Zofin (Organicell Flow) / Organicell - LARVOL DELTA

Zofin (Organicell Flow) for Patients With COVID-19 (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Organicell Regenerative Medicine | Active, not recruiting ➔ Completed

Trial completion • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

Zofin to Treat COVID-19 Long Haulers (clinicaltrials.gov) - P1/2 | N=18 | Completed | Sponsor: Organicell Regenerative Medicine | Recruiting ➔ Completed | N=30 ➔ 18 | Trial completion date: Jul 2024 ➔ Oct 2023 | Trial primary completion date: Apr 2024 ➔ Oct 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IL6 • TNFA

Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1/2 | N=20 | Suspended | Sponsor: Organicell Regenerative Medicine | Recruiting ➔ Suspended

Trial suspension • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Organicell Regenerative Medicine

New P1/2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Zofin to Treat COVID-19 Long Haulers (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Organicell Regenerative Medicine | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Sep 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IL6 • TNFA

Zofin (Organicell Flow) for Patients With COVID-19 (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: Organicell Regenerative Medicine | Trial completion date: Jun 2022 ➔ Aug 2023 | Trial primary completion date: May 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

Zofin to Treat COVID-19 Long Haulers (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Organicell Regenerative Medicine | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2023 ➔ Dec 2023

Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IL6 • TNFA

Zofin to Treat COVID-19 Long Haulers (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Organicell Regenerative Medicine

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • CRP • IL6 • TNFA

Zofin (Organicell Flow) for Patients With COVID-19 (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: Organicell Regenerative Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2021 ➔ Jun 2022 | Trial primary completion date: Jun 2021 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • CRP • IL6 • TNFA

Proof-of-Concept Trial of an Amniotic Fluid-derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection. (PubMed, Biomater Biosyst) - "Zofin is an investigational, acellular biologic derived from full-term perinatal amniotic fluid that contains extracellular vesicles...Inflammatory biomarkers (CRP, IL-6, TNF- ) and absolute lymphocyte counts improved throughout the study period. Findings from a proof-of-concept, expanded access trial for COVID-19 patients prove the acellular biologic is safe and potentially effective to prevent disease progression in a high-risk COVID-19 population with mild-to-moderate symptoms."

Clinical • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • IL6

Organicell Announces Positive Results of Their Expanded Access Trial for the Treatment of Mild to Moderate COVID-19 Using Zofin (Businesswire) - P=NA, N=NA; "Organicell Regenerative Medicine, Inc....announced the outcome of their expanded access (EA) intermediate size patient population trial...Met endpoints for safety and efficacy in patients with mild to moderate COVID-19; Mitigated mild and moderate symptoms; Improved pulmonary opacities detected in chest X-rays; Improved inflammatory biomarkers....The administration of ZofinTM was well tolerated in all enrolled subjects, with no adverse events....Organicell will immediately submit this data to the FDA for a requested amendment to their approved IND [NCT04384445] to perform a placebo-controlled Phase 2 clinical trial to confirm safety and efficacy in a randomized fashion."

Biomarker • Clinical data • Infectious Disease • Novel Coronavirus Disease

Organicell To Present Results Of Zofin Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting (Businesswire) - "Organicell Regenerative Medicine, Inc....will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021....This presentation comes as a follow up to recently published case report studies demonstrating the investigation of Zofin™ in three severely ill COVID-19 patients. In these studies, results found the administration of Zofin™ to be associated with decreased levels of inflammatory biomarkers, such as CRP and IL6."

Clinical data • Infectious Disease • Novel Coronavirus Disease

Organicell Receives Approval in Pakistan for the Use of Zofin for Compassionate Grounds for COVID-19 (Businesswire) - "Organicell Regenerative Medicine, Inc....announced its Zofin™ therapy has been approved by Pakistani regulators to be used for a COVID-19 patient on compassionate grounds. The Drug Regulatory Authority of Pakistan has approved Zofin™ for use with a named patient on compassionate grounds following the patient’s COVID-19 diagnosis and admittance to an intensive care unit for treatment on a ventilator....Organicell has received further authorization to begin a broader trial of Zofin™ with up to 60 additional patients suffering from moderate to severe COVID. The Company has already shared data with regulatory authorities in the country in support of this effort and hopes to come to an arrangement and commence this trial in the near future."

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease

Organicell Announces Positive Results of Initial COVID-19 Zofin Patient Trial in India and Trial Expansion (Businesswire) - P=NA, N=75; "Organicell Regenerative Medicine...announced positive results for the first ten COVID-19 patients treated with Zofin™ in India....The initial ten trial participants were hospitalized patients and were treated...and all patients have recovered from their symptoms and have since been discharged from the hospital. Based on the initial results of this trial, the trial will be expanded to an additional sixty-five patients with moderate to severe COVID-19, who will be treated at these hospitals over the next several weeks, with treatments expected to be completed by the end of June 2021. If the results of the expanded trial are similarly positive, Organicell and CWI India, intend to file with the ICMR (Indian Council for Medical Research) for Emergency Use Approval to use Zofin™ in India as a therapeutic for treating COVID-19."

Clinical data • Infectious Disease • Novel Coronavirus Disease

Organicell Completes Enrollment for its Expanded Access Trial to Treat COVID-19 Patients with Zofin (Businesswire) - "...the company has completed enrollment for its U.S. Food and Drug Administration (FDA) granted expanded access trial for Zofin for the treatment of COVID-19....Analysis of initial trial data will begin in approximately seventy-five days, and the trial will conclude ninety-days after the last patient is dosed, which is expected sometime in the third quarter of this year....'We are excited that the enrollment of patients in this trial is complete and we look forward to analyzing the data next quarter,'..."

