share_log

Altamira Therapeutics Announces Publication of Positive Results From Bentrio Trial in Seasonal Allergic Rhinitis in Top Peer Reviewed Journal

Altamira Therapeutics Announces Publication of Positive Results From Bentrio Trial in Seasonal Allergic Rhinitis in Top Peer Reviewed Journal

Altamira Therapeutics宣佈在頂級同行評審期刊上發表Bentrio季節性過敏性鼻炎試驗的陽性結果
Altamira Therapeutics ·  04/24 12:00

Hamilton, Bermuda, April 24, 2024 (GLOBE NEWSWIRE) --

百慕大漢密爾頓,2024 年 4 月 24 日(GLOBE NEWSWIRE)—


  • Detailed results from randomized controlled Bentrio trial in seasonal allergic rhinitis published in Allergy journal
  • Study met primary efficacy endpoint of improvement in nasal symptoms (p = 0.013)
  • Corroborated by statistically significant improvement in health-related quality of life and reduced need for relief medication
  • Study outcomes support plans for further international expansion
  • 發表在《過敏》雜誌上的季節性過敏性鼻炎隨機對照的Bentrio試驗的詳細結果
  • 該研究達到了改善鼻部症狀的主要療效終點(p = 0.013)
  • 健康相關生活質量的顯著改善和對救濟藥物需求的減少證實了這一點
  • 研究結果支持進一步國際擴張的計劃

HAMILTON, BERMUDA -- April 24, 2024 -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today announced the publication of the detailed results from the NASAR clinical trial with Bentrio nasal spray in seasonal allergic rhinitis (SAR). The peer-reviewed article appeared in Allergy,1 which is published by the European Academy of Allergy and Clinical Immunology and recognizes as one of the highest-ranking journals in the field of allergology. Bentrio (AM-301) is a drug-free and preservative-free nasal spray designed to help protect against airborne allergens such as pollen or house dust mites.

哈米爾TON,百慕大 ——四月 24,2024—— Altamira Therapeutics Ltd.(“Altamira” 或 “公司”)(納斯達克股票代碼:CYTO)是一家致力於開發和商業化肝臟以外靶點的RNA遞送技術的公司,今天宣佈公佈了NASAR使用Bentrio鼻噴霧劑治療季節性過敏性鼻炎(SAR)的臨床試驗的詳細結果。這篇經過同行評審的文章發表在《過敏》中,1 它由歐洲過敏和臨床免疫學學會出版,被公認爲過敏學領域排名最高的期刊之一。Bentrio(AM-301)是一種不含藥物和不含防腐劑的鼻腔噴霧劑,旨在幫助防止空氣中的過敏原,例如花粉或室內塵蟎。

The NASAR trial enrolled 100 patients during two allergy seasons in Australia who were randomized at a 1:1 ratio to receive either Bentrio or saline nasal spray, the current standard of care in drug-free SAR management. Study participants self-administered the treatment for two weeks three times per day. The primary efficacy endpoint was the reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS; ANCOVA model).

NASAR試驗在澳大利亞的兩個過敏季節招收了100名患者,他們以 1:1 的比例隨機接受Bentrio或鹽水鼻腔噴霧劑,這是目前無藥SAR管理的護理標準。研究參與者每天三次自行進行爲期兩週的治療。主要療效終點是平均每日反射性總鼻腔症狀評分(RTNSS;ANCOVA模型)降低。

Bentrio-treated patients achieved a significantly lower rTNSS than the saline group (least square means difference -1.1, p = 0.013) with improvement observed across all individual nasal symptoms. Health-related quality of life, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), was significantly improved as well (p < 0.001). Patients and investigators rated the efficacy of treatment as significantly better with Bentrio compared to saline control (both p < 0.001). Both treatments showed similarly good safety and tolerability. With Bentrio, fewer patients used relief medication and more enjoyed symptom-free days compared to saline treatment.

接受Bentrio治療的患者的RTNS明顯低於鹽水組(最小二乘均值差異爲-1.1,p = 0.013),所有個體鼻部症狀均有改善。根據鼻結膜炎生活質量問卷(RQLQ)測量,與健康相關的生活質量也得到了顯著改善(p

"We are thrilled to see the detailed results from our pivotal Australian trial published in one the leading medical journals in allergology," commented Thomas Meyer, Altamira's founder, Chairman, and CEO. "The study provided a wealth of additional evidence for the protective effects of Bentrio as well as its good safety and tolerability. In addition, we are very encouraged to see that Bentrio helps to manage not only mild allergy symptoms, but also more severe ones, and appears to reduce the need for the use of drug-based relief treatments. We would like to thank all participating patients and study sites for their contributions to the NASAR trial and look forward to making Bentrio available in additional countries and helping patients who have to deal with the daily burden and discomfort associated with allergic rhinitis."

Altamira的創始人、董事長兼首席執行官托馬斯·邁耶評論說:“我們很高興看到我們在過敏學領域領先的醫學期刊上發表的澳大利亞關鍵試驗的詳細結果。”“該研究爲Bentrio的保護作用及其良好的安全性和耐受性提供了大量額外證據。此外,我們非常鼓舞地看到,Bentrio不僅有助於控制輕微的過敏症狀,而且還有助於控制更嚴重的過敏症狀,並且似乎減少了使用藥物緩解療法的需求。我們要感謝所有參與的患者和研究機構對NASAR試驗的貢獻,並期待將Bentrio推廣到其他國家,並幫助必須應對與過敏性鼻炎相關的日常負擔和不適的患者。”

Bentrio is marketed by Altamira Medica AG, an associate company of Altamira Therapeutics, primarily through distributors. From 2024 onwards, Altamira Medica expects sales to grow significantly, mainly driven by the launch of Bentrio in additional countries. The Company expects to conclude partnering discussions and negotiations for distribution in the US, Europe and other key markets in the course of 2024.

