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AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9, An Inflammatory Biomarker of Dry Eye Disease

AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9, An Inflammatory Biomarker of Dry Eye Disease

Axim Biotech開發乾眼病炎性生物標誌物MMP-9的快速定量淚液測試
GlobeNewswire ·  2022/03/08 22:07

SAN DIEGO, March 08, 2022 (GLOBE NEWSWIRE) -- AXIM Biotechnologies, Inc (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting dry eye disease (DED), today announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease.

聖迭戈,2022年3月8日(環球通訊社)-Axim BioTechnologies,Inc(OTCQB:AXIM)(“Axim Biotech,”Axim“或”The Company“),一家針對乾眼病(DED)的國際醫療解決方案公司今天宣佈,它已成功開發出一種針對乾眼病(DED)炎症生物標誌物MMP-9的快速定量淚液檢測方法。

Dry Eye Disease, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of Dry Eye Disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of Dry Eye Disease. The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

乾眼症雖然很普遍,但被低估了,部分原因是症狀並不總是與客觀體徵相關。它在疾病的不同階段具有高度可變的症狀特徵,並且在體徵和症狀之間經常存在不一致。一名患者可能有嚴重的症狀,但沒有眼表損傷的跡象,而另一些患者則有晚期的眼表損傷,但沒有任何症狀。乾眼病的臨牀體徵和症狀之間缺乏相關性,這給患者的診斷和治療帶來了挑戰。很多時候,炎症在乾眼病的臨牀症狀出現之前就已經出現了。挑戰在於早期發現炎症。基質金屬蛋白酶-9(MMP-9),一種在乾眼症患者淚液中持續升高的炎性生物標誌物,當檢測到時可能會加速早期診斷。

Dr. Joseph Tauber, AXIM's Chief Medical Officer, underscored the importance as well as the challenge in accurately measuring levels of MMP-9: "The central role of inflammation in ocular surface disease is widely recognized, but our ability to measure this in the clinic has been limited to the InflammaDry test that measures tear matrix metalloproteinase (MMP) levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This 'yes or no' report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and thus may miss clinically significant improvement that did not reach that threshold."

Axim首席醫療官Joseph Tauber博士強調了精確檢測MMP-9水平的重要性和挑戰性:“炎症在眼表疾病中的核心作用已得到廣泛認可,但我們在臨牀上檢測這一點的能力僅限於InflammaDry檢測,該檢測方法可檢測淚液基質金屬蛋白酶(MMP)水平,並提供約40 ng/ml的MMP-9陽性/陰性結果。這份“是或否”的報告具有臨牀價值,但它是有限的。目前可用的MMP-9檢測只有在濃度降至40 ng/ml以下時才能檢測到淚液MMP-9水平的降低,因此可能會錯過未達到該閾值的臨牀顯著改善。“

The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery. "The availability of quantitative tear MMP-9 testing would be a significant advance in our ability to measure the degree of inflammation affecting our dry eye patients, allowing for more objective classification of their disease," said Dr. Joseph Tauber. "Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for ocular surface disease, including pharmaceuticals, thermal pulsation treatments and even light based therapies."

MMP-9定量檢測作為乾眼病準確診斷和後續治療的一種工具,其臨牀益處包括更準確的手術前和手術後結果。術後併發症,例如角膜傷口癒合,是通過在手術前識別乾眼來促進的。約瑟夫·陶伯博士説:“淚液基質金屬蛋白酶-9定量檢測的可獲得性將大大提高我們測量影響乾眼患者炎症程度的能力,從而對他們的疾病進行更客觀的分類。”“同樣重要的是衡量炎症控制改善的能力,這是我們治療眼表疾病的許多療法的目標,包括藥物、熱脈動療法,甚至是基於光的療法。”

John Huemoeller, AXIM's CEO stated: "Some reports indicate that nearly half of all U.S. adults experience dry eye symptoms and 33% of patients in eye care clinics present with complaints about dry eye. Given the size of the market, AXIM made the strategic decision to develop a test for MMP-9 to assist in early detection of Dry Eye Disease. Together with our Lactoferrin and IgE Tests and now with the addition of our MMP-9 Test, AXIM will be positioned to corner the market for Dry Eye Disease diagnostic testing."

