The most relevant points are in the Appendix pages 60,61 and 62. Antibiotic resistant bacteria are killing thousands every year resulting in billions of dollars in health care costs.
It is now a national priority to develop new antibiotics which means CTIX can expect incentives to develop its Defensin-Mimetic franchise.
From pg 10
"promote...public-private partnerships to incentivize development of new
therapeutics...including new, next- generation... antibiotics"
By 2020 ...advancement of at least two new antibiotic drug candidates, non-traditional therapeutics...to clinical trials for treatment of human disease.
GOAL 4: Accelerate Basic and Applied Research and Development for New Antibiotics, Other
Therapeutics, and Vaccines. Despite the urgent need for new antibiotics, the number of
products in the drug-development pipeline is small and commercial interest remains limited.
The advancement of drug development—as well as non-traditional therapeutics and vaccines—
will require intensified efforts to boost scientific research, attract private investment,
and facilitate clinical trials of new drug candidates. Goal 4 activities will help accomplish these
objectives by supporting basic and applied research, providing researchers with scientific
services (e.g., specimens, sequence data, and regulatory guidance), and fostering publicprivate
partnerships that strengthen the clinical trials infrastructure and reduce the risks,
uncertainty, and obstacles faced by companies who are developing new antibiotics and/or
other therapeutics and vaccines that can impact the use of antibiotics and the development
of resistance.
CTIX has reported its defensin mimetics have shown activity against a number of the most important infectious agents listed in the report:
1.Carbapenem-Resistant Enterobacteriaceae*
Out of ~140,000 healthcare-associated Enterobacteriaceae infections per year, more than 9,000 are caused by CRE (7,900
CR-Klebsiella spp; 1,400 CR-E. coli.).
Out of ~140,000 healthcare-associated Enterobacteriaceae infections per year, more than 9,000 are caused by CRE (7,900
CR-Klebsiella spp; 1,400 CR-E. coli.).
44 States have had at least one type of CRE confirmed by CDC testing.
CRE are resistant to nearly all antibiotics including carbapenems—the antibiotic of last resort.
2 Fluconazole-Resistant Candida
Out of 46,000 Candida yeast infections per year, 3,400 (30%) of patients with bloodstream infections with drug-resistant
(DR)-Candida die during their hospitalization.
CDC estimates that each case of Candida infection results in 3-13 days of additional hospitalization and a total of $6,000-
$29,000 in direct healthcare costs per patient.
3. Extended Spectrum ß-Lactamase (ESBL) Producing Enterobacteriaceae*
Extended Spectrum ß-Lactamase (ESBL) is an enzyme that allows bacteria to become resistant to a wide spectrum of
penicillins and cephalosporins.
Of 140,000 Enterobacteriaceae infections per year, 26,000 are drug resistant causing 1,700 deaths.
26,000 healthcare-associated Enterobacteriaceae infections are caused by ESBL-Enteorbacteriaceae.
26,000 healthcare-associated Enterobacteriaceae infections are caused by ESBL-Enteorbacteriaceae.
Vancomycin-Resistant Enterococcus
Of 66,000 Enterococcus infections per year, 20,000 are drug resistant causing 1,300 deaths.
Enterococcus strains resistant to vancomycin leave few or no treatment options.
Multidrug-Resistant Pseudomonas aeruginosa
Of 51,000 Pseudomonas infections per year, 6,700 are multidrug resistant causing 440 deaths.
13% of severe healthcare-associated infections caused by Pseudomonas are multidrug resistant, meaning nearly all or all
antibiotics no longer cure these infections.
4.Methicillin-Resistant Staphylococcus aureus (MRSA)*
Over 80,000 invasive MRSA infections and 11,285 related deaths per year (in 2011).
Severe MRSA infections most commonly occur during or soon after inpatient medical care.
Between 2005 and 2001, overall rates of invasive MRSA dropped 31% predominantly due to appropriate medical procedures
implemented in central-line maintenance
5.Drug-Resistant Tuberculosis* (Notifiable to CDC)
Tuberculosis is among the most common infectious diseases and cause of death worldwide.
Of 10,528 Tb cases in the U.S. in 2011, 1,042 (9.9%) were resistant to antibiotics resulting in 50 deaths.
CDC manages 5 Tb Regional Training and Medical Consultation Centers (RTMCCs) and ongoing surveillance for drugresistant
Tb in all 50 states and DC using the National Tuberculosis Surveillance System (NTSS
6.Vancomycin-Resistant Staphylococcus aureas (Notifiable to CDC)
Few cases thus far (13 cases in 4 States since 2002).
Staph a strains resistant to vancomycin leave very few or no treatment options.
