Ximycin is the first product ever to feature the combination of two potent well-established and accepted agents using a breakthrough delivery method allowing extended polymicrobial coverage at the site of the wound. It is intended for use as a prophylaxis therapy for the mitigation or prevention of multi-drug resistant surgical site infections (SSI), including multi-drug resistant Gram-negative and/or Gram-positive infections.
In the Phase 2b clinical trial of Ximycin therapy for the prophylaxis of IBD/colorectal surgery, a single dose of Ximycin administered directly into the surgical wound demonstrated favorable safety and tolerability profiles with a statistically significant reduction in SSI’s vs. the standard of care control arm. Patients who received Ximycin experienced a 65% reduction in SSI’s including those caused by multi-drug resistant Gram-negative and Gram-positive pathogens. In in vitro experiments, Ximycin, has demonstrated the ability to cover a wide variety of multi-drug resistant Gram-negative, Gram-positive, and atypical bacteria, including multi-drug resistant Klebsiella pneumoniae, the species of Gram-negative bacteria that killed seven patients at the Clinical Center of the National Institutes of Health in 2012. Multi-drug resistant Klebsiella pneumoniae is one of the carbapenem-resistant Enterobacteriaceae listed as an urgent threat by the Centers for Disease Control and Prevention, or CDC, in a September 2013 report. Gram-negative bacteria that are resistant to all available antibiotics are increasingly common and a growing threat to public health.
We believe the potential of Ximycin to cover multi-drug resistant Gram-negative bacteria, as well as multi-drug resistant Gram-positive, and atypical bacteria, and its potential for topical (non-systemic) therapy, will enable Ximycin to become the therapy of choice for first-line prophylactic topical treatment in a wide variety of serious and life-threatening infections that occur at surgical sites
We are also focused on developing and commercializing a first-of-its-kind chemical platform directed to peracid technology and acquiring other synergistic technologies/products.
This chemical family has applicability for treating infections as well as providing other positive tissue effects. The peracid technology is fundamentally non-toxic at clinically relevant doses and has demonstrated broad-spectrum efficacy against all major classes of pathogens.
The first active agent from our platform technology, VERIOX™, has undergone significant pre-clinical efficacy and safety testing. Using VERIOX™ as our first-generation active agent, we intend VERIOX™ to target areas that are underserved in terms of new technology and clinical outcomes in the orthopedics, wound and surgical spaces.
We are pursuing three VERIOX™-containing medical products for uses in the wound, orthopedic and dermatology markets. Simultaneously with our product development efforts, we are beginning to develop the product manufacturing and commercialization infrastructure to bring our technology to market and to partner with other companies to bring value to their product lines.