Lakewood-Amedex Receives Notice of Allowance for Two U.S. Patents Covering the Broad-Spectrum Antimicrobial Nu-8 Bisphosphocin®

• U.S. Patent and Trademark Office Satisfied Patent Applications Meet All Requirements
• Lakewood-Amedex Plans to Advance Clinical Programs for Nu-8 in Lung and Bladder Infections

SARASOTA, Fla., May 27, 2020 /PRNewswire/ -- Lakewood-Amedex Inc. (the "Company"), a clinical-stage developer of revolutionary antimicrobial Bisphosphocins® pharmaceuticals for rapid localized treatment of serious antibiotic-resistant infections, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a "Notice of Allowance" for two broad patent applications related to the Company's broad-spectrum antimicrobial Nu-8 Bisphosphocin compound, titled "Antimicrobial Compounds, Compositions, and Uses Thereof." The "Notice of Allowance" indicates that the USPTO is satisfied that the patent applications meet all USPTO requirements.

U.S. Patent Application Serial No 16/505,497 encompasses the Nu-8 compound and pharmaceutical compositions containing Nu-8. U.S. Patent Application Serial No. 16/505,501 encompasses a method of treating bladder infections by administering Nu-8.

Nu-8 belongs to a proprietary class of novel antimicrobial agents, Bisphosphocins, that can be used to treat infections, including those caused by antibiotic-resistant bacteria, of the skin, lungs, bladder and other tissues directly at the infection site where it actively depolarizes the bacterial cell membranes, causing rapid bacterial cell death while being totally harmless to mammalian cells. This facilitates rapid eradication of the pathogens, often with a single treatment, while avoiding potential damage to the patient's gastro-intestinal microbiome that may result in adverse health issues.

Nu-8 has shown compelling results in animal safety and efficacy studies. Model disease studies have demonstrated a single 20-minute infusion of Nu-8 solution into the bladders of rodents was sufficient to eradicate an antibiotic-resistant E. coli infection. Lakewood-Amedex plans to initiate a placebo-controlled, dose-escalating, Phase 1/2a bacteriuria clinical trial to eradicate bacteria from patients' bladders. The Company also plans to initiate a Phase 1 clinical trial evaluating the safety and tolerability of an aerosolized Nu-8 solution when inhaled into patients' lungs.

Steve Parkinson, President and CEO of Lakewood-Amedex, commented, "Allowance of the broad Nu-8 compound patent application is an important development for us. We intend to use Nu-8 for all clinical indications other than chronic diabetic foot ulcers (cDFU) which will use Nu-3 gel in the next clinical trial. We believe the fast and efficient killing of bacteria, yeast and fungi we have observed from our Bisphosphocins makes them well suited to treat patients with Catheter Associated Urinary Tract Infections (CAUTI). Treatment of patients with recurrent, recalcitrant bladder infections often requires hospitalization and intravenous antibiotic infusions for many days to eradicate these severe antibiotic-resistant infections. Alternatively, a 20-minute infusion of Nu-8 in a doctor's office may offer a much needed out-patient alternative and allow patients to avoid hospitalization."

Mr. Parkinson continued, "But we also see enormous potential for Nu-8 in other indications. We are planning to initiate a clinical program using aerosolized Nu-8 solution as a direct-to-lung treatment for severe bacterial and fungal lung infections. An earlier animal model demonstrated that a single one-hour inhaled Bisphosphocin treatment was enough to eradicate a severe Pseudomonas aeruginosa lung infection. We believe advancing this program is especially pertinent under the current circumstances of the COVID-19 pandemic. While we are uncertain whether Nu-8 might be directly effective against the SARS-CoV-2 virus, we do know it has been effective in treating bacterial lung infections in animal models. There has been an emergence of news stories recently indicating many human deaths attributed to COVID-19 may have been complicated by secondary bacterial lung infections resulting in the death of patients. We plan to advance Nu-8 aerosolized direct-to-lung compound to be ready for future pandemics of this nature."

About Lakewood-Amedex, Inc.

Lakewood-Amedex is a clinical stage pharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class antimicrobial compounds. The Company's products and technology are covered by an extensive patent portfolio consisting of granted and/or issued patents and pending patent applications covering many major pharmaceutical markets. The Company's lead therapeutic candidate is a novel synthetic broad-spectrum antimicrobial proven to be effective in killing a wide range of Gram-positive, Gram-negative and antibiotic-resistant bacteria and has recently completed a Phase 1/2a clinical trial in patients with infected diabetic foot ulcers (iDFU).

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SOURCE Lakewood-Amedex Inc.