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Sentien Biotechnologies Does First Subject with Ex Vivo MSC Therapy Against COVID-19

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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 Snags Exclusive Rights from Mesoblast for MSC Therapy Against COVID-Induced ARDS

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  • 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…]

Invitrx Therapeutics to Co-Sponsor Baylx, Inc’s US FDA Approved Umbilical Cord Tissue Mesenchymal Stem Cells Product for COVID-19

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Irvine, CA., November, 23 2020 — Invitrx Therapeutics has formally signed a joint venture agreement with Baylx, Inc. (Baylx), to co-sponsor Baylx’s FDA approved Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19. [Read more…]

Organicell Provides Update on Its COVID-19 Clinical Trial Using Zofin™

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  • Anticipates Phase I/II trial completion by end of year

  • Anticipates Phase IIb trial to begin in Q1 2021

  • Seeks to retain a global contract research organization (“CRO”)

Miami, FL (November 12, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today provided an update on its Phase I/II clinical trial for treatment of COVID-19 using Organicell’s proprietary therapeutic, Zofin™, which is currently underway as well as an update on its expanded access protocol for outpatients with COVID-19. [Read more…]

Organicell Partners with Regenerative Care Network to Study Potential Therapeutic Benefits of Zofin™ for Patients with Heart Failure

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MIAMI, Oct. 20, 2020 — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that it has recently entered into an agreement with Regenerative Care Network (“RCN”). Organicell and RCN plan to collaborate on clinical research projects investigating use of Organicell’s lead therapeutic, Zofin™, as a novel therapeutic for heart failure with preserved ejection fraction, known as HFpEF. [Read more…]

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