Organicell Provides Phase 1/2 Clinical Trial Update
Organicell Regenerative Medicine, Inc. recently announced it has partnered with Alternative Research Associates, LLC and Larkin Hospital in Miami, FL, to initiate a randomized, double-blinded, placebo-controlled Phase 1/2 clinical trial against COVID-19 of its lead therapeutic candidate, which has been rebranded as Zofin.
To date, a total of five patients have been treated with Zofin under the US FDA emergency Investigational New Drug (eIND) Program. Three of these COVID-19 patients were hospitalized in critical condition and, following treatment, regained complete recovery of lung and renal function. The other two patients were treated as outpatients and both have shown significant improvements in all symptoms and will continue to be monitored.
The objective of the FDA Phase 1/2 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 2 weeks.
In addition to the rebranding of its therapeutic candidate, Organicell will be unveiling a new corporate logo, tagline and website. The new brand reflects the company’s renewed focus on building and advancing a portfolio of biologics.
Albert Mitrani, Chief Executive Officer of Organicell, stated “Our team and stakeholders have worked vigilantly to make 2020 a milestone year at Organicell. We are pleased to partner with Alternative Research Associates and Larkin Hospital to advance this important clinical study to evaluate moderate to severe patients with COVID-19.”
Dr. Maria Ines Mitrani, Chief Science Officer at Organicell stated “We look forward to working with our partners at Larkin Community Hospital to evaluate the treatment of Zofin in moderate to severe COVID-19 patients.”
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South FL, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. For more information, visit https://organicell.com/.
Larkin Community Hospital is an integrated healthcare delivery system accredited by the Joint Commission with locations in South Miami, Hialeah and Hollywood, Florida. Our network of acute care hospitals provides a complete continuum of healthcare services, including a full range of inpatient and outpatient services, home health agencies, Skilled Nursing facilities, Rehab centers and Assisted Living facilities in Miami-Dade and Broward County. For more information, visit http://larkinhospital.com/.
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