Altamira Receives Regulatory Approval from the Ministry of Health to Expand COVAMID Trial for Bentrio in Acute COVID-19 into North Macedonia

Extending clinical study will complement the ongoing trial in Bulgaria

Reaffirms it expects to complete the study in 3Q-22 subject to sufficient COVID-19 incidence

HAMILTON, BERMUDA / ACCESSWIRE / May 5, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received regulatory approval from the North Macedonia Ministry of Health to extend the COVAMID clinical investigation of its Bentrio™ nasal spray in patients with acute COVID-19 into the Republic of North Macedonia. North Macedonia is a sovereign nation, which borders Bulgaria to the west and has a population of 2.1 million.

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.

"Extending our study into North Macedonia strengthens our ability to meet our recruitment objectives for the COVAMID trial," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "We are pleased to further expand the number of study sites in accordance with our initial plans and to increase the overall recruitment potential. Subject to sufficient COVID-19 cases, we continue to expect completion of the COVAMID trial in 3Q 2022."

Last month, the Company announced that it had reached the midpoint for enrollment in its COVAMID clinical trial. Based on a blinded interim analysis to confirm the validity of statistical assumptions, Altamira will complete enrollment at 136 or expand to up to 180 subjects.

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.