Clinical data • Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease

‘Frontiers in Medicine’ Publishes Organicell’s Case Report Demonstrating the Use of Zofin in the Treatment of COVID-19 Patients (Businesswire) - "Organicell Regenerative Medicine, Inc....today announced the publication of a peer-reviewed case report analyzing the clinical outcomes of Zofin treatment in three critically ill patients suffering from severe, multi-organ complications induced by COVID-19 infection....The peer-reviewed article demonstrates the first use of an amniotic fluid-derived extracellular vesicles biologic as a safe and potentially efficacious therapeutic treatment for respiratory failure induced by COVID-19 infection....Zofin was administered to patients concurrently with ongoing medical care and were monitored for 28-days post-therapy."

Clinical data • Infectious Disease • Novel Coronavirus Disease

Organicell Announces FDA Approval Of IND Application For The Use Of Zofin In The Treatment Of Osteoarthritis (Businesswire) - "Organicell Regenerative Medicine...announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, in the treatment of knee osteoarthritis....This approved trial design, which will begin in the second quarter of this year, will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of Zofin™ for patients suffering with knee osteoarthritis...'We are excited to initiate this FDA approved clinical trial and to further explore the potential of Zofin™ in battling this disease.'"

IND • CNS Disorders • Osteoarthritis • Pain

Zofin (Organicell Flow) for Patients With COVID-19 (clinicaltrials.gov) - P1/2; N=20; Recruiting; Sponsor: Organicell Regenerative Medicine; Trial completion date: Dec 2020 ➔ Jul 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IL6 • PCR • TNFA

Organicell Announces FDA Approval of IND Application for the Use of Zofin in the Treatment of Chronic Obstructive Pulmonary Disease (COPD) (Businesswire) - "Organicell Regenerative Medicine, Inc....announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (COPD). This approved trial design will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of intravenous infusion (IV) of Zofin™ for the treatment of COPD....'We are excited to initiate this FDA approved clinical trial and to further explore the potential of Zofin™ in battling this disease.'"

IND • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Organicell Regenerative Medicine and Its Investigational Therapeutic Zofin Featured in Two National Publications Examining Potential Therapies for COVID-19 Long-Haulers (Businesswire) - "Organicell Regenerative Medicine, Inc....announced that the Company and its therapeutic drug Zofin™ were recently featured in articles...which examined potential therapies for COVID-19 long-haulers....Zofin™ is currently being tested in a phase I/II randomized, double blinded, placebo trial...It is the Company’s intention, subject to favorable results, careful data analysis, discussion with and approvals from the FDA, to begin a Phase IIb confirmatory trial as early as the first quarter of 2021."

New P2b trial • Review • Infectious Disease • Novel Coronavirus Disease

Expanded Access to ZofinTM (OrganicellTM Flow) for Patients With COVID-19 (clinicaltrials.gov) - P; N=N/A; Available; Sponsor: Organicell Regenerative Medicine

Clinical • New trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Organicell Announces Additional Site for Phase I/II Clinical Trial of Zofin for Treatment of COVID-19 (Businesswire) - "Organicell Regenerative Medicine, Inc....announced today that it is now enrolling patients at an additional site, Larkin Hospital North located in Hialeah, Florida for its Phase I/I clinical trial for the use of its Zofin™ therapeutic in treatment of COVID-19....The study will be enrolling 20 participants. As of November 17, 2020, several patients have already begun treatment at Larkin Hospital South, located in South Miami, Florida....'To date, we have successfully enrolled several patients who have begun treatment in this trial, with no reported serious adverse events.'"

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

Organicell Provides Update on Its COVID-19 Clinical Trial Using Zofin (Businesswire) - "The Company’s current Phase I/II clinical trial...is a randomized, double-blinded, placebo-controlled phase I/II trial designed to investigate its proprietary therapeutic, Zofin™....To date, several patients have been enrolled, dosed and treated at Larkin Hospital in Miami, Florida. Organicell expects to finish enrollment and complete the trial by December 31, 2020. It is the Company’s intention...to begin a Phase IIb confirmatory trial as early as the first quarter of 2021....Company is negotiating an agreement with a nationally known CRO to support the needed services related to running its clinical trials. The Company expects this agreement to be finalized in the coming days."

New P2b trial • Trial completion date • Trial status • Infectious Disease • Novel Coronavirus Disease

First Reported “Long-Hauler” Post COVID-19 Patient Treated with Zofin Produces Excellent Preliminary Results (Businesswire) - "Organicell Regenerative Medicine, Inc....announced that the U.S. Food and Drug Administration (FDA) granted emergency, expanded access approval to treat one 'long-hauler' patient on August 1, 2020, and two additional patient approvals on August 17, 2020....After receiving three doses of Zofin, he is now free of post-COVID-19 complications and plans to return to work on September 1, 2020....Three severely ill COVID-19 patients were treated with Zofrin at Landmark Hospital...with all patients reporting excellent results....Organicell is preparing to submit additional phase I/II INDs to treat COVID-19 long-haulers."

Clinical data • Infectious Disease • Novel Coronavirus Disease

Three New COVID-19 Patients Treated with Zofin Report Improvement (Businesswire) - "Organicell Regenerative Medicine, Inc....announced that the U.S. Food and Drug Administration (FDA) granted emergency, expanded access approval to treat two mild to moderate COVID-19 patients and one 'Long Hauler' post COVID-19 patient....'The six outpatients with different stages of COVID-19 were treated with Zofin under an emergency investigational new drug expanded access program, with physicians for all six patients reporting significant improvement'....'Organicell will commence patient enrollment this week in a Phase I/II clinical trial to evaluate the treatment of Zofin in moderate to severe COVID-19 patients at Larkin Community Hospital in Miami.'"

Clinical data • Enrollment status • Infectious Disease • Novel Coronavirus Disease