PreClinOmics™ (PCO), a Contract Research and Service Company, is dedicated to providing high quality in vivo, preclinical, laboratory services for the Pharmaceutical and Biotech industry. PCO currently specializes in complex disease disorders such as diabetes, hypertension, heart and renal failure and obesity as either a primary study or validation source for compounds used in the treatment of these disorders. We are currently expanding our capabilities to include experimental protocols geared to the study of solid tumor cancers.
PCO was formed in July 2001 by the same management team and advisors that established Genetic Models Inc, in 1991. Genetic Models (Gmi) brought to the scientific research community such animal models as the ZDF, SHHF, and ZSF1. These models have proven themselves to be excellent research subjects for the study of the etiology of diabetes, hypertension, heart failure, hyperlipidemia and kidney failure, and for the demonstration of efficacy and mechanism of compounds in these disorders.
PCO recently expanded its staff of highly skilled technicians, and in concert with project consultants, aims to fulfill its mission to provide services with a "zero defect" standard of excellence in a highly responsive time-frame. Being a relatively small company, project costs remain competitive. Studies can be conducted according to Good Laboratory Practice (GLP) standards as though PCO's facilities are an extension of the sponsor's lab. The company is actively pursuing AAALAC and GLP accreditation.
PCO routinely conducts in vivo studies in rodents for:
Acute and chronic efficacy monitoring parameters significant to the control of diabetes, obesity, hypertension and cardiovascular diseases.
Drug Delivery (diet, i.p., p.o., s.c.. cannulated and tail vein i.v.)
Drug Formulation
PK
Tolerability
PreClinOmics™ (PCO) is a Contract Research and Service Company dedicated to providing high quality in vivo, preclinical, laboratory services for the Pharmaceutical and Biotech industry, as either a primary or a study validation source. PCO currently specializes in metabolic disease disorders including diabetes, hypertension, hyperlipidemia, heart failure, obesity and renal failure.
Services
In Vivo Services:
Acute and Chronic Dosing Studies in rodent models
Limited Early Safety Studies
Drug Formulation (limited)
PK - dosing and specimen collection - analysis can be sub-contracted out or the samples returned to the Sponsor
PD - dosing and tissue collection/preservation
Large animal study coordination - domestic and international
Consulting
Study Design
In Vivo Study Support:
AALAS certified technicians
Consulting
Experience in multiple dosing procedures
20,000 sq. ft. of animal rooms and support areas
In-house analytical laboratory
Surgical suite
Telemetry
In Vitro Services:
Stable Cell Line Generation
Sample Analysis
Clinical Chemistry
ELISA
Luminex
Hematology
Preclinical and Clinical Anti-obesity and Anti-diabetes Targets
Anti-obesity
Obesity has become a global epidemic. 1.1 billion people worldwide are estimated to be over their ideal weight, i.e., with a body mass index (BMI) above 24.9 kg m-2 (Melnikova, I, Wages, D Nature Reviews Drug Discovery 5:369-370, 200). In the United States, 127 million people or 65% of adults, and an increasing number of children and adolescents are considered overweight (BMI >24.9 kg m-2) or obese (BMI > 30 kg m-2) (Melnikova, I, Wages, D Nature Reviews Drug Discovery 5:369-370, 200). Obesity is associated with and often considered to precipitate other conditions such as type 2 diabetes, hypertension, cardiovascular disease, stroke, certain types of cancer, gout, sleep apnea, etc.
Obesity is a condition in which energy intake exceeds energy expenditure. Diet and exercise are the preferred weight controlling approaches but usually not effective for long-term efficacy due to the lack of discipline by the individual and the body's ability to adjust its energy efficiency (Leibel, RL, Rosenbaum M, Hirsch J New England J Med 332:621-8, 1995). Pharmacological intervention approaches have attempted to take advantage of both sides of the energy equation, i.e., limiting energy intake and increasing energy expenditure by regulating metabolism.
Currently, only sibutramine and orlistat have been approved for anti-obesity indication. Rimonabant could become the third anti-obesity drug with a FDA approvable letter issued in February, 2006. All of them aim at controlling energy intake. Sibutramine is a dual serotonin and norepinephrine reuptake inhibitor that suppresses appetite (Nisoli E, Carruba MO Drug Saf 26:1027-48, 2003). Orlistat is a lipase inhibitor that blocks fat absorption (Nelson RH, Miles JM Expert Opinion Pharmacotherapy 6:2483-91, 2005). Rimonabant is an appetite suppressant through its antagonism on the cannabinoid type I (CB1) receptor (Pi-Sunyer, FX et al. J Am Med Assoc 295:761-765, 2006). Although sibutramine and orlistat received limited marketing success relative to the potential anti-obesity market because of their respective side effects, these drugs do demonstrate that limiting energy intake either through appetite suppression or blocking nutrient absorption could achieve certain degree of clinical efficacy in weight control. On the other hand, no drug has been approved to date for anti-obesity by metabolic modulation and thus, the concept of using a "metabolic agent" (vs. an appetite suppressant) as an anti-obesity drug remains at the exploratory, pre-clinical stage.
Listed below are compounds that have been investigated and reported in literature as potential novel anti-obesity drugs. The compounds are classified by their anti-obesity mechanisms or by structures or known indications if their anti-obesity mechanisms are yet to be elucidated. The reduction of body weight and body fat composition has therapeutic effects on the control of type 2 diabetes. Thus, anti-obesity drugs could potentially be anti-diabetes drugs through, e.g., the indirect improvement of insulin sensitivity. Some of these compounds may also have direct therapeutic effects on both body weight and blood glucose.