The partnership between the two life sciences companies allows a pharmaceutical or biotech company investigating new drug candidates or existing products the ability to have their compounds dosed in rodent models in about seven days after the first client meeting. “Our resources and processes are built around speed because clients need their data quicker to make their decisions which also provides cost efficiencies,” said PreClinOmics Chairman and CEO Joe Pesek.

To understand drug disposition, new methods must also be developed to track the drug in biological fluids, and AIT Bioscience provides complementary expertise in mass spectrometry to create the assay procedures. AIT Bioscience was built as the first paperless laboratory in the industry, enabling QA’d data delivery in 10 business days or less, a much shorter timeframe than the typical data delivery of one to two months. “Our two companies provide an unmatched convenience to a customer due to the fact we are located about a mile from each other, we have complementary expertise, and we can work concurrently rather than serially to save the customer time. A client can visit both companies in the same day,” said AIT Bioscience Executive Director Ronald Shoup, Ph.D.

As a result of their expertise and collaboration, the two companies are able to provide a client with an earlier impression as to whether their compound is being absorbed and distributed as expected. “A customer may have only worked with their compound in chemical tests which would give them no idea as to the absorption rate of the drug or if it is reaching its intended target,” said Shoup. “PreClinOmics is able to design the experiments and offer consultation on the study design, while AIT Bioscience works on the kind of analyses that must be done.”

In September, AIT Bioscience opened a new 18,000 square foot state-of-the-art laboratory built for both small molecule and protein bioanalysis. PreClinOmics has more than 20 years of experience in live phase research and develops models that are genetically selected for specific characteristics. The company also holds an AAALAC accreditation that relates to animal care and facility quality and is supported by AALAS-certified technicians.

“Bringing the two companies together not only demonstrates the strength of the life sciences in Indiana but also shows customers a spirit of collaboration that can provide the expertise and value they may be looking for in this challenging economy,” added Pesek.

About AIT Bioscience:

AIT Bioscience, LLC, headquartered in Indianapolis, Ind., is a bioanalytical contract research organization supporting pre-clinical and phase I-III clinical trials. AIT Bioscience provides robust analytical methods, painless sample logistics, and rapid sample analyses that support programs through to the investigational new drug and new drug applications. AIT Bioscience has created a new standard for quantitative bioanalytical analysis and drug development in support of small biotech and large pharmaceutical companies. Learn more about AIT Bioscience at www.AITBioscience.com.

About PreClinOmics:

PreClinOmics, Inc., Indianapolis, Ind. is an established preclinical contract research company primarily focused in supporting drug discovery and development research in the therapeutic areas of metabolic syndrome, its related complications and polycystic kidney disease. Incorporated in 2001, the Company is AAALAC accredited and has extensive technical and analytical capabilities to support PK/PD, screening and efficacy studies and related analysis. Learn more about PreClinOmics at www.preclinomics.com.

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Indianapolis, IN – A new rat model, the ZDSD has been developed as the next generation translational model of obesity, metabolic syndrome and related complications, under the direction of Richard G. Peterson, PhD (developer of the “Gold Standard” ZDF rat) and EVP of Research and Development at PreClinOmics.

Currently >30 generations inbred and set in its phenotypic expression, the ZDSD rat is commercially available from PreClinOmics. The primary potential use of the ZDSD rat will be as a “pre-diabetic” model in the areas of drug discovery and development to demonstrate therapeutic efficacy to stay or reverse metabolic syndrome, the precursor to type II diabetes. The ZDSD rat can also be utilized as a screening model for type II diabetics, its co-morbidities and obesity therapeutics.

The ZDSD rat exhibits the following phenotypic characteristics:

• Early onset of polygenic obesity in the absence of high caloric diets by two months of age
• Hyperphagia
• Spontaneous diabetes starting at about 4 months of age
• Metabolic syndrome characteristic such as
  • Hypertension
  • Insulin resistance and glucose intolerance
  • Elevated cardiovascular markers
  • Dyslipidemia
• Diabetic co-morbidities such as nephropathy and osteoporosis and wound healing
• Responds to various therapeutics

The search for new and more effective therapies for obesity, metabolic syndrome and related type II diabetes, cardiovascular diseases and end stage renal complications is currently hindered by the lack of good translational rodent models. In 2007 the FDA Guidance for Industry on Developing Products for Weight Management published “…Ideally, a therapeutic product intended to treat metabolic syndrome should normalize or improve all components of the syndrome, independent of weight loss… and ultimately be shown to prevent the development of type II diabetes and reduce cardiovascular morbidity and mortality.”

In October 2010, officials at the Centers for Disease Control and Prevention (CDC) issued a press release estimating that by the year 2050, 1 in 3 to 1 in 5 US adults could have diabetes if current trends continue. About 1 in 10 now have diabetes, and 90 to 95 percent of all diagnosed cases are type II diabetes. An estimated 57 million had pre-diabetes in 2007. These estimates indicate that, the numbers of people with diabetes will more than double by the year 2050. An estimated 285 million people worldwide had diabetes in 2010. The International Diabetes Federation expects the number to grow to 438 million by 2030. The annual direct and indirect medical care and treatment-costs for Americans with diabetes was estimated at $174 billion by the ADA in 2007.

The NIDDK Strategic Plan for the next 10 years states that “Animal model research has contributed substantially to the understanding of diabetes and obesity, but these models exhibit substantial differences when compared to these diseases in humans. New small and large animal models, as well as in silico models, are needed that better represent the pathology and treatment of human diabetes and obesity.”

