• Publication in International Archives of Allergy and Immunology
shows rapid onset and long duration of Bentrio’s protective effects
in allergic rhinitis sufferers • Mean increase of total nasal
symptom score (TNSS) 1.1 points lower vs. no protection, providing
clinically meaningful improvement • Mean increase of TNSS 0.4
points lower vs. established powder allergy blocker spray; Bentrio
efficacy rated 2x more favorably by patients • Treatment safe and
well tolerated
Altamira Therapeutics Ltd. (NASDAQ:CYTO) ("Altamira" or the
"Company"), a company dedicated to developing therapeutics that
address important unmet medical needs, today announced that the
International Archives of Allergy and Immunology (IAAI) has
published a peer-reviewed article titled, “Efficacy and safety of a
drug-free, barrier-forming nasal spray for allergic rhinitis:
randomized, open-label, crossover noninferiority trial.” The trial
showed that BentrioTM (AM-301) alleviated allergic nasal symptoms
during controlled exposure to grass pollen for four hours.
Compared to a marketed nasal spray based on
hydroxypropylmethylcellulose (HMPC) powder, Bentrio showed
non-inferiority with faster onset of action and superior global
efficacy ratings by study participants and clinicians. The
treatment was safe and well tolerated. The results from the trial
provided essential clinical data for obtaining market clearance by
the US Food and Drug Administration (FDA), which occurred in June
2022.
Bentrio is an OTC drug-free nasal spray designed for personal
protection against airborne allergens and, where approved, viruses.
It is already being distributed in several countries in Europe and
Asia and is expected to become available in progressively more
countries through a growing global network of distributors. As
previously announced, the Company is seeking to divest or
out-license Bentrio for key markets in North America and
Europe.
“We’re pleased to see details about this exciting study
published following peer review,” said Jean Lachance, Head of
Altamira Therapeutics' OTC Consumer Health Business Unit. “Bentrio
showed a persisting protective effect over the four hours of pollen
exposure, which was in line with the other tested barrier-forming
nasal spray. We were very pleased by the more rapid onset of
protection, which we believe was a major factor driving the
superior overall rating of efficacy by patients and
investigators.
“With this study we had initiated the clinical testing of
Bentrio, which since then has greatly expanded,” Mr. Lachance
added. “Earlier this year, we announced positive outcomes also
under house dust mite challenge, and our large NASAR trial with
sufferers from seasonal allergic rhinitis in Australia is
progressing towards an expected read-out in the first half of 2023.
At the same time, we are looking forward to seeing the results from
our COVAMID trial with Bentrio in acute COVID-19, which are
expected later in the current fourth quarter.”
Study Highlights
Bentrio was tested in an open-label randomized cross-over trial
at the Fraunhofer Institute for Toxicology and Experimental
Medicine (ITEM) in Hannover (Germany) in 36 patients with allergic
rhinitis to grass pollen. Subjects were first exposed to Dactylis
glomerata pollen without protection and then received protection by
Bentrio or a marketed HPMC nasal spray, which served as predicate
device in the 510(k) submission to the FDA (7 days apart). Efficacy
was assessed from total nasal symptom score (TNSS), nasal secretion
weight, and a subjective global rating. The primary endpoint was
the difference, between Bentrio and HPMC, in the least square mean
change in TNSS over a 4-hour exposure to the allergen.
Under treatment with Bentrio, participants reported a mean
increase in the Total Nasal Symptom Score (TNSS; averaged over 4
hours in 20 minute intervals) of 4.75 points, which was 1.11 points
and thus significantly below TNSS levels when exposed to pollen
without nasal spray protection (ANCOVA least square means; 95%
confidence interval, CI: -1.61 to -0.61). A 1-point reduction in
the TNSS is considered clinically relevant. 31.4% of study
participants rated the efficacy of Bentrio as “good” or “very
good”, while study investigators provided such rating for 45.7% of
participants. Under treatment with HMPC, the TNSS increased on
average by 5.14 points, which was 0.71 points lower than when
unprotected (CI: -1.21 to -0.21). 14.3% of study participants rated
the efficacy of the comparator as “good” or “very good”, while
study investigators provided such rating for 25.0% of participants.
Bentrio showed significantly lower increases in the TNSS than HPMC
during the first 40 minutes of pollen exposure. For the primary
endpoint of the study, the difference in the least-square means
between the two treatments was -0.39 (95% CI, -0.89 to 0.10) in
favor of Bentrio, establishing non-inferiority and thus substantial
equivalence to the predicate device. Sixteen subjects reported
adverse events with a relationship to AM-301 or HPMC; most adverse
events were mild, and none was serious. Overall tolerability was
rated as good or very good by over 80% of study participants for
both devices. About the International Archives of Allergy and
Immunology
International Archives of Allergy and Immunology provides a
forum for experimental and clinical research in modern molecular
and cellular allergology and immunology. Appearing monthly, the
journal publishes original work in the fields of allergy,
immunopathology, immunogenetics, immunopharmacology,
immunoendocrinology, tumor immunology, mucosal immunity,
transplantation, and immunology of infectious and connective tissue
diseases. In addition to original papers, it features short
communications, reviews, mini-reviews, commentaries, and opinions.
A team of internationally renowned and committed editors guarantees
a fair review process, high scientific quality, and fast
dissemination of significant and novel work. For more info, visit
https://www.karger.com/Journal/Home/224161
About Bentrio™Bentrio is a drug-free nasal
spray for personal protection against airborne viruses and
allergens. 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 viruses or allergens with cells;
in addition, the composition serves to bind such particles and help
with their discharge and to humidify the nasal mucosa. Together,
this is designed to reduce the risk of upper respiratory tract
viral infections and promote alleviation of allergic symptoms. For
more info, visit:
https://altamiratherapeutics.com/our-products/bentrioBentrio is
being distributed in selected European and Asian countries and is
expected to become available through distributors in further
countries in Europe, Asia and MENA. In the US, in June 2022
Altamira received FDA 510(k) clearance of Bentrio in the treatment
of allergic rhinitis.
About Altamira TherapeuticsAltamira
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 viruses and allergens (Bentrio; commercial) or for
the treatment of vertigo (AM-125; 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. For more information, visit:
https://altamiratherapeutics.com/.
Forward-looking StatementsThis 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 exercise by Zilentin AG of its option to
purchase additional legacy assets, the achievement by Altamira of
the milestones set forth in the option agreement with Zilentin,
Altamira’s ability to complete a divestiture transaction of
Bentrio, 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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