June 30, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Exton, Pennsylvania - Fibrocell Science announced today that it is closing down its azficel-T operations and cutting 24 jobs as a result, primarily in manufacturing and quality operations.
On June 8, the company announced that its Phase II clinical trial of azficel-T to treat vocal cord scarring that resulted in chronic or severe dysphonia, failed to meet its primary endpoints. Endpoints assessed at four months included Voice Handicap Index, Mucosal Wave Grade and GRBAS (grade, roughness, breathiness, asthenia and strain).
“We are disappointed that azficel-T did not demonstrate the anticipated benefits for patients in this Phase II clinical trial,” said David Pernock, chairman and chief executive officer of Fibrocell in a statement. “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 plans to refocus its efforts on developing FCS-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), and FCX-013 for the treatment of linear scleroderma, as well as its genetically-modified fibroblasts to treat arthritis and related conditions.
Fibrocell is also actively looking for someone to buy azficel-T and is going to wind down its azficel-T manufacturing and related operations in Exton, Pennsylvania. As a result, the company hopes to slow its cash burn for the rest of the year, decreasing to about $1.6 million compared to its previous year-to-date monthly average of $2.2 million. The company also indicates that resources that support its gene therapy programs are unaffected.
“We believe our innovative gene therapy programs have the potential to be transformative for patients suffering from debilitating genetic diseases that have few treatment options,” Pernock said in a statement. “We are uniquely positioned to leverage our versatile autologous fibroblast technology with our collaborator Intrexon’s genetic engineering expertise to be a leader in developing cell-based gene therapies. Earlier this month, we initiated adult patient recruitment in our Phase I/II clinical trial for FCX-007 and expect to enroll the first subject shortly.”
Fibrocell has been on something of a slide recently. Shares traded on Aug. 5, 2015 for $7.48, dropped to $3.62 on Oct. 6, rose to $5.99 on Nov. 27, then dropped to $2.12 on Feb. 11, 2016. Shares recovered slightly on April 22, 2016 to $3.32. They are currently trading for $1.10 per share.
Jill Kemp, writing for News Oracle on Tuesday, said, “The High price target of the company’s Share is at $12 based on the calculations and analysis of four brokers. According to the analysts, the company has the Low Price target of $1.50 whereas the Mean Target is estimated by the brokers as $5.”
Two analysts gave Fibrocell a “strong buy,” one gave it a “buy,” and one assigned it a “hold.”
