Complete elimination of viral load in 100% of patients at day 7 vs 6% in placebo (p=.001)
Complete elimination of most symptoms by day 7
Galectin antagonist acts as an entry inhibitor for use in treatment of COVID-19
BOSTON, MASSACHUSETTS, June 27, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that the journal “Vaccines” released a peer-reviewed article, “An Oral Galectin Inhibitor in COVID-19 – A Phase 2 Randomized Controlled Trial”, which contains top-line safety and efficacy results of the Company’s randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered. The endpoint was a statistically significant reduction in viral load measured by the number of patients reaching a below threshold PCR value (Ct value ≥ 29) by day 7. Additionally, most of the symptoms completely disappeared in the group receiving the drug whereas the placebo group had 41.18% of patients that continued to experience chills, 29.41% that had a feverish sensation, and 35.29% that had a cough on day 7. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value =.001).
Our analysis also revealed an 82% responders rate by day 3, which was statistically significant (p-value = .001). There were no drug-related serious adverse events (SAE’s) in the patient population or viral rebounds by day 14. The positive data from this clinical trial provided the rationale of dosing and protocol design for study in an upcoming phase 2/3 registrational trial.
The full text of the journal article is located at the following link.
“It’s clear in scientific circles that the risk of another pandemic in the next couple of years is very high,” said Dr Alben Sigamani, Bioxytran’s consulting Medical Director. “Driving future pandemics will be mutations of COVID-19 that have immune evasive properties negating the effect of widespread immunity and vaccines. We need a universal therapy that can treat any future mutations of COVID-19. Should the oral therapy of PL-M get regulatory approval, it lends itself well to being the new standard of care in treating upper respiratory infections like COVID-19. There is also very strong evidence that the dramatic reduction in viral load will stymie the transmissibility of future viruses. The journal suggests that the ability of PL-M to quickly reduce the viral load lends itself well to prophylaxis during pandemic conditions.”
“When we look at how PL-M defeats COVID-19 it does it through a very efficient neutralization of the virus in regions of the body where the virus initially gains a foothold. The molecule interferes with the virus’s ability to enter tissue by blocking the “Galectin Fold.” The Galectin Fold is a universal region on the spike protein that his highly conserved and makes it an ideal binding region for our molecule. Based on this regions importance in facilitating viral entry it is unlikely to see any dominant mutations that would promote a loss of function in the virus. Endemic viruses tend to gain in function. We are committed to creating a platform technology that is able to battle any mutations.”
About Bioxytran, Inc.
Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com
This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws.