Altamira Therapeutics Announces Publication of Positive Results from Clinical Trial with Bentrio in House Dust Mite Allergy in Leading Peer Reviewed Journal
17 Julio 2023 - 7:47AM
-Detailed results from house dust mite trial published in Clinical
and Translational Allergy-Study demonstrates statistically
significant alleviation of nasal symptoms of allergic rhinitis
Altamira Therapeutics Ltd. ("Altamira" or the "Company")
(Nasdaq: CYTO), a company dedicated to developing therapeutics that
address important unmet medical needs, today announced the
publication of the detailed results from its clinical trial with
Bentrio® nasal spray in house dust mite (“HDM”) allergic rhinitis.
The peer-reviewed article was published in Clinical and
Translational Allergy, one of the leading journals in the field of
allergology.
The HDM trial enrolled 37 patients in Canada with a history of
perennial allergic rhinitis ("PAR") who underwent controlled
allergen exposure three times in a challenge chamber for three
hours each. They were randomly assigned in an open label crossover
design to receive either Bentrio in a single or double dose, or no
treatment, prior to allergen exposure.
The primary endpoint was the change in the Total Nasal Symptom
Score (TNSS; determined in 20-minute intervals) from baseline. The
ANCOVA (analysis of covariance) model demonstrated that Bentrio
treatment reduced the increase in mean TNSS during the 3-hour
exposure by 1.1 points (-1.87 to -0.28 in the 95% confidence
interval; p<0.01) vs. no treatment. Under Bentrio treatment, the
mean TNSS was 4.1 points vs. 5.2 points under no treatment.
Administering two sprays rather than one puff did not yield any
additional treatment benefits, confirming that a single application
provides ample protection. A significant majority (86%) of study
participants rated global tolerability of the treatment as good or
very good.
“The positive results from the house dust mite challenge study
nicely complement those from the grass pollen study, demonstrating
significant protective effects regardless of the type of inhaled
allergen particles,” commented Thomas Meyer, Altamira Therapeutics’
founder, Chairman and CEO. “Also, in both studies Bentrio exhibited
a lasting protective effect for several hours, reflecting its long
nasal residence time. As demonstrated in a previously published
study, Bentrio provides a protective film on the nasal mucosa for
about 3.5 hours which far exceeds the residence time of saline
nasal spray, the current standard-of-care in drug-free allergic
rhinitis management.”
About House Dust Mite Allergies
HDM allergens constitute the prime cause of respiratory
allergies (i.e. allergic rhinitis and allergic asthma), with
prevalence estimates for allergen sensitization ranging between 65
and 130 million persons in the general population worldwide, or as
much as 50% among asthmatic patients.2 In the US population
aged 6 years and older, dust mite allergens are the second most
common source of sensitization right after plant-related allergens
(20.3 and 27.1%, respectively).3 Unlike plant-related
allergens, which tend to be seasonal (e.g. pollen / hay fever),
HDMs may be present all year long. Symptoms of HDM allergies
include sneezing, a runny or stuffy nose, itching, coughing,
difficulty breathing, and chest tightness or pain.
About Altamira Therapeutics
Altamira (Nasdaq:CYTO) is dedicated to developing RNA-based
therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™
delivery platforms). The Company currently has two flagship siRNA
programs in preclinical development beyond in vivo proof of
concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid
arthritis. The versatile delivery platform is also suited for mRNA
and other types of RNA therapeutics and is planned to be leveraged
via out-licensing to pharma or biotech companies. In addition,
Altamira is in the process of divesting and/or out-licensing its
legacy assets in allergology and viral infection (Bentrio® OTC
nasal spray; commercial) and inner ear therapeutics (AM-125 nasal
spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for
tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira 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, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
statements are statements other than historical facts and may
include statements that address future operating, financial or
business performance or Altamira’s 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 success of the
continued commercialization of Bentrio and success of strategic
transactions, including licensing or partnering, with respect to
Bentrio or any other legacy assets, Altamira’s 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’s product candidates, the clinical utility
of Altamira’s product candidates, the timing or likelihood of
regulatory filings and approvals, Altamira’s intellectual
property position and Altamira’s financial position, including the
impact of any future acquisitions, dispositions, partnerships,
license transactions or changes to Altamira’s 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’s Annual Report
on Form 20-F for the year ended December 31, 2022, and in
Altamira’s other filings with the Securities Exchange Commission
(“SEC”), which are available free of charge on the SEC’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 or to persons
acting on behalf of Altamira 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 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.
Hear@altamiratherapeutics.com
800-460-0183
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