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Altamira Therapeutics Provides Update on Bentrio Program

Wednesday, 29 December 2021 09:15 AM

Altamira Therapeutics

  • Bentrio™ becoming available through Amazon platform in key German market
  • Definite Marketing and Distribution Agreement signed for six Asian countries
  • Preparations for COVID-19 trial advancing
  • Company to also test effectiveness against Omicron variant

HAMILTON, BERMUDA / ACCESSWIRE / December 29, 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 provided a business update on Bentrio™, its nasal spray for protection against airborne viruses and allergens.

  • European roll-out: Since November, the Company has set up contracts with wholesalers in its lead market Germany, covering >50% of German pharmacies. Sales through these "brick and mortar" pharmacies, which still represent the vast majority of the OTC market in Germany, have since been increasing steadily and are expected to be boosted further through various marketing initiatives planned for Q1 2022. Bentrio™ has now also become available in Germany on the Amazon platform, further strengthening the product's online channel presence. The Amazon platform will be expanded to other European markets, shortly. In Switzerland, Bentrio™ will become available in early January under a distribution agreement with Akos Santé.
  • 510(k) submission in United States: The U.S. Food and Drug Administration ("FDA") started the substantive review of the Company's 510(k) application for premarket clearance for protection against airborne allergens in mid-October. As part of the review process, the Company has been in dialogue with the Agency and is looking forward to continuing working with it, aiming to make Bentrio™ available to people suffering from allergic rhinitis also in the U.S.
  • International distribution: The Company and Wellesta Holdings Pte Ltd, Singapore, entered today into a definite marketing and distribution agreement for six Asian countries - India, Indonesia, Malaysia, Singapore, Taiwan and Vietnam. A Letter of Understanding had been signed between the two companies in October, under which Wellesta has since obtained the first of the national registrations for Bentrio™ in their sales territory. Based on various ongoing discussions, the Company expects to expand the geographic footprint for Bentrio™ further through agreements with additional international distributors.
  • Omicron variant: Following successful testing of Bentrio™ against the Delta variant of SARS-CoV-2 in a human nasal epithelia model, the Company is now planning to also evaluate the product's effectiveness against the Omicron variant. Given the broad applicability of Bentrio™, the Company expects to observe protective effects in this assay also against this new and fast-spreading variant.
  • Clinical trial in COVID-19: Preparations for the conduct of a clinical trial to further confirm the efficacy and safety of Bentrio™ are progressing. Following formal classification of Bentrio™ as a medical device, the trial application is now going through the regular approval process with the Drugs Controller General of India. Meanwhile, the Company has decided to broaden the geographic scope of the study and include two countries in Southeast Europe for which trial applications will be submitted shortly under "fast track" conditions.
  • Clinical trials in allergy: In recent weeks, two clinical trials with Bentrio™ started enrolling patients suffering from allergies due to airborne allergens. In the "NASAR" trial, the Company plans to enroll 100 patients suffering from seasonal allergic rhinitis for a two-week treatment course, and in the second trial, 36 patients suffering from perennial allergic rhinitis due to house dust mite exposure. Results from the studies are expected in the first half of 2022.

"We are pleased to report further progress with the international roll-out of Bentrio, as well as with the further preclinical and clinical evaluation of Bentrio's protective effects against airborne viruses and allergens," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The rapid and global spread of the Omicron variant of SARS-CoV-2 is highlighting once more the need for simple, yet versatile protective measures to complement classic approaches such as vaccination, protective mask wearing or social distancing."

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. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio™ was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.

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 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: 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
(647) 872-4849
[email protected]

SOURCE: Altamira Therapeutics Ltd.

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