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Phase IIIb Clinical Data Validate the Overall and Cardiovascular,Safety Profile of Cycloset (A Quick Release Formulation of,Bromocriptine Mesylate) in Patients with Type 2 Diabetes

day, June 23-25, in the General Poster Session: Poster # 50-LB, Effects of Timed Cycloset(TM) (A Quick Release Formulation of Bromocriptine Mesylate) Administration on Safety, Cardiovascular Event Rate, and Glycemic Control in Subjects with Type 2 Diabetes Receiving Diet, Oral Hypoglycemic, and/or Insulin Treatment Regimens. JM Gaziano, M Ezrokhi, AH Cincotta, RE Scranton.

About Cycloset(TM) (A Quick Release Formulation of Bromocriptine Mesylate)

Cycloset(TM) is an oral, quick-release formulation of bromocriptine, a centrally-acting dopamine D2 receptor agonist. When given as a single timed (morning) daily dose, Cycloset(TM) is believed to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in insulin resistant subjects. Results of published clinical studies suggest that treatment with Cycloset(TM) may improve hyperglycemia, glucose intolerance, hyperlipidemia, or aspects of insulin resistance, while maintaining body fat neutrality or inducing body fat reduction.

Cycloset(TM) is currently under investigation as a potential therapy for type 2 diabetes and has been studied in several Phase II and three Phase III studies. An NDA for the drug's use in the treatment of type 2 diabetes has received an approvable letter from the FDA detailing the remaining data required for approval, primarily a large, simple safety trial. VeroScience anticipates filing an amended Cycloset(TM) NDA (a complete response to the approvable letter) in the late third or fourth quarter of 2007.

About VeroScience, LLC

VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, RI. VeroScience has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabol
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Gentamicin Reagent Solution (10 mg/ml) liquid
LB Agar plates with 0.1mM EDTA.
Luria bertani broth: 1.0% Tryptone, 0.5% Yeast Extract, 1.0% Sodium Chloride.
2.5% Soytone, 4.8% Yeast Extract, 0.025% Magnesium Sulfate, 130mM Calcium Chloride.
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