Organicell Regenerative Medicine, 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 aims to demonstrate the safety of their 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.”
Source – AccessWire