlying cause of vocal cord scarring by restoring the extracellular matrix to repair damage to the fibroblast layer of the vocal cords, resulting in improved voice quality.
Fibrocell’s Phase II study is a double-blind, randomized, placebo-controlled trial designed to test the safety and efficacy of azficel-T injections in subjects with chronic dysphonia caused by idiopathic vocal fold scarring or atrophy.
Primary efficacy is being assessed at four months post last treatment on three different scales: Voice Handicap Index, Mucosal Wave Grade and GRBAS, or grade, roughness, breathiness, asthenia and strain. Fibrocell expects to report primary endpoint results for this Phase II trial in the second quarter of 2016.