Clinical Trial Update
DAVIE, FL / ACCESSWIRE / November 15, 2022 / Organicell Regenerative Medicine, Inc. (OTCQB:OCEL), a clinical-stage biopharmaceutical company focused on the development of innovative biological therapeutics and regenerative medicine, is pleased to announce that Mayo Clinic will be the site for clinical trials on Chronic Obstructive Pulmonary Disease (COPD).
Mayo Clinic in Phoenix, Arizona will be the clinical trial site for Organicell's Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).
Organicell completed the site activation and is ready to begin enrollments.
Organicell aims to demonstrate the safety of Organicell's lead extracellular vesicle biologic, Zofin, while concurrently investigating the drug's potential long-term benefits for improved pulmonary function and quality of life measures in chronically ill COPD patients.
Extracellular vesicle and exosome-based drugs, like Zofin, are becoming increasingly popular due to the number of anti-inflammatory and immune-modulatory effects. In chronic illnesses where inflammation is high, such as COPD, extracellular vesicles and exosomes offer an innovative solution for patients with unmet medical needs.
Organicell's Chief Medical Officer, Dr. George Shapiro said, "The association between COPD patients and Covid-19 is now clear. Based on the results I have seen in the numerous Emergency Investigative New Drug treatments we've conducted; this COPD trial was a natural progression of Organicell's science."
COPD including emphysema and chronic bronchitis - a common airway disease that affects approximately 10% of individuals over 45 years of age, is a concern in patients who are infected with the Sars-Cov-2 viruses causing covid-19 disease.
It is well known that COPD patients are prone to viral exacerbations and current evidence shows that COPD patients have increased pulmonary expression of ACE2, the SARS-CoV-2 receptor, providing a mechanism by which COPD patients may be more susceptible to COVID-19. COPD patients also demonstrate features of endothelial cell dysfunction and increased coagulopathy, which may predispose to increased risk of worse outcomes from COVID-19.
Dr. George Shapiro added: "COPD patients who have Covid-19 are two and half times more likely to experience ICU admissions, invasive mechanical ventilation, or death.
Clinical outcomes including requirement for mechanical ventilation and mortality appear to be worse in COPD patients resulting in a three-fold greater risk of mortality. If people with this underlying condition do get COVID-19, they are at high risk for complications and poorer outcomes.
There is likely another round of COVID bound to hit this flu season. The timing of this trial couldn't be more relevant to those suffering with COPD."
About Organicell Regenerative Medicines, Inc.
Organicell Regenerative Medicine, Inc. (OTCQB:OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and the provision of other related services. The Company's proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. To learn more, please visit https://organicell.com/.
Certain statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the "Securities Act"), the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as "will", "believes", "expects", "potential", or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally, and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.
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SOURCE: Organicell Regenerative Medicine, Inc.