Bioxytran Inc (BIXT)

[De302]

Wow ! old news here for most , but I like it !


BIXT
-1.71%
Wed, November 16, 2022 at 7:00 AM
In this article:




Complete elimination of viral load in 100% of patients at day 7 vs 6% in placebo (p=.001)

Complete elimination of viral load in 88% of patients at day 3 vs 0% in placebo (p=.001)

Treated population experienced no viral rebounds within the 14-day observation period

BOSTON, Nov. 16, 2022 /PRNewswire/ -- BIOXYTRAN, INC. (OTCQB: BIXT), (the "Company"), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced positive topline safety and efficacy results of its 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 8 times per day on an hourly basis. 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. 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 88% response 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 in the patient population. 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 preprint is located at the following link.
https://www.medrxiv.org/content/10.1101/2022.11.09.22282151v1

Nuclear Magnetic Resonance ("NMR") testing was used to elucidate the Mechanism of Action of the specific Galectin Antagonist. Tests concluded that ProLectin-M ("PL-M") binds relatively strongly to galectin-3 with micromolar affinity down to 2µM. While the Galectin Antagonist does indeed bind to the S1 Spike Protein, the study showed that it could bind in 2 different orientations with galectin-3. The NMR binding data indicate that 5 molecules of galectin-3 are required to saturate one spike protein. These findings on the mechanism of action supported the decisions on dosing, duration, and ingestion. The results showed PL-M's inhibition of galectin-3 and the blockade of the N-Terminal Domain of the S-1 subunit.

"Our sights were set on a statistically significant reduction of viral load by day 7 because we expected that there would be real-world issues that we would be unable to account for in our theories about efficacy. We can say that these trial results exceeded our expectations by orders of magnitude, but the proof of that statement lies in our trial design which should have been hourly instead of daily so that we would have had a more detailed picture of how rapidly the viral load was dropping" said Dr. Alben Sigamani, Bioxytran Medical Advisory Board .