Altamira Therapeutics Reaches Midpoint for Enrollment in Clinical Trial with Bentrio in Seasonal Allergic Rhinitis in Australia
Altamira Therapeutics Ltd. (NASDAQ:CYTO) announced progress in its clinical trial for Bentrio, reaching the midpoint of 50 patients enrolled in the NASAR trial for Seasonal Allergic Rhinitis (SAR). An interim analysis confirmed the target enrollment of 100 patients, with completion expected by early January 2023.
The trial compares Bentrio's efficacy against saline nasal spray, aiming to measure the reflective Total Nasal Symptom Score. Top-line data is anticipated in late Q1 2023, highlighting the potential of Bentrio as a drug-free treatment for allergic rhinitis.
- Midpoint of enrollment reached with 50 patients in the NASAR trial.
- Interim analysis confirms target enrollment of 100 patients.
- Completion of enrollment expected by early January 2023.
- Potential to demonstrate Bentrio's superior efficacy against saline nasal sprays.
- None.
- Swift progress of study enrollment - midpoint of 50 patients reached
- Interim analysis confirmed target enrollment of 100 patients
- Completion of enrollment expected by early January 2023
HAMILTON, BERMUDA / ACCESSWIRE / December 2, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has reached the midpoint for enrollment in its "NASAR" clinical trial with Bentrio in Season Allergic Rhinitis (SAR). Based on the accumulated data from the first 53 participants, an interim analysis confirmed the enrollment target of 100 patients for appropriate statistical powering of the study.
The randomized controlled NASAR trial 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 saline spray 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 saline spray. The NASAR trial was initiated in fall of 2021 and resumed enrollment in September 2022 with the start of the new pollen season in Australia. Based on current enrollment rates, Altamira expects to complete enrollment by early January 2023 and obtain top-line data in late Q1 2023.
"With the annual pollen season in Australia in full swing, we are pleased to see enrollment into the NASAR study progressing swiftly," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The NASAR study will allow for a head-to-head comparison of Bentrio with saline nasal sprays, which are currently the most popular drug-free treatment for allergic rhinitis. We are very confident to show superior efficacy of Bentrio thanks to its triple mode of action and long nasal residence time."
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 closing of the initial sale of Zilentin, the exercise by Zilentin of its option to purchase additional legacy assets, the achievement by Altamira of the milestones set forth in the option agreement, Altamira's ability to complete a divestiture transaction of Bentrio, 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' Report on Form 6-K for the six months ended June 30, 2022, 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.
CONTACT
Investors@altamiratherapeutics.com
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SOURCE: Altamira Therapeutics
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FAQ
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