SARASOTA, Fla., Dec. 4, 2017 /PRNewswire/ -- Lakewood-Amedex, Inc., a leading developer of novel anti-infective pharmaceuticals, today announced that it will be advancing a second Bisphosphocin drug candidate, Nu-8, into preclinical IND-enabling studies following pre-IND written communications with the U.S. Food and Drug Administration (FDA). Nu-8 will be developed for the treatment of complicated urinary tract infections (cUTI), a subsection of bladder infections usually associated with a functional or anatomical abnormality of the urinary tract or in the presence of catheterization, that are currently treated with systemic orally delivered antibiotics.
Dr. Patrick O'Connor, Lakewood-Amedex's Chief Medical Officer, said, "We are very excited about the prospect of treating recurrent, recalcitrant bladder and urinary tract infections with our novel antimicrobial Nu-8. We will be using a non-systemic, localized direct infusion of Nu-8 solution into the bladder to directly treat the infection. This mode of administration means we won't be unnecessarily causing disruption to the patient's entire microbiome, as has been recently widely reported to occur when treating infections with conventional systemic antibiotic treatments. We expect this infusion of Nu-8 solution into the bladder to substantially reduce or completely eradicate the pathogenic bacterial infection, based on the pre-clinical mammalian model studies conducted to date."
Steve Parkinson, President and CEO of Lakewood-Amedex, plans to present data on the Nu-8 program along with the recently reported, positive top-line data from the Company's completed Phase 1/2a clinical trial for its lead program, topically applied Nu-3 antimicrobial, to eliminate infection and promote wound healing in patients with infected diabetic foot ulcers (DFU), at the LD MICRO Main Event on Thursday, December 7th, at 10:00 am PT. A live webcast of the presentation may be viewed at the following link.
View the live webcast of the presentation here:
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 over 100 granted and/or issued patents and 4 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).
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.
SOURCE Lakewood-Amedex, Inc.