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…
Antegrin Therapeutics announced that it has acquired the licenses to a series of drugs targeting integrins. With the addition of these drugs, Antegrin hopes to be one step closer to the commercialization of anti-integrin therapies for the treatment of scleroderma and other fibrotic diseases. Integrins are cell surface receptors attaching…
Bosentan and other drugs belonging to the group of endothelin-1 receptor blockers showed promise in preclinical fibrosis models, but delivered disappointing results in clinical trials. Now, a real-life observational study adds to the setback, with this group of drugs showing no effect on skin fibrosis in scleroderma. Endothelin-1 receptor blockers…
In a new article, a multidisciplinary team of international researchers summarized key points and deliberations regarding basic, clinical, and novel therapeutic research made at a World Scleroderma Foundation three-day meeting that gathered senior and junior investigators across research areas, as well as a patient spokesperson. The report’s main goals were to…
Cytori Therapeutics has enrolled and treated its 40th patient with scleroderma in the Phase 3 STAR clinical trial for ECCS-50, marking 50 percent of target enrollment. The company also said a data monitoring committee has reviewed the safety results from the first 20 patients treated in the trial and has recommended it…
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