NASHVILLE, TN, July 22, 2021 — EV Biologics (OTC PINK:YECO) announced that it has signed a Letter of Intent (LOI) with Lonza Cell & Gene Therapy for Process Development and Gap Analysis for biomanufacturing of a novel therapeutic composition, comprising extracellular vesicles (EVs) and particles, as well as other secreted factors derived from selected stem/progenitor cells, such as mesenchymal stromal cells (MSCs). [Read more…]
Organicell™ Announces FDA Approval Of IND Application For The Use Of Zofin™ In COVID-19 Long Haulers
Miami, FL (July 21, 2021) — Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, for the treatment of ‘Prolonged COVID-19 Symptoms’ (“Long Haulers”). [Read more…]
Organicell Announces Positive Results Of Their Expanded Access Trial For The Treatment Of Mild To Moderate COVID-19 Using Zofin™
Miami, FL (June 15th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced the outcome of their expanded access (EA) intermediate size patient population trial (NCT04657406) which: [Read more…]
Direct Biologics Receives FDA Approval to Proceed with Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome
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Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome
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60-patient trial to be conducted nationally at ambulatory infusion sites
AUSTIN, Texas, June 9, 2021 – Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome. [Read more…]
Organicell To Present Results Of Zofin™ Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting
Miami, FL (May 25th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that the Company will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021. [Read more…]
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