Altamira Therapeutics Continue Bentrio Clinical Trial for Seasonal Allergic Rhinitis in Australia
Altamira Therapeutics (NASDAQ:CYTO) has resumed participant enrollment in its NASAR clinical trial for the Bentrio nasal spray aimed at treating seasonal allergic rhinitis in Australia, coinciding with the onset of pollen season. The study will include 100 patients and compare the safety and efficacy of Bentrio against a saline nasal spray, with data results expected by Q1 2023. The trial, initially started in fall 2021, faced a temporary suspension in spring 2022. Interim data previously assisted in obtaining FDA clearance for Bentrio.
- Resumed enrollment in NASAR trial during peak pollen season, indicating timely clinical relevance.
- Study designed to compare Bentrio against established saline treatment, providing meaningful comparative data.
- Expectation of data results in Q1 2023 could provide insights into Bentrio's efficacy.
- Previous suspension of the NASAR trial may raise concerns about the trial's continuity and timeline.
- The ultimate success of Bentrio in the market is contingent on positive trial outcomes, which remain uncertain.
HAMILTON, BERMUDA , Oct. 03, 2022 (GLOBE NEWSWIRE) -- Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that its “NASAR” clinical trial with its BentrioTM nasal spray for seasonal allergic rhinitis (SAR) has resumed the enrollment of study participants in Australia as its pollen season is starting up again.
The NASAR trial, which will enroll a total of 100 patients suffering from SAR, is designed to compare the safety and efficacy of Bentrio against a saline nasal spray. Study participants are randomized at a 1:1 ratio to either receive Bentrio or control treatment via self-administration three times per day, or as needed, for two weeks. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score (rTNSS) under treatment with Bentrio against control.
The NASAR trial was initiated in fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US Food and Drug Administration (FDA).
“We are pleased to have the first patient randomized into the continuation of the NASAR trial as the annual pollen season starts in Australia,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO. “The NASAR study will be important to generate further ‘real life’ data from allergic rhinitis sufferers and compare them with outcomes from saline nasal spray, the currently most popular drug-free treatment option.
“Our previous studies with controlled exposure to grass pollen and house dust mites in allergen challenge chambers already demonstrated a rapid onset and long durability of Bentrio’s protective effect in allergic rhinitis,” he added. “We expect the NASAR study to reinforce and complement these earlier findings, with its data read-out anticipated in the first quarter of 2023.”
About Bentrio
Bentrio is an OTC drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of allergens (or virus particles) with cells; in addition, the composition serves to bind such particles and help with their discharge. Together, this is designed to promote alleviation of allergic symptoms (or mitigate upper respiratory tract viral infections). For more info, visit: https://altamiratherapeutics.com/our-products/bentrio
About Altamira Therapeutics
Altamira Therapeutics (NASDAQ:CYTO) is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne allergens and, where approved, viruses (Bentrio™; commercial) or for the treatment of vertigo (AM-125; post Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®; Phase 3). Founded in 2003, it is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' 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 approval and timing of commercialization of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' 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 Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2021, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission'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 Therapeutics or to persons acting on behalf of Altamira Therapeutics 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 Therapeutics 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.
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