HAMILTON, BERMUDA / ACCESSWIRE / December 16, 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 group of patients has been randomized in a clinical trial with Bentrio™ (AM-301) in house dust mite ("HDM") allergic rhinitis. Bentrio™, a drug-free nasal spray intended for personal protection against airborne viruses and allergens, is marketed in several countries already.
The trial will enroll a total of 36 patients with a history of perennial allergic rhinitis (PAR). It is designed to evaluate the efficacy of Bentrio™ in the treatment of PAR in an environmental exposure chamber (EEC), i.e. under controlled HDM exposure. Study participants will be randomized under an open label, three-period crossover design to receive either Bentrio™ in a single or double dose or no treatment prior to HDM exposure for three hours. The primary endpoint will be the change in the Total Nasal Symptom Score (TNSS) from baseline. The trial is being conducted at a single study site in Canada.
"Following the positive outcomes from our previous controlled pollen exposure study in seasonal allergic rhinitis, we expect this new study to demonstrate Bentrio's protective effects also in perennial allergic rhinitis," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Allergic rhinitis in both its seasonal and perennial form is a very common problem worldwide. We believe that Bentrio can help to provide important relief for many allergy sufferers based on its triple mode of action, free of any drug or preservative ingredients."
Top-line results from the HDM trial are expected to become available in springtime.
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 many as 50% among asthmatic patients.1 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).2 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, chest tightness or pain.
1 Calderon et al. (2015), Respiratory allergy caused by house dust mites: What do we really know?, J Allergy Clin Immunol 136(1):38-48.
2 Salo et al. (2014), Prevalence of allergic sensitization in the United States: results from the National Health and Nutrition Examination Survey (NHANES) 2005-2006. J Allergy Clin Immunol 134(2):350-9.
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".
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.
SOURCE: Altamira Therapeutics