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Cell death related markers
Phospho-Protein markers
Pathway-resistance markers
Angiogenesis markers

Cell death related markers :

  1. Ideal for novel drug candidates with mechanism of action to kill tumor cells directly or indirectly by interfering DNA-repair process
  2. Signals of cell death detected on or within CTCs could provide proof of concept of novel therapeutics in patients in Phase I or Phase II clinical studies
  3. Potential uses in clinic: proof-of-concept, dosing selection
  4. Potential markers could be examined in CTCs:
  • Apoptosis:  Caspases 2, 3, 7, 8 and 9, neo-epitopoe of CK18 (M30), annexin –V, Tunel
  • DNA-repair:  p53, phosphorylated p-53, p21, pRb, 
  • Nuclear DNA damage marker:  γ-H2AX

Phospho-Protein markers :

  1. Ideal for novel drug candidates with mechanism of action in blocking growth factor/receptor interaction or directly blockade of downstream signaling events
  2. Modulation of intracellular phosphor-protein expression in CTCs or CECs isolated from treated patients could signal drug activity in Phase I or Phase II studies
  3. Potential uses in clinic: proof-of-concept study, dosing selection study, markers to assist patient stratification strategies in advance clinical study
  4. Potential markers can be examined in CTCs and in CECs including, but not limited to:
  • pERK/ERK,
  • pAKT/AKT,
  • pFGFR1/FGFR1,
  • cMET,
  • pVEGFR/VEGFR ,
  • TIE2

Functional Biomarkers

Pathway-resistance markers:

  1. Ideal for novel drug candidates that target a specific pathway-resistance patient population
  2. Potential uses in clinic: patient selection/stratification
  3. Potential markers can be examined in CTCs:
  • BRAF mutation
  • EGFR mutation and amplification
  • KRAS mutation
  • PI3KCA mutation
  • PTEN loss
  • TMPRESS-ERG fusion

Angiogenesis markers:

  1. Ideal for novel drug candidates with mechanism of action to interfere/block angiogensis
  2. Potential uses in clinic: proof-of-concept study, dosing selection study
  3. Potential markers can be examined:
  • CEC/CEP count
  • pVEGFR/VEGFR