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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宣布在顶级同行评审期刊上发表Bentrio季节性过敏性鼻炎试验的阳性结果
Altamira Therapeutics ·  04/24 00:00

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

百慕大汉密尔顿,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
  • 发表在《过敏》杂志上的季节性过敏性鼻炎随机对照的Bentrio试验的详细结果
  • 该研究达到了改善鼻部症状的主要疗效终点(p = 0.013)
  • 健康相关生活质量的显著改善和对救济药物需求的减少证实了这一点
  • 研究结果支持进一步国际扩张的计划

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.

哈米尔TON,百慕大 ——四月 24,2024—— Altamira Therapeutics Ltd.(“Altamira” 或 “公司”)(纳斯达克股票代码:CYTO)是一家致力于开发和商业化肝脏以外靶点的RNA递送技术的公司,今天宣布公布了NASAR使用Bentrio鼻喷雾剂治疗季节性过敏性鼻炎(SAR)的临床试验的详细结果。这篇经过同行评审的文章发表在《过敏》中,1 它由欧洲过敏和临床免疫学学会出版,被公认为过敏学领域排名最高的期刊之一。Bentrio(AM-301)是一种不含药物和不含防腐剂的鼻腔喷雾剂,旨在帮助防止空气中的过敏原,例如花粉或室内尘螨。

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试验在澳大利亚的两个过敏季节招收了100名患者,他们以 1:1 的比例随机接受Bentrio或盐水鼻腔喷雾剂,这是目前无药SAR管理的护理标准。研究参与者每天三次自行进行为期两周的治疗。主要疗效终点是平均每日反射性总鼻腔症状评分(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治疗的患者的RTNS明显低于盐水组(最小二乘均值差异为-1.1,p = 0.013),所有个体鼻部症状均有改善。根据鼻结膜炎生活质量问卷(RQLQ)测量,与健康相关的生活质量也得到了显著改善(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的创始人、董事长兼首席执行官托马斯·迈耶评论说:“我们很高兴看到我们在过敏学领域领先的医学期刊上发表的澳大利亚关键试验的详细结果。”“该研究为Bentrio的保护作用及其良好的安全性和耐受性提供了大量额外证据。此外,我们非常鼓舞地看到,Bentrio不仅有助于控制轻微的过敏症状,而且还有助于控制更严重的过敏症状,并且似乎减少了使用药物缓解疗法的需求。我们要感谢所有参与的患者和研究机构对NASAR试验的贡献,并期待将Bentrio推广到其他国家,并帮助必须应对与过敏性鼻炎相关的日常负担和不适的患者。”

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的关联公司Altamira Medica AG主要通过分销商销售。Altamira Medica预计,从2024年起,销售额将大幅增长,这主要是由Bentrio在其他国家的推出所推动的。该公司预计将在2024年结束关于在美国、欧洲和其他主要市场分销的合作讨论和谈判。

About Altamira Therapeutics

关于阿尔塔米拉疗法

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(纳斯达克股票代码:CYTO)正在开发和提供基于肽的纳米颗粒技术,用于将RNA高效输送到肝外组织(Oligophore/SemaPhore平台)。该公司目前有两个使用其专有交付技术的旗舰siRNA项目:用于KRAS驱动的癌症的 AM-401 和用于类风湿关节炎的 AM-411,均在体内概念验证以外的临床前开发中。多功能交付平台还适用于mRNA和其他 RNA 模式,并通过外包许可提供给制药或生物技术公司。此外,阿尔塔米拉持有Altamira Medica AG49%的股份(还有额外的经济权利)。Altamira Medica AG是其商业阶段的遗产资产Bentrio,一家治疗过敏性鼻炎的非处方鼻腔喷雾剂。此外,该公司正在合作/剥离其内耳遗留资产。Altamira成立于2003年,总部位于百慕大汉密尔顿,主要业务位于瑞士巴塞尔。欲了解更多信息,请访问: https://altamiratherapeutics.com/

Forward-Looking Statements

前瞻性陈述

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.

本新闻稿可能包含构成经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的 “前瞻性陈述” 的陈述。前瞻性陈述是历史事实以外的陈述,可能包括涉及未来运营、财务或业务业绩或阿尔塔米拉战略或预期的陈述。在某些情况下,您可以通过诸如 “可能”、“可能”、“将”、“应该”、“期望”、“计划”、“预期”、“相信”、“估计”、“预测”、“项目”、“潜力”、“展望” 或 “继续” 等前瞻性词语来识别这些陈述,或者这些术语或其他类似术语的否定词。前瞻性陈述基于管理层当前的预期和信念,涉及重大风险和不确定性,可能导致实际业绩、发展和业务决策与这些陈述所设想的存在重大差异。这些风险和不确定性包括但不限于与阿尔塔米拉遗留资产有关的战略交易(包括许可或合作)的成功、阿尔塔米拉为继续开发其候选产品而筹集大量额外资金的需求和筹集大量额外资金的能力、阿尔塔米拉候选产品的临床效用、监管机构申报和批准的时间或可能性、阿尔塔米拉的知识产权状况和阿尔塔米拉的财务状况,包括未来任何收购、处置的影响,合伙企业、许可交易或Altamira资本结构的变化,包括未来的证券发行。这些风险和不确定性还包括但不限于阿尔塔米拉截至2023年12月31日止年度的20-F表年度报告以及阿尔塔米拉向证券交易委员会(“SEC”)提交的其他文件中 “风险因素” 标题下描述的风险和不确定性,这些文件可在美国证券交易委员会的网站上免费获得,网址为:www.sec.gov。如果其中一种或多种风险或不确定性成为现实,或者基本假设被证明不正确,则实际结果可能与所示结果存在重大差异。所有前瞻性陈述以及随后归因于阿尔塔米拉或代表阿尔塔米拉行事的人的所有书面和口头前瞻性陈述均根据这些风险和不确定性进行了明确的全部限定。您不应过分依赖前瞻性陈述。前瞻性陈述仅代表其发表之日,除非适用法律另有要求,否则阿尔塔米拉不承担任何义务根据新信息、未来发展或其他方面对其进行更新。

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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-301,一种形成屏障的鼻腔喷雾剂,与盐水喷雾在季节性过敏性鼻炎中的对比:一项随机临床试验。过敏。2024;00:1-10。 https://onlinelibrary.wiley.com/doi/10.1111/all.16116

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