Bentrio由Altamira Therapeutics的關聯公司Altamira Medica AG主要通過分銷商銷售。Altamira Medica預計,從2024年起,銷售額將大幅增長,這主要是由Bentrio在其他國家的推出所推動的。該公司預計將在2024年結束關於在美國、歐洲和其他主要市場分銷的合作討論和談判。

About Altamira Therapeutics

關於阿爾塔米拉療法

Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore / SemaPhore platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in Altamira Medica AG, its commercial-stage legacy asset Bentrio, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets. Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/

Altamira Therapeutics(納斯達克股票代碼:CYTO)正在開發和提供基於肽的納米顆粒技術,用於將RNA高效輸送到肝外組織(Oligophore/SemaPhore平台)。該公司目前有兩個使用其專有交付技術的旗艦siRNA項目:用於KRAS驅動的癌症的 AM-401 和用於類風溼關節炎的 AM-411,均在體內概念驗證以外的臨床前開發中。多功能交付平台還適用於mRNA和其他 RNA 模式,並通過外包許可提供給制藥或生物技術公司。此外,阿爾塔米拉持有Altamira Medica AG49%的股份(還有額外的經濟權利)。Altamira Medica AG是其商業階段的遺產資產Bentrio,一家治療過敏性鼻炎的非處方鼻腔噴霧劑。此外,該公司正在合作/剝離其內耳遺留資產。Altamira成立於2003年,總部位於百慕大漢密爾頓,主要業務位於瑞士巴塞爾。欲了解更多信息,請訪問: https://altamiratherapeutics.com/

Forward-Looking Statements

前瞻性陳述

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of strategic transactions, including licensing or partnering, with respect to Altamira's legacy assets, Altamira's need for and ability to raise substantial additional funding to continue the development of its product candidates, the clinical utility of Altamira's product candidates, the timing or likelihood of regulatory filings and approvals, Altamira's intellectual property position and Altamira's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira's Annual Report on Form 20-F for the year ended December 31, 2023, and in Altamira's other filings with the Securities Exchange Commission ("SEC"), which are available free of charge on the SEC's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.

本新聞稿可能包含構成經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的 “前瞻性陳述” 的陳述。前瞻性陳述是歷史事實以外的陳述,可能包括涉及未來運營、財務或業務業績或阿爾塔米拉戰略或預期的陳述。在某些情況下,您可以通過諸如 “可能”、“可能”、“將”、“應該”、“期望”、“計劃”、“預期”、“相信”、“估計”、“預測”、“項目”、“潛力”、“展望” 或 “繼續” 等前瞻性詞語來識別這些陳述,或者這些術語或其他類似術語的否定詞。前瞻性陳述基於管理層當前的預期和信念,涉及重大風險和不確定性,可能導致實際業績、發展和業務決策與這些陳述所設想的存在重大差異。這些風險和不確定性包括但不限於與阿爾塔米拉遺留資產有關的戰略交易(包括許可或合作)的成功、阿爾塔米拉爲繼續開發其候選產品而籌集大量額外資金的需求和籌集大量額外資金的能力、阿爾塔米拉候選產品的臨床效用、監管機構申報和批准的時間或可能性、阿爾塔米拉的知識產權狀況和阿爾塔米拉的財務狀況,包括未來任何收購、處置的影響,合夥企業、許可交易或Altamira資本結構的變化,包括未來的證券發行。這些風險和不確定性還包括但不限於阿爾塔米拉截至2023年12月31日止年度的20-F表年度報告以及阿爾塔米拉向證券交易委員會(“SEC”)提交的其他文件中 “風險因素” 標題下描述的風險和不確定性,這些文件可在美國證券交易委員會的網站上免費獲得,網址爲:www.sec.gov。如果其中一種或多種風險或不確定性成爲現實,或者基本假設被證明不正確,則實際結果可能與所示結果存在重大差異。所有前瞻性陳述以及隨後歸因於阿爾塔米拉或代表阿爾塔米拉行事的人的所有書面和口頭前瞻性陳述均根據這些風險和不確定性進行了明確的全部限定。您不應過分依賴前瞻性陳述。前瞻性陳述僅代表其發表之日,除非適用法律另有要求,否則阿爾塔米拉不承擔任何義務根據新信息、未來發展或其他方面對其進行更新。

Investor Contact:

投資者聯繫人:

1 Becker S, Deshmukh S, De Looze F, et al. AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial. Allergy. 2024;00:1-10. https://onlinelibrary.wiley.com/doi/10.1111/all.16116

1 Becker S、Deshmukh S、De Looze F 等AM-301,一種形成屏障的鼻腔噴霧劑,與鹽水噴霧在季節性過敏性鼻炎中的對比:一項隨機臨床試驗。過敏。2024;00:1-10。 https://onlinelibrary.wiley.com/doi/10.1111/all.16116

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論