Fibrocell Plunges 40% After Second Stage azficel-T Trial Fails To Meet Primary Endpoints

Fibrocell Science, Inc. FCSC revealed that the primary endpoints were not met in its second stage clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia. According to the company, it plans to focus its efforts on the development of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa and its earlier stage programs.

The stock plunged 40.5 percent to $1.23.

Fibocell chairman and CEO, David Pernock, said, "We are disappointed that azficel-T did not demonstrate the anticipated benefits for patients in this Phase II clinical trial. While we will continue to assess the data to gain greater insight into the study's outcome and follow these patients through the final (unblinded) 12-month endpoint, we believe this trial was well conducted and addressed the objectives it was designed to evaluate. We are grateful for the support of the patients, investigators and staff who participated in the trial."

The company's second stage study was 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 cord scarring or atrophy. The company added that primary efficacy endpoints were assessed at four months post last treatment on three different scales: Voice Handicap Index, Mucosal Wave Grade and GRBAS (grade, roughness, breathiness, asthenia and strain).

Fibrocell said that though azficel-T did not meet these endpoints vs. placebo, no unexpected safety findings were reported and the treatment was well tolerated.

Posted In: BiotechNewsFDAGeneral
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