Axim首席執行官John Huemoeller表示:“一些報告顯示,近一半的美國成年人出現乾眼症狀,眼科診所33%的患者出現乾眼症狀。考慮到市場的規模,Axim做出了戰略性決定,開發一種MMP-9測試來幫助早期發現乾眼病。連同我們的乳鐵蛋白和IgE測試,再加上我們的MMP-9測試,Axim將壟斷乾眼病診斷測試市場。”

About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications. For more information, please visit .

關於Axim®生物技術
Axim®BioTechnologies,Inc.(Axim)成立於2014年,是一家垂直整合的研發公司,致力於通過快速診斷測試改善乾眼病(DED)等眼科疾病的診斷環境。此外,它還擁有知識產權,並對新冠肺炎(SARS-CoV-2)快速中和抗體測試進行研究,以檢測據信可以阻止SARS-CoV-2進入宿主細胞的功能性中和抗體水平,以及腫瘤學適應症。有關更多信息,請訪問。

Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will be successfully shown to detect SARS-CoV-2 neutralizing antibodies, that the diagnostic candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the diagnostic candidate can be manufactured in large quantities or that third parties with an established presence in blood collection clinics, vaccine development, employer or individual use will enter into agreements or purchase from the Company, and even if the Company's diagnostic candidate is successful, it may generate only limited revenue and profits for the Company, including whether any of Axim's diagnostic products will receive clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to sell its products and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the fact that there has never been a commercial diagnostic test utilizing neutralizing antibodies approved for use and various other factors detailed from time to time in Axim's SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

前瞻性陳述
Axim BioTechnologies Inc.在本新聞稿中所作的陳述可能是1933年“證券法”第27A節、1934年“證券交易法”第21E節和1995年“私人證券訴訟改革法”所指的“前瞻性”性質。前瞻性陳述描述了Axim的未來計劃、預測、戰略和預期,這些都是基於假設的,涉及許多風險和不確定性,其中許多風險和不確定性不在Axim BioTechnologies,Inc.的控制範圍之內。實際結果可能與預測的結果大不相同,因為不能保證我們的候選診斷能成功檢測SARS-CoV-2中和抗體,不能保證該診斷候選能被美國FDA或任何同等的外國監管機構批准使用,不能保證該診斷候選能大量生產,不能保證第三方有既定的存在,也不能保證我們的診斷候選能成功地檢測到SARS-CoV-2中和抗體,不能保證診斷候選能被美國FDA或任何同等的外國監管機構批准使用,不能保證診斷候選能大量生產,也不能保證第三方有既定的存在疫苗開發、僱主或個人使用將與公司簽訂協議或從公司購買,即使公司的候選診斷獲得成功,也可能只會為公司帶來有限的收入和利潤,包括Axim的任何診斷產品是否會獲得美國食品和藥物管理局(FDA)或同等外國監管機構的許可,可以銷售其產品,以及是否以及何時獲得美國FDA或同等外國監管機構的最終批准。事實上,從來沒有使用獲得批准使用的中和抗體進行商業診斷測試的情況,以及Axim不時在提交給美國證券交易委員會的美國證券交易委員會報告和文件中詳細描述的各種其他因素,這些報告包括我們在2021年4月15日提交給美國證券交易委員會的10-K表格年度報告,以及我們提交給美國證券交易委員會的其他報告,這些報告可在www.sec.gov上查閲。Axim BioTechnologies,Inc., 除非法律另有要求,否則沒有義務公開更新任何前瞻性陳述,以反映本新聞稿日期後的新信息、事件或情況,或反映意外事件的發生。

CONTACT
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San Diego, CA 92121, USA
P. 858-923-4422

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