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   ANTIMICROBIAL DRUG DEVELOPMENT

    The Center for Disease Control and Prevention (CDC) now classifies Clostridium difficile associated disease (CDAD) as an Urgent Public Health Threat. CDAD is an illness that appears most frequently within hospital and eldercare settings, and is clearly abetted by the frequent use of broad spectrum antibiotics that inevitably also destroy the normal intestinal flora. Moreover, recent emergence of new hyper-virulent CD strains (i.e., NAP1/B1/027) has increased the seriousness of CDAD and the number of deaths resulting from it. Recently, revised CDC estimates for 2011 cites approximately half a million cases, 29,000 deaths, and at least $4 billion in excess medical costs per year.

   Treatment of CD infection with antibiotics is a challenge as it should be active against CD but should do minimal damage to normal gut flora. At present, metronidazole (MET), vancomycin (VAN), and fidaxomicin (FDX, a new antibiotic) are used to treat CD infection, but these drugs suffer from high recurrence rates: 15-30 % after the first episode and 40-60% after the second episode. There is, thus, an urgent need for discovery and development of new therapies for CDI.

   KamTek has identified a number of promising compounds for the treatment of CDAD. One or more of these have a strong potential to be active against Clostridium difficile with negligible chances of inducing resistance in the target microbes. These are at various stages of development and testing.

   PRE-CLINICAL DRUG DEVELOPMENT SERVICES


   KamTek also offers the following antimicrobial drug development services to potential clients at our Gaithersburg facility:

In vitro Testing Services

o Establish and Expand Bacterial Cultures: KamTek's microbiology facility is fully equipped and set up for cultivation of any aerobic and anaerobic bacteria as well as fungal pathogens. The facility and its operations are fully geared towards biosafety following GLP practices required for pre-clinical and clinical studies.

o In vitro Testing of Antimicrobial Activity of Investigational Compounds: KamTek offers in vitro determinations of minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of investigational compounds.





    In addition, depending on the requirements, the following services are also performed: drug solubility; drug-drug interaction; protein binding; intracellular activity; post-antibiotic treatment effect; rate of killing; and, frequency of development of resistance.

o Cytotoxicity Assays of Drugs and Toxins in Mammalian Cell Culture Systems

o Preparation of Spore Stocks of Sporulating Microbes for Infecting Animal Model Systems

In vivo Testing Services

KTI has an arranged partnership with a local animal facility with decades of experience in preclinical studies using a variety of animals.

o Development of Drug Formulations for Testing Efficacy in Animal Models to Select Suitable Ones for   Clinical Trials

o Design and Manage Preclinical Efficacy Studies in Suitable Animal Models

o Testing of Drug Levels in Body Fluids and Tissues

o Microbiome Studies: Effect of Antimicrobial(s) or other Agents on Gut Microbiome


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4851 International Blvd., Suite-102, Frederick, MD - 21703
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