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.”
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/
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