NEW YORK, July 9, 2013 /PRNewswire/ -- Dipexium Pharmaceuticals, LLC today announced it received a notice of allowance from the U.S. Patent and Trademark Office for a patent covering both a novel formulation of Locilex™ (pexiganan acetate cream 1%), an antibiotic peptide formulated as a topical cream, and the use of Locilex™ as a method of treating skin or wound infections. Dipexium currently is preparing for initiation of a Phase 3 trial of Locilex™ in mild infections of diabetic foot ulcers, which will be conducted under an existing Special Protocol Assessment agreement with the U.S. Food and Drug Administration with initiation of enrollment targeted for the second half of 2013. The patent to be issued from this allowed application carries an expected 20 year patent term to June 2032. Dipexium has also filed an application under the Patent Cooperation Treaty which could extend the patent protections of this new patent to up to 120 countries throughout the world.
"This new patent allowance is important to Dipexium for two reasons," stated David P. Luci, Co-Managing Partner of Dipexium, "First, it extends Locilex's™ patent life in the U.S. well beyond the currently issued patent and anticipated regulatory exclusivity periods. Second, we expect our PCT filing based on the allowed U.S application to eventually help us expand into major international markets such as Japan, China, Australia, Korea, Latin America and South America."
Robert DeLuccia, Co-Managing Partner of Dipexium, commented, "Currently, there are no FDA approved therapies for the treatment of mild infections of diabetic foot ulcers and there are no topical products approved or recommended for any severity of diabetic foot infections. We believe this soon to be issued formulation and method of use patent further validates the unique properties of Locilex™ relative to systemic treatments available to diabetics with infected foot ulcers as well as patients with other acute bacterial skin infections."
Locilex™ (pexiganan acetate cream 1%) is a broad spectrum, topical antimicrobial peptide which is chemically synthesized from the skin of the African clawed frog. Locilex™ has a novel, bactericidal mechanism of action uncommon among antibiotics currently marketed, which generally inhibit pathogen growth. Locilex™ (positively charged) forms an alpha helix and disrupts the lipid bilayer of the bacterial cell wall (negatively charged) thereby creating an opening into which intracellular fluid, extracellular fluid and water enter, effectively lysing the bacterial cell.
Locilex™ has been used successfully in Phase 3 clinical studies demonstrating significant clinical benefit in patients with mild or moderate diabetic foot infections. Dipexium has supported the Locilex™ clinical database recently by conducting microbiology studies that highlight the sensitivity of resistant bacteria to Locilex™, including methicillin-resistant Staphylococcus aureus (MRSA), vancomyn-resistant enterococcus (VRE), extended-spectrum β-lactamase (ESBL) and multi-drug resistant (MDR) bacteria. Because of the increased prevalence throughout the world of multi-drug-resistant bacteria and XDR bacteria in all types of bacterial skin infections, Locilex™ may provide an important therapeutic advance.
In clinical trials, no safety concerns have been reported in over 1,000 human subjects exposed to Locilex™. Importantly, no antimicrobial resistance, or cross resistance with other antibiotics, has been noted to date. Because Locilex™ does not absorb beneath the subdermal layer of the skin, systemic resistance to the drug cannot develop, unlike virtually all other currently available antibiotics.
Locilex™ has the potential to become the first topical antibiotic approved for the treatment of diabetic foot infection of any severity (mild, moderate or severe DFI).
About Mild Infections of Diabetic Foot Ulcers
It is estimated that Mild Infections of Diabetic Foot Ulcers occur in approximately 1.5 million patients per year in the United States and constitute approximately one-half of the patients who first present with mild, moderate or severe Diabetic Foot Infection each year. The worldwide market for Diabetic Foot Infection (mild, moderate and severe DFI) is estimated at approximately $1.5 billion in 2011 with the incidence expected to continue growing. Currently, there are no antibiotics, systemic or topical, which are FDA approved for the treatment of Mild Infections of Diabetic Foot Ulcers. We believe currently used antibiotics for this indication are either overly invasive for the infection being treated, cause systemic resistance and generate resistant bacteria or involve safety and toxicity issues needlessly if a topical, non-invasive yet effective antibiotic were to be approved and become a standard of treatment available to physicians treating mild infections of diabetic foot ulcers. Accordingly, we believe Locilex™ may constitute a significant therapeutic advance in the treatment of Mild Infections of Diabetic Foot Ulcers.
Founded in 2010, Dipexium Pharmaceuticals, LLC is an emerging biotechnology company formed to develop and commercialize Locilex™ (pexiganan acetate cream 1%), a novel, broad spectrum, small peptide topical antibiotic for the treatment of certain mild and moderate skin infections in superficial wounds. Initially, Locilex™ is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and pre-clinical data, Locilex™ is also considered a promising product candidate, to treat mild or moderate acute bacterial skin and skin structure infections (ABSSSI) in superficial wounds, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1, Phase 2 and/or Phase 3 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult their financial, legal and other professional advisors for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
For additional information about Dipexium Pharmaceuticals or Locilex™, please visit: www.dipexiumpharmaceuticals.com or contact the Company as follows:
David P. Luci
Co-Founder & Managing Partner
Tel: (917) 533-1469
SOURCE Dipexium Pharmaceuticals