Bioxytran Receives Approval to Initiate Trials With ProLectin-I
Bioxytran Receives Approval to Initiate Trials With ProLectin-I
BOSTON, MASSACHUSETTS, Feb. 06, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: 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 evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ProLectin-I injection. The objective of this trial is to provide guidance for our future Phase II trial in Long COVID and Idiopathic Pulmonary Fibrosis (IPF). This is a separate and additional approval from the authorization that ProLectin-M received on December 2, 2022.
馬薩諸塞州波士頓，2023年2月6日(Global Newswire)--BIOXYTRAN，Inc.該公司是一家臨牀階段生物技術公司，開發治療新冠肺炎和其他病毒性疾病的口服和靜脈藥物。該公司宣佈收到印度中央藥物標準控制組織的研究用新藥(IND)授權書，以評估普羅列汀-I注射劑的安全性、耐受性、藥代動力學和藥效學。這項試驗的目的是為我們未來在Long COVID和特發性肺纖維化(IPF)的第二階段試驗提供指導。這是與ProLectin-M於2022年12月2日獲得的授權不同的額外批准。
About ProLectin-I
關於ProLectin-I
ProLectin-I is an intravenous new chemical entity drug that is expected to treat Long COVID and Idiopathic Pulmonary Fibrosis (IPF). Long COVID is estimated to have 65 – 100 million cases worldwide.1,2 The CDC believes it affects one in five people that contract COVID-19. According to Harvard University, the economic cost of Long COVID is $3.7 trillion in the just the United States.3 IPF affects approximately 3 million people worldwide.4 The disease primarily affects patients over the age of 50 and affects more men than women. 5
ProLectin-I是一種靜脈注射的新型化學實體藥物，有望治療慢性冠狀病毒病和特發性肺纖維化(IPF)。據估計，全球有6500萬至1億例Long CoVID病例。1,2疾控中心認為，每五名新冠肺炎患者中就有一人受到影響。根據哈佛大學的數據，僅在美國，長期COVID的經濟成本就高達3.7萬億美元。3IPF影響着全球約300萬人。4這種疾病主要影響50歲以上的患者，男性比女性更多。5
The top theory behind the pathogenesis of Long Covid is viral persistence6 or viral fragments. ProLectin-I binds to the 'galectin fold' of the spike protein thereby neutralizing a replication competent viruses' ability to infect other cells, but it also binds to spike protein fragments thought to be the cause of ongoing inflammation. 7
長Covid發病機制的首要理論是病毒持續存在6或病毒片段。ProLectin-I與S蛋白的“Galectin摺疊”結合，從而中和複製能力強的病毒感染其他細胞的能力，但它也與被認為是持續炎症的原因的S蛋白片段結合。7
The medical term for scar tissue is fibrin. The word fibrosis stems from the continued growth of fibrin. Once scar tissue forms in the lungs combined with an already suppressed immune system, scar tissue can start to spread quickly. The reason for scar tissue forming in the lungs can vary, but it can always be associated with the onset of lung damage. Combining lung damage with an impaired immune system leads to scar tissue forming in the lungs. Multiple galectin types are associated with fibrosis, and ProLectin-I is thought to bind to a few.
疤痕組織的醫學術語是纖維蛋白。纖維化一詞源於纖維蛋白的持續生長。一旦肺部形成疤痕組織，再加上已經受到抑制的免疫系統，疤痕組織就會開始迅速擴散。肺部疤痕組織形成的原因可能各有不同，但它總是與肺損傷的發生有關。肺損傷和免疫系統受損會導致肺部形成疤痕組織。多種類型的Galectin與纖維化有關，ProLectin-I被認為與少數類型的Galectin結合。
About Bioxytran, Inc.
