Seqens Seqens

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[{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell Announces FDA Approval of IND Application for the Treatment of SARS Due to COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Undisclosed","date":"May 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell Reports Positive Results from Compassionate Use of Organicell Flow in Severely Ill COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Organicell Regenerative Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Organicell Partnered With Alternative Research Associates","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Organicell Expanded Access To Treat COVID-19 Patients With ZofinTM","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Regenerative Care Network","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Organicell Partners with Regenerative Care Network to Study Potential Therapeutic Benefits of Zofin\u2122 for Patients with Heart Failure","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell's Zofin\u2122 Featured in Two National Publications Examining Potential Therapies for COVID-19 Long-Haulers","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell Completes Enrollment for its Expanded Access Trial to Treat COVID-19 Patients with Zofin\u2122","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell Receives Approval in Pakistan for the Use of Zofin\u2122 for Compassionate Grounds for COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Beauty Health","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BeautyHealth\u2019s Hydrafacial Announces Partnership With Organicell To Develop Breakthrough Exosome Booster","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Undisclosed"},{"orgOrder":0,"company":"Organicell Regenerative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organicell Starts Enrolling Long COVID Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"}]

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            Development Status

            Details:

            Zofin is an acellular, minimally manipulated product, derived from human amniotic fluid (HAF). This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from amniotic stem and epithelial cells.

            Lead Product(s): Human Amniotic Fluid

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2022

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            Details:

            Exosomes are small membrane vesicles, which are among the most productive and conducive to wound healing and countering inflammation. The benefits will help treat the skin and address signs of aging when delivered as a booster through Hydrafacial’s exceptional delivery system.

            Lead Product(s): Exosome Based Therapeutic

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Beauty Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 14, 2022

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            Zofin™ is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin™ for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

            Lead Product(s): Amniotic fluid derived microRNAs

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2021

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            Details:

            The expanded access protocol provided access to the investigational product, Zofin, for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19 infection, or who are judged by a healthcare provider to be at high risk.

            Lead Product(s): Zofin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 22, 2021

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            Details:

            Zofin™ is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent.

            Lead Product(s): Zofin

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 29, 2020

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            Details:

            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.

            Lead Product(s): Zofin

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Zofin

            Highest Development Status: IND Enabling Product Type: Large molecule

            Recipient: Regenerative Care Network

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 20, 2020

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            Details:

            Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDA’s approved expanded access program.

            Lead Product(s): Zofin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

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            Details:

            The objective of the FDA phase I/II study is to investigate the safety and potential efficacy of perinatal sourced components for COVID-19. The study will enroll 20 patients and is expected to commence within the next two weeks.

            Lead Product(s): Zofin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Recipient: Alternative Research Associates

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 18, 2020

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            Details:

            Treatment with Organicell Flow resulted in a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data.

            Lead Product(s): Organicell Flow

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2020

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            Details:

            This trial will be the first randomized, double-blinded, placebo-controlled, phase I/II multi-center trial investigating the safety and efficacy of amniotic fluid sourced components for COVID-19.

            Lead Product(s): Organicell Flow

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 05, 2020

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