Clinical Monitoring & Screening

During drug discovery and early clinical development, it is essential to have multiple mechanism-related readouts that predict successful clinical outcomes. This segment of research at the Pharmaceutical Research Institute provides key information that will help bridge the gap between experimental and clinical results. Additionally, this segment provides surrogates that are linked to clinical outcomes.

Some activities include identifying potent integrin ligands and other biological targets for therapeutic and diagnostic applications; establishing screening strategy, endothelial cell migration, proliferation, tube information and in vitro neovascularization models; establishing the CAM assay for angiogenesis, tumor growth and metastasis; screening for anti-platelet and anti-coagulant potency; and collaborating with different groups in search of novel strategies.

Biomarkers research at PRI-Albany includes:

• Endotoxin in human. This acute model might be useful in evaluating the efficacy of anti-inflammatory agents in Phase IIA.
  
• Deep vein thrombosis and pulmonary embolism
  
• Congestive heart failure
  
• Coronary artery diseases
  
• Interventional procedures for abrupt closure and restenosis
  
• Inflammatory diseases
  
• Vascular, ocular, oncological and hematological disorders
  

Surrogate markers in clinical samples might include:

• Tissue factor (TF)
  
• C-reactive protein (CRP)
  
• Soluble P-, E- and L-selectins
  
• Von Wilebrand factor (vWF)
  
• Soluble vascular cell adhesion molecule-1 (VCAM-1)
  
• Soluble intracellular cell adhesion molecule-1 (ICAM-1)
  
• F1.2
  
• D-dimer
  
• Protein C
  
• Protein S
  
• Tumor necrosis factor-alpha (TNF-a)
  
• TNF-soluble receptors
  
• Nitric oxide
  

Therapeutic and diagnostic opportunities exist to define anti-thrombotic targets to be used in conjunction with standard anti-cancer agents, and to define novel prognostic and diagnostic markers of specific cancer pro-thrombotic markers.

Pharmaceutical Research Institute at Albany College of Pharmacy
1 Discovery Drive, Rensselaer, NY 12144 518-694-7575, fax 518-694-7567