Golden, Colorado-April 6, 2021 — Vitro Biopharma, Inc. announced receipt of FDA authorization and clearance to enroll patients in its phase I-IIa, randomized, double-blinded, placebo controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells® in adults with COVID-19. Our Investigational New Drug (IND) application will investigate the clinical effects of AlloRx Stem Cells® by studying safety and efficacy in patients with moderate to severe COVID-19. [Read more…]
Noninvasive cellular and acellular therapies will lead to life-extending medicines and treatments, including post-COVID anti-inflammation therapy. A new partnership between the world’s top university for biotech business incubation and Neobiosis, a global expert in regenerative medicine, may fuel a healthcare revolution.
Alachua, FLA., January 19, 2021 – The inflammation COVID-19 patients suffer during and post-COVID-19 infection (AKA “Post-COVID Syndrome”) will be one of many focuses of a new Research & Development laboratory recently launched at the University of Florida Sid Martin Innovate Biotechnology Institute, the world-recognized leader in biotechnology incubation(1). Neobiosis, which produces regenerative tissues, cells and extracellular vesicles for research and clinical trials to help the body heal itself—without surgery—will operate the laboratory at the biotech center, located in Alachua, Fla. [Read more…]
Encouraging animal model efficacy data has been published in Journal of Ethnopharmacology
Clinical trial of 100 patients diagnosed with COVID-19 to begin soon in India
TADIOS found to have anti-inflammatory, anti-oxidative activities and therapeutic effects in acute lung injury animal model
January 14, 2021 – Helixmith Co., Ltd. has announced that TADIOS (HX110), a respiratory treatment developed by the company, showed lung damage-suppressing capability in an acute lung injury mouse model. The results have been published in the Journal of Ethnopharmacology. Helixmith plans to conduct a clinical trial in India to assess if TADIOS can be used as a COVID-19 treatment. Helixmith has signed an agreement with a contract research organization (CRO) that has extensive experience and capacities in the conduct of clinical trials in India. The clinical trial will be conducted in accordance with the regulations of the Ministry of AYUSH, India’s traditional medicine regulatory body, and will begin in February with 100 subjects. [Read more…]
Sentien Biotechnologies Does First Subject in a Phase 1/2 Trial of its Ex Vivo MSC Therapy Against Severe COVID-19 at the University of New Mexico Hospital.
LEXINGTON, MA, NOVEMBER 23, 2020 — Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, announced that the first subject has been enrolled in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19 at the University of New Mexico (UNM) Hospital. SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT). [Read more…]
Novartis enters into exclusive worldwide license with Mesoblast to develop, commercialize and manufacture remestemcel-L for treatment of acute respiratory distress syndrome (ARDS) and other indications
Addition of remestemcel-L could expand Novartis respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential
Deal includes $50 million upfront cash payment and equity/share subscription, plus performance-based milestones and royalties for access to a cell-therapy based platform with worldwide rights to a range of potential indications
Basel, November 19, 2020 — Novartis announced that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation.1,2
As the potential first ARDS therapy, remestemcel-L will use mesenchymal stromal cells (MSCs), a cell-based platform technology, to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase III study.3 Novartis intends to initiate a Phase III study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current study. [Read more…]