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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.
Epizyme is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative personalized therapeutics for patients with genetically defined cancers. We systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found, and then design small molecule therapeutic product candidates to inhibit the oncogene. The clinical development plan for each of our therapeutic product candidates is directed towards patients with a particular genetically defined cancer. Our approach is part of a broader trend towards personalized therapeutics based on first identifying the underlying cause of a disease affecting specific patient populations, applying rational drug design tools to create a therapeutic to inhibit a molecular target in the identified disease pathway, and using a companion diagnostic to select the right patients for treatment. We have built a proprietary product platform that we use to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic. When Epizyme was founded, we recognized that the HMT class of enzymes might contain many potential oncogenes and presented the opportunity to discover, develop and commercialize multiple personalized therapeutics. We have prioritized 20 of the 96 HMTs as attractive targets for personalized therapeutics based on their oncogenic potential. Our two most advanced therapeutic product programs target the HMTs DOT1L (for the treatment of acute leukemias with genetic alterations of MLL) and EZH2 (for a genetically defined subtype of non-Hodgkin lymphoma and solid tumors including INI1-deficient tumors). We believe that our ongoing Phase 1 adult trial for EPZ-5676, targeting DOT1L, is the first clinical trial of an HMT inhibitor. In May 2014, we initiated a Phase 1b clinical trial for EPZ-5676 in pediatric patients with MLL-r leukemia, which is considered to be the last largely untreatable pediatric acute leukemia. We are also conducting a Phase 1/2 clinical trial of EPZ-6438, which is being developed for the treatment of non-Hodgkin lymphoma and solid tumors including INI1-deficient tumors such as synovial sarcoma and malignant rhabdoid tumors, or MRT. We were founded in 2007 and are led by a management team with extensive experience in the pharmaceutical industry. We have entered into therapeutic collaborations with Celgene, Eisai and GSK that have provided us with approximately $184 million in non-equity funding. As of June 30, 2014, we had $232.1 million in cash, cash equivalents and accounts receivables.
Novascreen Biosciences Corporation is a Hanover, MD-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
At Averitas Pharma, we strive to enable people with pain to live and feel more like their true selves. With patients at the forefront of every decision we make, we want more than to envision people not limited by their pain; we work every day with passion and determination to make it a reality. We are currently helping patients by offering the only FDA-approved, non-opioid, topical system for the treatment of neuropathic pain associated with postherpetic neuralgia (post-shingles nerve pain) and for neuropathic pain associated with diabetic peripheral neuropathy of the feet (diabetic nerve pain of the feet). We are proudly building on the 75-year legacy of Grünenthal, a global privately held healthcare company that has been working tirelessly toward a world free of pain by approaching pain as a disease in urgent need of a solution, rather than a mere symptom. We do it because we care. Most of us have either dealt with chronic pain or know someone who has, because it is a burden that far too many people around the world must bear. Our empathy for patients, and our shared sense of mission and purpose, are what inspires us to keep going. And our people are the key to our success. For more information, visit www.averitaspharma.com Community Guidelines: 1. We reserve the right to remove profanity, threatening or harassing content, promotional content and any personal information. 2. Due to FDA fair balance rules, we ask that you not mention any medicines or FDA-approved therapies by name or include links to third-party sites. 3. This site is not a forum for reporting side effects experienced while using an Averitas product. Physicians, other healthcare providers, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can visit www.fda.gov/medwatch or call 1-800-FDA-1088 For questions about our products call 1-877-900-6479. For more information, ask your healthcare provider or pharmacist.
Timken Radiology is a Winter Park, FL-based company in the Healthcare, Pharmaceuticals, and Biotech sector.