Altamira Therapeutics Continue Bentrio Clinical Trial for Seasonal Allergic Rhinitis in Australia
03 Octubre 2022 - 7:47AM
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/
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