Clinical Trials 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 therapies and regenerative medicine, is pleased to announce that the long-running COVID clinical trial is officially active with enrollment.
“This announcement is a mandatory update as 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 Matt Sinnreich, interim CEO of Organicell.
He continued “Our team has been working with the FDA and its Institutional Review Board for six months on enrollment criteria to make these long COVID trials eligible. We have activated new clinical trial sites in Miami and Los Angeles. to reach a wider population of potential patients to help trials enroll quickly. Our clinical trial sites are now active, screening and recruiting patients!”
Organicell 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 in an FDA-approved IND Expanded Access Trial in moderate COVID, and 8 patients in an FDA-approved IND in moderate-to-severe COVID.
Sinnreich added “Organicell has published the results of patients treated with Zofin and the data is compelling. Our scientists observed the reduction in inflammation in key biomarkers (IL-6 and CRP) and the structural difference in the lungs after 30 days. The purpose of these lengthy COVID clinical trials is to prove that Zofin is the reason for these improvements.”
Zofin is a naturally occurring, cell-free, exosome-based therapeutic agent that we believe has natural anti-inflammatory properties. Organicell’s science team has worked with the CDC and accredited universities to further demonstrate the science to obtain Zofin in the hands of the masses.
Bloomberg, Reuters and even Nature.com have all shone the spotlight on the hundreds of millions and more of people affected by the long COVID. There is currently no solution to long COVID.
Bloomberg said in a November 1st article on long COVID that “at least 140 million people worldwide are suffering from long COVID and Harvard University economist David Cutler puts the total cost of long Covid in the United States at 3.7 trillion dollars. That equates to more than 80% of government spending on 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 set up the trials, but the company needs government support in the same way it helped accelerate development of the COVID vaccine. Organicell does not have the resources to spend million in lobbying, but that does not mean that the Society should be excluded from government programs.
Now that the midterm elections are over, it’s time to demand that 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 small business prove the effectiveness of their American-made treatment. With FDA approval, Zofin could have the potential to help so many people around the world.”
About Organicell Regenerative Medicines, Inc.
Organicell Regenerative Medicine, Inc. (OTCQB: OCEL) is a clinical-stage biopharmaceutical company primarily focused on the development of innovative biological therapies 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 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 involve assumptions, risks and uncertainties, and such expectations may prove to be incorrect. We remind you that actual results may vary significantly due to known and unknown risks and uncertainties, including, but not limited to: potential problems with our financial condition, competition, ability to retain personnel key, the safety, efficacy and acceptance of products, the commercial success of any new product or technology, the success of clinical programs, the ability to retain key customers, our inability to expand sales and distribution channels , laws or regulations affecting our operations, including pricing, reimbursement or access to products, the ability to protect our patents and other intellectual property both domestically and internationally, and other risks and known and unknown uncertainties, including risk factors discussed in the Company’s periodic reports that are filed with the SEC and available on the W eb of the SEC (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. The 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 expressly disclaims any obligation to update the information contained in this press release.
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