Lakewood-Amedex Advances Novel Bisphosphocin® Nu-8 Compound Based on Encouraging Pre-Clinical Results

Company Secures $2.9 Million to Support IND-Enabling Studies

SARASOTA, Fla., April 4, 2017 /PRNewswire/ — Lakewood-Amedex Inc., a clinical stage pharmaceutical company developing novel anti-infectives, announced today that it is advancing its second bisphosphocin candidate toward clinical development in 2017. The Company reported new in vitro data confirming the unique mechanism of action of its proprietary Bisphosphocin® class of antimicrobial compounds, as well as the greater potency of its Nu-8 compound against clinically pathogenic bacteria under conditions that make its suitable as a therapy for specific localized treatment of infections in certain organs. The results further support advancing Nu-8 as the Company’s second lead pipeline asset and its first candidate targeted to non-topical applications. The Company also announced that it successfully raised $2.9 million in a private placement, some of which will be used to fund IND-enabling pre-clinical studies for Nu-8, with an initial target indication of catheter-acquired urinary tract infection (CAUTI).

Lakewood-Amedex’s proprietary Bisphosphocins have demonstrated remarkably broad-spectrum activity against bacteria, yeast and certain fungi with no obvious toxicity and no known development of microbial resistance. The latest bacterial cytological profiling studies further demonstrate the rapid activity and the dramatic effect on cell membrane permeability, which appears to be the primary bactericidal mechanism. In these studies, Nu-8 was highly active against strains of E. coli and P. aeruginosa, collectively responsible for the majority of CAUTI and recurrent bladder infections. This compound showed a markedly rapid and dramatic effect on bacterial cell permeability and viability, whereby no viable E. coli cells were detected after four hours of treatment with Nu-8 even at the lowest concentration tested. Nu-8 was even more active against P. aeruginosa, working within minutes to significantly reduce bacterial viability at higher concentrations.

“In this time of overwhelming antibiotic resistance for many prevalent and potentially life-threatening bacterial infections, Lakewood-Amedex is proud to be answering the CDC’s call for novel antimicrobials,” said Steve Parkinson, President and CEO of Lakewood-Amedex. “E. coli infection is one of the primary causes of CAUTI and P. aeruginosa is one of the top six clinically relevant bacteria with rising antibiotic resistance, included in the ‘ESKAPE pathogen’ list. Our new data indicate Nu-8 has unique characteristics making it an ideal candidate to treat infections such as CAUTI, where its potent activity suggests it will be highly effective following intra-bladder administration. We are excited and prepared to move into IND-enabling toxicology and in vivo efficacy studies as well as cGMP manufacturing of the drug substance and drug product in order to file an investigational new drug (IND) application as soon as possible.”

Mr. Parkinson concluded, “Advancing Nu-8 toward this clinical treatment expands the application of bisphosphocins to more critical pharmaceutical indications and adds value to our pipeline. This distinct therapeutic candidate compliments our lead clinical-stage bisphosphocin, Nu-3, for which we are currently completing a Phase 1/2a trial as a topical solution for treating infected diabetic foot ulcers (iDFU), with top-line data anticipated in the second quarter 2017.”

About Lakewood-Amedex, Inc.

Lakewood-Amedex is a clinical stage pharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class anti-bacterial compounds. The Company’s products and technology are covered by an extensive patent portfolio consisting of 74 granted and/or issued patents and 13 pending patent applications covering many major pharmaceutical markets. The Company’s lead therapeutic candidate is a novel synthetic broad spectrum anti-bacterial proven to be effective in killing a wide range of gram-positive, gram-negative and antibiotic-resistant bacteria and is currently in Phase 1/2a clinical trials.

Forward-Looking Statements

This press release contains forward-looking statements that can be identified by terminology such as “expects”, “potential”, “suggests”, “may”, “will” or similar expressions. Such forward-looking statements regarding our business, which are not historical facts, are “forward-looking statements” that involve risk and uncertainties, which could cause the Company’s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. Actual results may differ materially from statements made as a result of various factors, including, but not limited to sufficiency of cash to fund the Company’s planned operations, risk associated with inherent uncertainty of product research and development, risk of protecting proprietary rights and competition. Forward-looking statements speak only as to the date they are made. The Company does not undertake to update forward-looking statements to reflect the circumstances or events that occur after the date the forward-looking statements are made.

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Joshua Drumm, Ph.D. (investors)
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Andrew Mielach (media)
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