NEW YORK, Sept. 10, 2013 /PRNewswire/ -- Dipexium Pharmaceuticals, LLC today announced modifications made to the Locilex™ (pexiganan acetate cream 1%) formulation have resulted in favorable chemical and physical stability as noted in 18-month stability testing by its manufacturer. Stability Trend Analyses at 18 months suggest a Locilex™ shelf-life of at least 36 months at room temperature. In addition, successful testing of this commercial-scale batch of non-cGMP material, in the to-be-marketed commercial packaging, utilizes a highly-purified active pharmaceutical ingredient (API), pexiganan acetate, at levels markedly above the purity level in the original formulation used by the prior sponsor of the Locilex™ development program. As previously reported, the United States Patent and Trade Office issued a notice of allowance for a new formulation and method of use patent on this novel Locilex™ formulation in June 2013.
"Evidenced by the manufacturing challenges faced by the prior sponsor of Locilex™, formulating a topical peptide is a complex process. We are extremely pleased that our novel Locilex™ formulation has addressed these challenges, resulting in vastly improved physical stability of the product," stated Robert J. DeLuccia co-Managing Partner of Dipexium. Mr. DeLuccia continued, "The impurity profile noted in the API used to formulate Locilex is now well within what could be considered acceptable standards."
"With the successful completion of our Locilex™ manufacturing and formulation modifications and the FDA's issuance of a Special Protocol Assessment Agreement for our proposed placebo-controlled, pivotal Phase 3 trial (Protocol DPX-305) in Mild Infections of Diabetic Foot Ulcers, we are now well positioned to move forward along our clearly defined regulatory pathway for our planned pivotal Phase 3 clinical program," stated David P. Luci, co-Managing Partner of Dipexium.
Dipexium plans to submit a CMC (Chemistry, Manufacturing & Controls) update to FDA and initiate patient enrollment in pivotal Phase 3 Study DPX-305 in the fourth quarter of this year.
Phase 3 Study Design
Study DPX-305 will be a randomized, double-blind, multi-center, superiority, placebo-controlled Phase 3 Study of Pexiganan Acetate Cream 1% (Locilex™) applied twice daily for 14 days to treat adult patients with mild infections of diabetic foot ulcers in the United States. Study DPX-305 will involve approximately 180 patients and the primary efficacy endpoint is resolution of infection in the medical judgment of each treating physician in accordance with the standardized guidance set forth in the 2012 Infectious Disease Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (the "DFI Treatment Guidelines"). The DFI Treatment Guidelines were published in the June 15, 2012 edition of Clinical Infectious Disease and is available on our website at www.dipexiumpharmaceuticals.com.
About Special Protocol Assessments
The SPA process is a procedure by which the FDA provides official evaluation and agreement on the design and size of proposed protocols that are intended to form the basis for a Biologics License Application ("BLA") or New Drug Application ("NDA"). Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial as well as, in our case, the results of Study DPX-306, an identical Phase 3 study intended to be conducted simultaneously with Study DPX-305.
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), vancomycin-resistant enterococcus (VRE), extended-spectrum Beta-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.
If FDA approved, Locilex™ could become the first topical antibiotic approved for the treatment of diabetic foot infection of any severity (mild, moderate or severe DFI) and the first prescription drug approved for patients with mild DFI.
About Mild Infections of Diabetic Foot Ulcers
It is estimated that Diabetic Foot Infections occur in approximately 1.3 million patients per year in the United States and approximately one-half of the patients first present with mild 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 and is estimated to continue growing through at least 2019. 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 safely and toxicity issues needlessly if a topical, non-invasive yet effective antibiotic were to be approved and become a viable treatment option available for treating physicians. Accordingly, we believe Locilex™ may constitute a significant therapeutic advance in the treatment of Mild Infections of Diabetic Foot Ulcers.
Founded in January 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 microbiology data, Locilex™ is also considered a promising product candidate, to treat 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 research and development 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 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