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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…]

FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin(TM)

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Miami, FL (September 29, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted expanded access for an intermediate size population allowing its proprietary therapeutic, Zofin for the treatment of COVID-19. [Read more…]

FDA Grants RMAT to MultiStem Cell Therapy for Treatment of ARDS

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ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation

September 23, 2020; Cleveland — Athersys, a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for the acute respiratory distress syndrome (ARDS) program. [Read more…]

Organicell Phase I/II Clinical Trial Update

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Lead Therapeutic Candidate To Be Named Zofin(TM)

Miami, FL (August 18, 2020) — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that it has partnered with Alternative Research Associates, LLC and Larkin Hospital in Miami, FL to initiate a randomized, double-blinded, placebo-controlled phase I/II clinical trial against COVID-19 of its lead therapeutic candidate, which has been rebranded as Zofin. [Read more…]

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