Dipexium Pharmaceuticals Announces the Issuance of a New U.S. Patent for Locilex™ U.S. Patent includes Claims on Novel Formulation and Method of Treating Skin and Wound Infections
, /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 . 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 , 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 , , , Korea, and ."
, 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 ß-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).
It is estimated that Mild Infections of Diabetic Foot Ulcers occur in approximately 1.5 million patients per year in 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 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).
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 Email: email@example.com
SOURCE Dipexium Pharmaceuticals