Altamira Therapeutics Announces Randomization of First Patient in Bentrio Trial in Seasonal Allergic Rhinitis

Rhea-AI Summary

Altamira Therapeutics Ltd. (NASDAQ:CYTO) has initiated the NASAR trial, randomizing its first patient to evaluate the Bentrio™ (AM-301) nasal spray for seasonal allergic rhinitis (SAR). The trial will involve 100 patients and compare Bentrio™'s efficacy and safety against a saline spray over two weeks. Conducted during the pollen season in Australia, it aims to assess Bentrio™'s protective effects against airborne allergens. This follows positive results from earlier studies indicating rapid and durable effects against allergic rhinitis.

Positive

• Initiation of NASAR trial for Bentrio™ to evaluate its efficacy in SAR.
• Trial involves a randomized study with 100 participants, enhancing clinical credibility.
• Previous studies showed promising results for Bentrio™ in allergic rhinitis.

Negative

• None.

HAMILTON, BERMUDA / ACCESSWIRE / December 1, 2021 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced that the first patient has been randomized in its "NASAR" trial for the clinical evaluation of Bentrio™ (AM-301) in seasonal allergic rhinitis ("SAR"). Bentrio™, a drug-free nasal spray intended for personal protection against airborne viruses and allergens, is marketed in several countries already.

The NASAR trial, which will enroll a total of 100 SAR patients, is designed to compare the safety and efficacy of Bentrio™ against a saline nasal spray. Study participants will be 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 is being conducted during the current pollen season at several study sites in Australia.

"We look forward to testing Bentrio's protective effects against airborne allergens under real life conditions during pollen season in the southern hemisphere," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Our previous study with controlled pollen exposure for four hours in an allergen challenge chamber had already demonstrated a rapid onset and long durability of Bentrio's protective effect in allergic rhinitis. We expect the NASAR study to reinforce and complement these earlier findings."

About Bentrio™

Bentrio™ (AM-301) is a drug-free nasal spray intended 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.

About Altamira Therapeutics

Altamira Therapeutics 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). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO".

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 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, 2020, 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.

Investor contact:
Stephen Kilmer
646.274.3580
sjk@altamiratherapeutics.com

SOURCE: Altamira Therapeutics

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FAQ

What is the NASAR trial related to CYTO?

The NASAR trial is a clinical study to evaluate the efficacy and safety of Bentrio™ (AM-301) in patients with seasonal allergic rhinitis.

How many patients are enrolled in the NASAR trial?

The NASAR trial aims to enroll a total of 100 patients.

What does Bentrio™ do?

Bentrio™ is a drug-free nasal spray designed to protect against airborne viruses and allergens.

Where is the NASAR trial being conducted?

The NASAR trial is being conducted in Australia during the pollen season.

What were the results of previous studies on Bentrio™?

Previous studies demonstrated a rapid onset and long durability of Bentrio™'s protective effect against allergic rhinitis.