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, March 29, 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.
"After considering all the clinical data and tests it is clear that ProLectin-M could play a major role in treating future pandemics. The drug dramatically reduced the viral load which in turn shuts down the transmission of the virus. Recent analysis reveals that reducing the number of days of infectivity can have a dramatic impact on the number of overall infections, hospitalizations, and economic burden" said Dr. Alben Sigamani, a member of Bioxytran's Medical Advisory Board. Dr. Sigamani continued by stating "The key to stopping this cycle of immune evasion is to quickly treat the infected and provide prophylaxis to those exposed. The trial results demonstrate we may be able to do both. This is why we are looking forward to starting our dosage optimization study which will inform our Phase 3 study and future trial designs."
"Existing therapies target viral replication which battles on the inside of the cell interfering with replication, our Galectin Antagonist helps keep the fight outside the cell interfering with cellular entry. This novel Mechanism of Action in battling viruses may require little assistance from the immune system, which typically requires a lead time to mount a response. With the creation of this molecule, we contribute to the science of Glycovirology, which is the study of carbohydrates and viruses."
"This is truly a groundbreaking study that demonstrates the proof of concept of a carbohydrate molecule capable to influence and block infection by a virus." said Dr. Hana Chen-Walden, Medical Director of Bioxytran. "In the past, before the COVID-19 epidemic, vaccines were used to stop the viral spread and thus eradicate the disease. This ideal was not supported by the new COVID19 vaccines, in face of the continuation of the spread of the virus with the appearance of new mutant virus variants which were not controlled by the vaccine. It became evident that other tools will have to be used against the spread of disease contributing to its prophylaxis".
"We intend to explore not only COVID-19, but also other viruses and indications. The underlying concept of Glycovirology, is that viral and human membranes are glycosylated. The Galectin Fold or the protein receptors called Lectins which recognize only carbohydrates chemical structures are unique to each virus. Our challenge will be to identify the unique galectins structure on each virus and then the specific complex carbohydrate chemical structures that will bind to the galectin fold to achieve complete binding and inhibition of viral entry. Recent journal articles have demonstrated the utility of using high power resolution of NMR mathematical calculations as drug design tool to quickly assess the binding affinity theoretically. It is for these reasons we believe we have a vast and major novel platform technology that could effectively treat other serious viral diseases."
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
Investor Relations
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com
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.
在第7天,100%的患者完全消除了病毒載量,而服用安慰劑的患者只有6%(p=.001)
大多數癥狀在第7天前完全消除
半乳糖凝集素拮抗劑在新冠肺炎治療中的作用
波士頓,馬薩諸塞州,2023年3月29日(Global Newswire)--BIOXYTRAN,Inc.該公司是一家臨床階段生物技術公司,正在開發治療新冠肺炎和其他病毒性疾病的口服藥物。該公司宣佈,該雜誌疫苗%s該公司發表了一篇同行評議文章,題為《新冠肺炎中的口服Galectin抑制劑-A期隨機對照試驗》,其中包含了該公司在34名輕中度新冠肺炎患者中進行的隨機、安慰劑對照的第2期臨床試驗的主要安全性和有效性結果。在7天的治療中,口服Galectin拮抗劑咀嚼片劑。試驗的終點是病毒載量在統計上顯著減少,這是通過在第7天達到低於閾值PCR值(CT值≥29)的患者的數量來衡量的。此外,在接受藥物治療的組中,大多數癥狀完全消失,而安慰劑組有41.18%的患者繼續發冷,29.41%的患者有發燒的感覺,35.29%的患者在第7天咳嗽。試驗在第7天達到終點,100%的應答率高於安慰劑組的6%,這在統計學上具有統計學意義(p值=.001)。
我們的分析還顯示,到第3天,應答率為82%,這在統計學上具有統計學意義(p值=.001)。到第14天,患者群體中沒有與藥物相關的嚴重不良事件(SAE)或病毒反彈。這項臨床試驗的陽性數據為即將進行的2/3階段註冊試驗的研究提供了劑量和方案設計的理論基礎。
這篇期刊文章的全文位於以下鏈接。
Bioxtran醫療諮詢委員會成員Alben Sigamani博士說:“在考慮了所有的臨床數據和測試後,很明顯ProLectin-M可以在治療未來的大流行中發揮重要作用。這種藥物極大地減少了病毒載量,進而阻斷了病毒的傳播。最近的分析顯示,減少感染天數可以對總體感染人數、住院人數和經濟負擔產生巨大影響。”西加馬尼博士接著說,“阻止這種免疫逃避迴圈的關鍵是迅速治療感染者,並為感染者提供預防措施。試驗結果表明,我們或許能夠做到這兩點。這就是為什麼我們期待著開始劑量優化研究,這將為我們的第三階段研究和未來的試驗設計提供依據。”
現有的治療方法針對的是病毒複製,它在細胞內部進行戰鬥,幹擾複製,我們的Galectin拮抗劑幫助保持細胞外的戰鬥,幹擾細胞進入。這種新的抗擊病毒的作用機制可能不需要免疫系統的幫助,這通常需要一段時間才能產生反應。通過創造這種分子,我們對糖類病毒學做出了貢獻,這是對碳水化合物和病毒的研究。
這確實是一項開創性的研究,它證明瞭碳水化合物分子能夠影響和阻止病毒感染的概念。“Bioxtran的醫學董事醫生Hana Chen-Walden說。過去,在新冠肺炎流行之前,疫苗被用來阻止病毒的傳播,從而根除疾病。這一理想沒有得到新的COVID19疫苗的支持,因為面對病毒的持續傳播,出現了不受疫苗控制的新的突變病毒變體。很明顯,將不得不使用其他工具來阻止疾病的傳播,從而有助於預防它。
我們不僅打算探索新冠肺炎,還打算探索其他病毒和適應症。糖病毒學的基本概念是病毒和人膜是糖基化的。Galectin折疊或稱為凝集素的蛋白質受體只識別碳水化合物,其化學結構對每種病毒都是獨特的。我們的挑戰將是確定每個病毒上獨特的Galectins結構,然後確定與Galectin折疊結合的特定複雜碳水化合物化學結構,以實現完全結合和抑制病毒進入。最近的期刊文章證明瞭使用高功率解析度的核磁共振數學計算作為藥物設計工具在理論上快速評估結合親和力的有效性。正是出於這些原因,我們相信我們擁有一項巨大而重大的新型平臺技術,可以有效地治療其他嚴重的病毒性疾病。
Bioxtran公司簡介
Bioxtran,Inc.是一家臨床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是一種新型抗病毒藥物,旨在對抗與炎症、纖維化和惡性疾病有關的Galectins。Bioxtran的其他開發專案是肺纖維化和中風治療。欲瞭解更多資訊,請訪問
投資者關係
邁克爾·謝赫
509-991-0245
郵箱:mike.sheikh@bioxtraninc.com
前瞻性陳述
本新聞稿包括聯盟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檔案中不時列出。除聯盟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,無論是由於新資訊、未來事件或其他原因。