Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the 'Company' or 'Kalytera') today announced new proof-of-concept data demonstrating that R-107 reduces tissue damage and preserves organ function in a lethal rodent model of sepsis that resembles the circulatory shock seen with COVID-19 associated lung disease.

Kalytera announced on May 19, 2020 that it has entered into a binding Letter of Intent to acquire Salzman Group, Inc., a privately held company located in West Tisbury, MA ('Salzman Group'). Salzman Group is the owner of R-107, a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.

Data from Rodent Study are Strongly Positive

Salzman Group studied the effectiveness of R-107 in a rodent model that is very severe, and is designed to mimic life-threatening COVID-19 infection. It is characterized by a 90% mortality rate within 7 days, with development of tissue injury in the lung, kidney, pancreas, intestine, and liver. This model correlates closely with the human clinical presentation of circulatory shock and multiple organ failure, and thus has served for many decades as a key benchmark in the initial assessment of novel candidate therapeutics for treatment of human sepsis and circulatory shock.

Results from this study were strongly positive, with the active moiety of R-107 demonstrating increased survival from 10% to 90% in septic mice over a week of follow-up. This extraordinary improvement in survival was reflected in the results of blood tests and microscopy showing full tissue protection in all the organs examined, including the liver, lung, and small intestine.

The study was conducted by Professor Salvatore Cuzzocrea, President of the University of Messina, and former President of the European Shock Society. A sepsis-like syndrome was created in mice by inoculation with bacterial endotoxin, thereby producing a massive release of pro-inflammatory signaling molecules ('cytokines') such as interleukin-1 beta and tumor necrosis factor alpha, which together are able to trigger the full hemodynamic, hematologic, and immunologic manifestations typical of the lethal human circulatory shock caused by COVID-19 infection.

R-107 is a Nitric Oxide Prodrug

R-107 is a liquid prodrug of nitric oxide that can be administered by injection, unlike nitric oxide gas, which requires a special type of delivery device, and complex administration by trained respiratory therapists. When administered by injection, R-107 is slowly hydrolyzed, releasing its active moiety, R-100, which in turn steadily and slowly releases nitric oxide into the lung tissue. This depot-like action of R-107 results in a sustained delivery of nitric oxide, allowing for a smooth delivery of the active drug over several days following a single dose of R-107.

Put simply, following injection, R-107 is metabolized, and releases R-100, which in turn releases nitric oxide into the tissues of the lung. R-100 is the payload of R-107.

The Potential of Nitric Oxide in Treatment of COVID-19 Associated Lung Disease

There are currently no approved treatments for lung disease caused by the COVID-19 virus, which is a severe form of lung failure called acute respiratory distress syndrome ('ARDS'). ARDS is the leading cause of death in COVID-19.

Nitric oxide is a gas that improves blood flow in areas of the lungs that are getting air, increasing the amount of oxygen in the blood stream.1

Along with being used to treat failing lungs, nitric oxide has also been found to have antiviral properties against coronaviruses.2

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.

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