News

A Phase 2 clinical trial investigating the efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, revealed a clinically significant — although not statistically significant — improvement of skin sclerosis and lung function in patients with systemic sclerosis. The findings were published in The Lancet journal, in…

In the lung’s extracellular matrix (ECM) — observed in both cultured cells from systemic sclerosis patients and a mouse model — the protein netrin-1  was seen to regulate the accumulation of collagen-producing fibrocytes and promote pulmonary fibrosis. The study, “Netrin-1 Regulates Fibrocyte Accumulation in the Decellularized Fibrotic Sclerodermatous Lung Microenvironment and in Bleomycin-Induced Pulmonary Fibrosis,” published…

Cumberland Pharmaceuticals, Inc., recently announced the addition to its drug pipeline of Vasculan (ifetroban), an oral capsule that soon will enter clinical testing as a treatment of systemic sclerosis (SSc), or scleroderma. Vasculan is being evaluated for safety and efficacy in a randomized, double-blind and placebo-controlled Phase 2 clinical study in people with…

The Phase 3 STAR clinical trial from Cytori Therapeutics recently enrolled and treated its 60th patient — 75 percent of target patient enrollment. The FDA-approved Phase 3 STAR study is assessing the one-year safety and efficacy of the Celution Therapy ECCS-50 in the processing of an autologous graft consisting of adipose (fat) derived…

The U.S. Food and Drug Administration (FDA) has designated a potential gene therapy for localized scleroderma, FCX-013 by  Fibrocell Science, an orphan drug to help advance its development and testing. Fibroblasts, the basis of Fibrocell’s personalized cell and gene therapy platform, are the most common cell in skin and connective tissue, and responsible…

In a recent study, researchers identified advanced skin fibrosis at baseline as a predictor of likely regression — or disease improvement — in patients under standard of care measures in clinical trials, making this group the least ideal for inclusion in such trials. The study, “Prediction of improvement in skin fibrosis in diffuse cutaneous systemic…

Scleroderma patients with worsening interstitial lung disease would likely benefit from a treatment regimen consisting of cyclophosphamide pulses, followed by maintenance with the immunosuppressant mycophenolate mofetil (CellCept), researchers reported. The study highlighted the desperate need for better treatments, as slowing progression is the only option now available. Earlier studies have suggested that…

Researchers recently discovered a natural molecule, the M10 peptide, that can significantly decrease fibrosis in a mouse model of scleroderma. The study, “M10, a caspase cleavage product of the hepatocyte growth factor receptor, interacts with Smad2 and demonstrates antifibrotic properties in vitro and in vivo,” was published in the journal…

The U.S. Food and Drug Administration (FDA) approved Corbus Pharmaceuticals’ 12-month, open-label extension study of its ongoing Phase 2 clinical trial of Resunab for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). The extension study aims to offer all participants the option of receiving Resunab after they complete the 84-day, Phase 2,…

A research team with scientists from the University of Granada in Spain and the Spanish National Research Council (CSIC) has carried out the largest scleroderma study to date, creating a complete genetic map of the disease with the genetic analysis of more than 5,000 patients. Scleroderma, or systemic sclerosis, is a…