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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 biopharmaceutical company specializing in the development of novel therapeutics to treat rare metabolic diseases. Our lead product candidate is INZ-701, an enzyme replacement therapy (ERT) in the early stages of clinical development for the potential treatment of patients with a variety of calcification disorders linked primarily to mutations in the ENPP1 and ABCC6 genes, or ENPP1 Deficiency and ABCC6 Deficiency respectively. We have demonstrated proof of concept with INZ-701 in both GACI and ARHR2 two phenotypes of ENPP1 Deficiency.
MEI Pharma (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. Our approach to building our pipeline is to license promising cancer agents and create value in programs through development and commercialization, or strategic partnerships, as appropriate. Our portfolio contains four clinical-stage drug candidates, including one candidate in an ongoing global registration trial and another candidate that is anticipated to advance into a registration trial this year. Our drug candidate pipeline includes: Pracinostat, an oral HDAC inhibitor that is in a Phase 3 pivotal study in combination with azacitidine for the treatment of acute myeloid leukemia. Pracinostat is also being evaluated in a clinical study in patients with myelodysplastic syndrome. Pracinostat is licensed to Helsinn Healthcare SA, a Swiss pharmaceutical corporation. ME-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (“PI3K”) delta. ME-401 is anticipated to progress into a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. Voruciclib, an orally administered and selective cyclin-dependent kinase (“CDK”) inhibitor differentiated by its potent in vitro inhibition of CDK9 in addition to CDK6, 4 and 1. Initiation of a Phase I dose-escalation study in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies is scheduled to being in the second calendar quarter of 2018. ME-344, a novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate, has demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study. In preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death. It is currently being evaluated in an investigator-initiated study in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in patients with HER2 negative breast cancer.
Nimbus Therapeutics is a biotechnology company headquartered in Cambridge, Massachusetts (USA).
BioMarker Strategies is a Baltimore, MD-based company in the Healthcare, Pharmaceuticals, and Biotech sector.