CEO Pesek stated, “We believe that with the expected increase in the occurrence of obesity, metabolic syndrome and related complications, the ZDSD rat with its ‘human like’ phenotype will be the rodent of choice for the discovery and development of new therapeutics to combat these devastating and expensive diseases. Why use many models when one has it all!” Unlike most of the standard rat models in use today, the ZDSD rat does not have mutations in leptin or its receptor.

Features identified in this model make it much more applicable to studying the basic mechanisms behind obesity, metabolic syndrome and diabetes, and in identifying treatments for these conditions. Data presented on the company’s web site www.preclinomics.com also demonstrate that it is responsive to diet variation and a broad spectrum of metabolism related therapeutics.

The ZDSD rat development was partly funded by phase I and II NIH grants under the direction of Dr. Richard G. Peterson, Ph.D.. Credited with developing the male and female Zucker Diabetic (ZDF) and ZSF1 rat models, Dr. Peterson has published extensively on the ZDF rat and aspects of its disease expression.

PreClinOmics, Inc, Indianapolis, IN is an established preclinical contract research company primarily focused in supporting drug discovery and development research in the therapeutic areas of metabolic syndrome, its related complications and polycystic kidney disease. Incorporated in 2001, the Company is AAALAC accredited and has extensive technical and analytical capabilities to support PK/PD, screening and efficacy studies and related analysis.

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For more information, please contact Richard G. Peterson, PhD, EVP of Research and Development at PreClinOmics, Inc. (317) 872-6001 or rpeterson@preclinomics.com.

Examples from full study data and presentation:

These examples are also available as a PDF download:  ZDSD Overview PDF (376K)

Biochim Biophys Acta. 2011 Jan 19. [Epub ahead of print]
Ward HH, Romero E, Welford A, Pickett G, Bacallao R, Gattone VH 2nd, Ness SA, Wandinger-Ness A, Roitbak T.

Department of Pathology, University of New Mexico Health Sciences Center, Albuquerque, NM 87131, USA; Department of Medicine and Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.

Approximately 60,000 patients in the United States are waiting for a kidney transplant due to genetic, immunologic and environmentally caused kidney failure. Adult human renal stem cells could offer opportunities for autologous transplant and repair of damaged organs. Current data suggest that there are multiple progenitor types in the kidney with distinct localizations. In the present study, we characterize cells derived from human kidney papilla and show their capacity for tubulogenesis. In situ, nestin(+) and CD133/1(+) cells were found extensively intercalated between tubular epithelia in the loops of Henle of renal papilla, but not of the cortex. Populations of primary cells from the renal cortex and renal papilla were isolated by enzymatic digestion from human kidneys unsuited for transplant and immuno-enriched for CD133/1(+) cells. Isolated CD133/1(+) papillary cells were positive for nestin, as well as several human embryonic stem cell markers (SSEA4, Nanog, SOX2, and OCT4/POU5F1) and could be triggered to adopt tubular epithelial and neuronal-like phenotypes. Isolated papillary cells exhibited morphologic plasticity upon modulation of culture conditions and inhibition of asymmetric cell division. Labeled papillary cells readily associated with cortical tubular epithelia in co-culture and 3-dimensional collagen gel cultures. Heterologous organ culture demonstrated that CD133/1(+) progenitors from the papilla and cortex became integrated into developing kidney tubules. Tubular epithelia did not participate in tubulogenesis. Human renal papilla harbor cells with the hallmarks of adult kidney stem/progenitor cells that can be amplified and phenotypically modulated in culture while retaining the capacity to form new kidney tubules. This article is part of a Special Issue entitled: Polycystic Kidney Disease.

PMID: 21255643

Metabolic Syndrome is defined using a cluster of laboratory and clinical markers that identify increased risk for cardiovascular disease and type II diabetes.  As much as 25% of the adult American population can be classified with this Syndrome depending on the definition of Metabolic Syndrome used.  A number of therapies exist that treat one or more of the components of the syndrome.  Therapeutic products intended for the treatment of Metabolic Syndrome should ideally normalize or improve all of the components of the syndrome and ultimately prevent the development of type II diabetes and reduce cardiovascular risk.

Key to the development of therapies targeting Metabolic Syndrome is an animal model that spontaneously develops the complications associated with the syndrome.  The ZDSD rat currently available for sale from PreClinOmics is such a model.  Current data demonstrates that the ZDSD spontaneously develops obesity, insulin resistance, hyperglycemia, and elevated lipids.  These factors ultimately lead to the development of Type II diabetes in the model as well.  Dietary manipulation can synchronize the expression of these complications.  Studies are ongoing to characterize the cardiovascular risk factors.

Interested researchers are encouraged to contact us to inquire about receiving small cohorts of animals for feasibility studies.  These animals are provided in exchange for payment of shipping charges and control data that may be used to further understand the value of the model.

In brief, male ZDSD rats, maintained on LabDiet 5008, will spontaneously exhibit the following (click to enlarge graphs):

Obesity:

Hyperglycemia:

Insulin Resistance:

Hypertriglyceridemia:

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Similarly, the MSD insulin assay has a broad detection range, needs a sample volume of only 10-ul for a single analysis and has a high assay reproducibility (low CV) for duplicated analyses.    

If you have any Assay needs,  please contact us for analyzing metabolic, inflammatory and many other biomarkers from rodent, canine, swine and human samples by MSD, Luminex, Micro-plate (ELISA and Enzymatic), and clinical analyzer.