GAINESVILLE, Fla., – Neobiosis, is a leading research and manufacturing biotechnology company focused on pioneering the development of novel therapeutics from perinatal tissues as a new class of medicines. Today, Neobiosis announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ViXome™, its drug for the treatment of ‘Post COVID Syndrome (AKA “Long Haul COVID Syndrome”). [Read more…]
StemCyte to Supply Raw Materials for Immune Cell Therapies Derived from Umbilical Cord Blood
BALDWIN PARK, Calif., — As international demand for starting substances for use in cell therapy emerges, California-based regenerative therapeutics company StemCyte announced it has signed a cooperation agreement with a leading US cell therapy company that is developing allogeneic genetically modified CAR-NK cells using umbilical cord blood. StemCyte has agreed to supply the necessary cellular raw materials for allogeneic cell therapy product development worldwide. [Read more…]
Axol Bioscience and StrataStem to Deliver iPSC-Derived ‘Clinical Trial in a Dish’ for Alzheimer’s Disease
Together, an extensive panel of consented patient samples and iPSC technology will advance AD drug development and patient stratification.
CAMBRIDGE, England & EDINBURGH, Scotland — Axol Bioscience Ltd. (Axol), a leading pluripotent stem cell technology provider for drug discovery has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples. Harnessing its stem cell expertise, Axol will reprogram these patient samples into induced Pluripotent Stem Cells (iPSCs) that can then be differentiated into a wide range of brain cells, including neurons and neuroinflammatory cells. Grown in vitro, these cells can provide patient specific human brain models from a large cohort of AD patients – to create a ‘clinical trial in a dish’. [Read more…]
IPS HEART Advances Development of ISX9-CPC, a Drug Candidate that Reprograms iPSCs into New, Functional Heart Muscle
HOUSTON–IPS HEART, a privately held cell therapy company advancing its stem cell platform to develop new skeletal muscle and cardiac muscle generation treatments for Duchenne muscular dystrophy (a rare disease) and heart failure, today announced that the U.S. Food and Drug Administration (FDA) awarded a third Rare Pediatric Drug Designation (RPDD) for its product candidate, ISX9-CPC, for treatment of cardiomyopathy associated with Danon disease. ISX9-CPC stem cell therapeutic candidate is designed to create new functional human heart muscle along with reducing cardiac fibrosis. [Read more…]
Direct Biologics Announces Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Clinical Trial
AUSTIN, Texas– Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells (BM-MSCs) to address multiple disease indications, announces favorable safety data and significant efficacy results from its Phase 2 clinical trial (NCT04493242) of ExoFlo™ in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS). [Read more…]
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