Clinical Trial Update
MIAMI, FL / ACCESSWIRE / November 17, 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 the long COVID Clinical Trial is officially active with enrollment.
"This announcement is an obligatory update because there has been a change in the status of our clinical trials, they are now active and enrolled with patients… but I want this news to be a call to action!" said Organicell's acting CEO Matt Sinnreich.
He continued "Our team has been working with the FDA and its Institutional Review Board for the last six months on the enrollment criteria to make these long COVID trials enrollable. We have activated new clinical trial sites in Miami and Los Angeles to reach a larger population of potential patients to help the trials fully enroll quickly. Our clinical trial sites are now active, screening, and enrolling patients!"
Organicell has treated 18 people for COVID with Zofin under the guidance of the FDA's Emergency Investigational New Drug (eIND) program. The Company has also treated 10 patients under an FDA approved IND expanded access trial on Moderate COVID, and 8 patients under an FDA approved IND for Moderate to Severe COVID.
Sinnreich added "Organicell has published the results of the patients treated with Zofin and the data is compelling. Our scientists observed the reduction of inflammation in key biomarkers (IL-6 and CRP) and the structural difference in the lungs after 30 days. The purpose of these long COVID clinical trials is to prove that Zofin is the reason for these improvements."
Zofin is a naturally derived, acellular, exosome-based therapeutic which we believe has naturally occurring anti-inflammatory properties. Organicell's science team has been working with the CDC and accredited Universities to further demonstrate the science to get Zofin into the hands of the masses.
Bloomberg, Reuters, even Nature.com have all shined a spotlight on the hundred million plus people affected by long COVID. There are currently no solutions to long COVID.
Bloomberg stated in a November 1st article on long COVID that "at least 140 million people worldwide are suffering with long COVID and Harvard University economist David Cutler puts the total cost of long Covid in the US at $3.7 trillion. That's equal to more than 80% of government outlays for the pandemic through the end of July. And scientists still don't know what causes it, how many people it affects, or how to prevent and treat it."
Sinnreich concluded, "Organicell has the trials set up, but the Company needs the support of the government in the same way they helped expedite the COVID vaccine development. Organicell does not have the resources to spend millions on lobbying, but that does not mean that the Company should be excluded from government programs.
Now that the midterm elections are over, it is time we demand our politicians do something to help us! This virus is not going away. Our goal is to get the attention of the right people in government to help a smaller company prove the efficacy of its American-made therapeutic. With FDA approval, Zofin could have the potential to help so many people worldwide."
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.
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SOURCE: Organicell Regenerative Medicine, Inc.