16 May Lakewood-Amedex Announces Results Demonstrating The More Rapid Direct Bactericidal Activity Of Novel Bisphosphocin Class Of Antimicrobials

SARASOTA, Fla., May 16, 2013 /PRNewswire/ — Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced today that a recent series of in vitro studies have provided new evidence that its novel class of antimicrobials, named bisphosphocins, function through a completely unique mechanism of action involving bacterial membrane depolarization, resulting in rapid direct bacterial killing.  These studies expand on previously published experiments demonstrating Nu-3 to be superior to ciprofloxacin.  The studies revealed the ability of Nu-3 to generate a >5 log reduction in bacterial counts of stains such as Klebsiella pneumonia and Acinetobacter baumanii in as little as five minutes, or less time than these bacteria take to replicate.  Using the standard “post-antibiotic affect” protocol, designed to assess the delay in growth caused by traditional antibiotics, the >5 log reduction in bacterial cell counts represents the maximum value achievable in these assays due to the rapid direct killing mechanism of bisphosphocins and resulting in no bacterial growth.

This result is significant because the unique bisphosphocin mechanism of action eliminates many of the current problems in the treatment of bacterial or fungal diseases, namely the development of microbial resistance, and can eradicate slow growing or stationary bacteria and bacterial biofilms, constantly a major problem for the medical community.  Traditional antibiotics only inhibit bacterial growth, typically through a single target molecule, thus requiring a prolonged exposure that provides an opportunity for the bacteria to mutate and become resistant or dormant to avoid the antibiotic affecting them.  In the case of bisphosphocins, the effect is directly bactericidal and does not depend on the bacteria being in a growth cycle, eliminating any opportunity for the development of resistance and increasing their potency when bacteria become dormant or form a biofilm.

Lakewood-Amedex’s Vice President, Product Development, Paul DiTullio, commented “The recent studies using Nu-3 provide further confirmation of the major advantages offered by the bisphosphocin class for the treatment of bacterial and fungal infections and their potential to address several major healthcare problems.”

The Company is fast tracking the development of a topical bisphosphocin formulation specifically because its rapid bactericidal activity makes it an excellent therapeutic candidate to address several unmet medical needs for clinical indications such as acute bacterial skin infection, infected diabetic foot ulcer, ophthalmic infections, and fungal infections such as onychomycosis.  In addition, bisphosphocins exhibit an extremely broad spectrum of activity that is critical when addressing clinical indications where the infection may be polymicrobial, or with eye infections where there is no time to identify the infecting organism.  The compounds possess an excellent safety profile and are well tolerated in vivo due to their highly specific mechanism of action that exploits a critical difference between the prokaryotic membranes of bacteria/fungi and the eukaryotic membranes of mammals, including humans.

Lakewood-Amedex expects to make additional major announcements regarding the utility of the bisphosphocin family of broad-spectrum antimicrobials in the coming weeks and is actively seeking partnering opportunities for major indications using these products.

About Lakewood-Amedex, Inc.

Lakewood-Amedex is a privately held biopharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class anti-bacterial compounds, orally available nanoRNA therapeutics for acute and chronic diseases such as arthritis, inflammation, cancer, influenza, and hepatitis, and a fully human monoclonal antibody for HUS.  The Company’s products and technology are covered by an extensive patent portfolio consisting of 36 granted and/or issued patents and 29 pending patent applications filed on a worldwide basis covering all 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 expected to enter the clinic in 2013.

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.