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Vital Therapies, Inc. is a biotherapeutic company focused on developing a cell-based system for the treatment of acute liver failure. Our product candidate, the ELAD® System, is a human cell-based, bio-artificial liver support system that operates outside the body, or extracorporeally, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The ELAD System incorporates our human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges, that are combined with single use customized disposable sets and an ancillary delivery system. Data from ELAD clinical studies has shown trends that may indicate a potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of our ongoing Phase III clinical trial program, over 145 subjects have received therapy with the ELAD System in seven clinical trials and through a compassionate use program, which we believe collectively suggests a promising therapeutic profile. In March 2013, we initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. We reached the midpoint in enrollment of this trial in April 2014, and anticipate the release of preliminary data in the first half of 2015. In addition, we are conducting a second Phase III randomized, controlled clinical trial, VTI-210, in 150 subjects with severe acute alcoholic hepatitis, or AAH, which is a subset of AILD, and expect to initiate enrollment of subjects later in 2014. In the second quarter of 2014, we began enrollment of a Phase II clinical trial of the ELAD System in subjects with either fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF. We anticipate the release of data from VTI-210 in 2016 and the Phase II component of VTI-212 in 2015 or 2016.
Orna Therapeutics is a biotechnology company dedicated to designing and delivering a new class of fully engineered circular RNA (oRNA) therapeutics with the potential to change the way we treat disease. Orna`s proprietary platform combines novel technology to create oRNAs that drive protein expression with validated and unique delivery solutions.
Corium International is a Grand Rapids, MI-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
We are a San Francisco Bay Area-based research stage biopharmaceutical company aiming to discover, develop and commercialize innovative therapeutics for the treatment of rare and age-related diseases. We are developing compounds to modulate molecular pathways that address the underlying causes of disease initiation and progression, such as oxidative, cellular and environmental stress.
PAREXEL International Corporation is the world`s leading innovator of biopharmaceutical services. We simplify our clients` journey of transforming scientific discoveries into new medical treatments for patients with high-quality Phase I-IV clinical research, regulatory, consulting and market access services. PAREXEL develops breakthrough innovations and solutions by leveraging its comprehensive therapeutic, technical and functional expertise, in more than 100 countries around the world.