Altamira Therapeutics Receives Approval to Commence Clinical Trial Evaluating Bentrio in the Treatment of COVID-19

Rhea-AI Summary

Altamira Therapeutics (NASDAQ:CYTO) has received approval to initiate the COVAMID clinical trial evaluating Bentrio™ as a treatment for COVID-19. The study will involve 136 confirmed cases, randomized into groups receiving Bentrio™, placebo, or no treatment, over a 10-day period. Based on interim analysis, participants may increase to 180. Bentrio™ aims to reduce SARS-CoV-2 viral load and alleviate symptoms. Earlier studies indicated over a 99% viral load reduction with Bentrio™. The trial will begin in Bulgaria, with potential expansion to two other countries.

Positive

• Initiation of COVAMID trial for Bentrio™ in COVID-19 patients.
• Potential to enroll up to 180 participants based on interim analysis.
• Previous studies showed over a 99% reduction in SARS-CoV-2 viral load.

Negative

• None.

HAMILTON, BERMUDA / ACCESSWIRE / March 9, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that its affiliate, Altamira Medica, has received the necessary approvals to initiate a clinical investigation of Bentrio™ in COVID-19 patients (the "COVAMID" study).

COVAMID is a randomized, placebo controlled clinical trial to evaluate the ability of Bentrio™ nasal spray to reduce the SARS-CoV-2 viral load in the nose, alleviate COVID-19 signs and symptoms, and decrease the frequency of COVID-19 related hospital admissions. In the COVAMID trial, 136 confirmed (via a positive PCR test) COVID-19 patients will be randomized at a 2:1:1 ratio to receive for 10 days either Bentrio™, a placebo (Bentrio™ minus its key mineral component), or no treatment, followed by a 10-day observation phase. Based on a planned blinded interim analysis, the number of participants may be increased to a maximum of 180 COVID-19 patients. The COVAMID study will start immediately in Bulgaria, and pending further approvals, it may be extended to two additional countries.

"After demonstrating Bentrio's safety and efficacy in helping to protect patients against airborne allergens, we are excited to start the clinical assessment of our innovative nasal spray also in airborne viral infections," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Multiple in vitro studies of Bentrio using human nasal epithelia cells infected with the SARS-CoV-2 virus or the H1N1 virus have demonstrated a significant reduction of the viral titer with either prophylactic or therapeutic application. We now look forward to testing Bentrio in the treatment of COVID-19 under clinical conditions to evaluate and confirm the effectiveness of its triple mode of action, which comprises the formation of a protective film on the nasal mucosa, the trapping of virus particles and the humidification of the mucosa."

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, timing of commercialization and commercial success 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

View source version on accesswire.com:
https://www.accesswire.com/692217/Altamira-Therapeutics-Receives-Approval-to-Commence-Clinical-Trial-Evaluating-Bentrio-in-the-Treatment-of-COVID-19

FAQ

What is the COVAMID study about for Altamira Therapeutics (CYTO)?

The COVAMID study investigates the efficacy of Bentrio™ in reducing SARS-CoV-2 viral load and alleviating COVID-19 symptoms.

When does the COVAMID clinical trial for Bentrio™ start?

The COVAMID trial is set to begin immediately in Bulgaria.

What are the key findings from previous studies on Bentrio™?

Previous studies indicated that Bentrio™ could achieve over a 99% reduction in viral load in human nasal cells infected with SARS-CoV-2.

How many patients will participate in the COVAMID trial?

The trial will initially involve 136 patients, with a possibility of increasing to 180.

What is the main goal of the COVAMID study for Bentrio™?

The goal is to evaluate Bentrio™'s effectiveness in reducing COVID-19 symptoms and preventing hospital admissions.