Fibrocell Science Inc (NASDAQ:FCSC) has reported that its Phase II trials for a vocal cord scarring treatment called azficel-T did not go as the firm has expected.
The firm stated that the trials did not meet the primary endpoints during phase II trials. Fibrocell’s CEO and Chairman David Pernock stated that the company was disappointed with the drug because it did not achieve the benefits that the company had predicted for the patients during the clinical trials. The CEO further added that the firm will continue to analyze the data from the tests so that it can get a deeper understanding of the results of the study. They will also follow through with the 12-month primary end-point.
The CEO also stated that the firm conducted the trials in a good manner and they addressed all the objectives that were designed for the evaluation. Pernock also noted that Fibrocell was thankful for the support offered by investors as well as their patience. He also expressed gratitude to all who participated in the trials. The phase II trial was a randomized, double-blind and it was also controlled through a placebo. The test was also designed to analyze the safety and efficiency of the azficel-T drug in patients suffering from chronic dysphonia. The latter is caused by atrophy or vocal cord scarring.
The primary end points were analyzed four months into the trials after the final treatment on three different levels which include Mucosal Wave Grade, Voice Handicap Index and GRBAS (grade, roughness, breathiness, asthenia and strain). Though the drug did not achieve the expected results, no safety incidents were reported and the test subjects tolerated the treatment. Fibrocell specializes in autologous cell and gene therapy. One of the firm’s objectives is to carry out research for the development of breakthrough treatments for skin diseases, joints and connective tissue. The firm uses genetically altered fibroblasts in its research. Fibrocell also announced that it will divert its efforts to the development of FCX-007 which is a treatment to address recessive dystrophic epidermolysis bullosa.