BIXT 8-K
Bioxytran, Inc (BIXT)
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT
REPORT
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Item 8.01 Other Events.
On December 2, 2022, Bioxytran (the “Company”) has through India’s Central Drugs Standard Control Organisation (CDSCO) received permission in form CT -06, No. CT/ND/ /2022, under the provisions of New Drugs and Clinical Trial Rules, 2019, to conduct: “A Phase 1b/2a Randomized, Blinded, placebo-controlled Study in Participants with Mild to Moderate COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Orally Administered ProLectin-M” with the registration F. No. IND/CT/22/000004.
A condition for the permission is that the clinical trial at each site shall be initiated after approval of the clinical trial protocol and other related documents by the Ethics Committee of that site, registered with the Central Licensing Authority.
In connection of with the above approval the Company issued on December 8, 2022 a press-release over Newswire, under the title:
Bioxytran Receives Approval to Optimize Dosage in COVID-19 Patients
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | ||
| Number | Description | |
| 99.1 | Press-release - Bioxytran Receives Approval to Optimize Dosage in COVID-19 Patients, dated December 8, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| By: | /s/ David Platt | |
| Name: | Dr. David Platt | |
| Title: | President and Chief Executive Officer | |
Dated: December 8, 2022 | ||
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Exhibit 99.1
Bioxytran Receives Approval to Optimize Dosage in COVID-19 Patients
BOSTON, MASSACHUSETTS, December 8, 2022 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat COVID-19 and other viral diseases, announced the receipt of an Investigational New Drug (IND) authorization letter from India’s Central Drugs Standard Control Organization (CDSCO) to optimize dosage in Covid-19 patients. The trial’s objective is to provide guidance for a 408 patient Phase III trial.
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
Investor Relations
Michael Sheikh
509-991-0245
Forward-Looking Statements
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.