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Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.
BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person`s own) cultured mesenchymal stem cells collected from the patient`s bone marrow. We intend that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The BRTX-100 production process involves collecting a patient`s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient`s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received clearance from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. • Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines. Our six international locations offer comprehensive CDMO and BioAnalytical CRO services to a wide range of clients worldwide. We recognize the intricate challenges associated with advancing a promising molecule from the laboratory to the patient. Our multidisciplinary team is eager to collaborate with you throughout your development process, utilizing specialized technologies to optimize formulation and manufacturing. We possess extensive expertise in spray drying, hot melt extrusion, and lipid-based formulations that enhance bioavailability and solubility. Additionally, our capabilities include polymeric, metal, and lipid nanoparticles for advanced drug delivery applications, as well as high-potency and controlled substance handling for highly specialized therapeutics. At Ardena, all work adheres to the appropriate regulatory standards as you progress through the clinical development pathway. Please contact us to further discuss your clinical and scientific objectives and explore how we can work together.
Selventa is a Cambridge, MA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.