關於雙氧雜環丙烷公司
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 candidates, ProLectin-M ("PLM") and ProLectin-I ("PLI"), are a new class of antiviral drugs designed to antagonize galectins implicated in viral, inflammatory, fibrotic, and malignant diseases. Bioxytran's other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at
Bioxtran，Inc.是一家臨牀階段的生物技術公司，開發新的療法，旨在治療病毒學、退行性疾病和缺氧方面尚未得到滿足的重大醫療需求。主要候選藥物ProLectin-M(“PLM”)和ProLectin-I(“PLI”)是一類新型抗病毒藥物，旨在對抗與病毒、炎症、纖維化和惡性疾病有關的Galectin。Bioxtran的其他開發項目是肺纖維化和中風治療。欲瞭解更多信息，請訪問
Investor Relations
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com
投資者關係
邁克爾·謝赫
509-991-0245
郵箱：mike.sheikh@bioxtraninc.com
Forward-Looking Statements
前瞻性陳述
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.
本新聞稿包括聯邦法律規定的前瞻性陳述，包括本新聞稿中描述的與技術性能有關的陳述。這些前瞻性表述通常由“相信”、“預期”、“預期”、“估計”、“打算”、“計劃”以及類似的表述來識別，儘管並不是所有前瞻性表述都包含這些可識別的詞語。此類陳述會受到重大風險、假設和不確定性的影響。已知的可能導致Bioxtran的實際結果與這些前瞻性陳述預期的結果大不相同的重大因素在前瞻性陳述中描述，風險因素在公司截至2021年12月31日的財政年度的Form 10-K年度報告中描述，這些風險因素在提交給美國證券交易委員會的其他文件中不時列出。除聯邦證券法要求的範圍外，Bioxtran沒有義務糾正或更新任何前瞻性陳述，無論是由於新信息、未來事件或其他原因。
1Davis, H.E., McCorkell, L., Vogel, J.M. et al. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol (2023).
1首頁--期刊主要分類--期刊細介紹--期刊題錄與文摘--期刊詳細內容等人的研究。Long COVID：主要發現、機制和建議。NAT版本微生物 (2023).
2 Chen Chen, et al. Global Prevalence of Post-Coronavirus Disease 2019 (COVID-19) Condition or Long COVID: A Meta-Analysis and Systematic Review, The Journal of Infectious Diseases, Volume 226, Issue 9, 1 November 2022, Pages 1593–1607,
2陳晨，等人。2019年冠狀病毒後疾病(新冠肺炎)全球流行情況或長期冠狀病毒感染：Meta分析和系統評價，《傳染病雜誌》，第226卷，第9期，2022年11月1日，第1593-1607頁，
3 Cutler, D.M. The Economic Cost of Long Covid: An Update. Harvard University, July 2022.
3《長覆冰的經濟成本：最新進展》。哈佛大學，2022年7月。
4 Nalysnyk, L., et al. Incidence and Prevalence of Idiopathic Pulmonary Fibrosis: Review of the Literature. Eur. Respir. Rev. 2012;21(126):355-361
4Nalysnyk，L.等人。特發性肺纖維化的發病率和患病率：文獻綜述。歐元。響應者。雷夫. 2012;21(126):355-361
5 Raghu, G., et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med. 2011; 183:788–824
5拉古，G.等人。ATS/ERS/JRS/ALAT的官方聲明：特發性肺纖維化：循證診斷和治療指南。Am J Respir CRUT CARE Med。 2011; 183:788–824
6 Peluso, M.J. and Deeks, S.G. Early clues regarding the pathogenesis of long-COVID. Trends in Immunology, Volume 43, Issue 4, April 2022, Pages 268-270.
6Peluso，M.J.和Deek，S.G.，關於長冠狀病毒病發病機制的早期線索。免疫學的發展趨勢，第43卷，第4期，2022年4月，第268-270頁。
7 Patterson BK, et al. (2022). Persistence of SARS CoV-2 S1 Protein in CD16+ Monocytes in Post-Acute Sequelae of COVID-19 (PASC) up to 15 Months Post-Infection. Front. Immunol. 12:746021. doi: 10.3389/fimmu.2021.746021
7帕特森·BK，等人。(2022年)。新冠肺炎急性後遺症患者外周血單核細胞中SARS冠狀病毒-2 S1蛋白持續時間長達15個月。前面。免疫系統。12：746021。網址：10.3389/fimmu.2021.746021
譯文內容由第三人軟體翻譯。