Organicell Activates COPD Trial at Mayo
Clinic
Clinical
Trial Update
DAVIE, FL
-- November 15, 2022 --
InvestorsHub NewsWire -- 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/.
Forward-Looking Statements
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.
Investor Relations and Media Relations
Contact
Organicell Investor Relations
1-888-963-7881 Ext.701
IR@organicell.com