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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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
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: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Beauty Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 14, 2022
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
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 EnablingProduct Type: Large molecule
Recipient: Regenerative Care Network
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 20, 2020
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
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 IIProduct Type: Large molecule
Recipient: Alternative Research Associates
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 18, 2020
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
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 IIProduct 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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