apocell Home Contact Us


Pre-Clinical Studies

Client: Confidential
Purpose: Assessment of Clinical Effects of Combination Therapies
Endpoints: CTC enumeration, protein expression in CTCs
Trial Sites: 1
Expected Patient Enrollment: 30
Technology: ApoStream®

Client: Confidential
Purpose: Development of Repeatable Biomarker Assay to Monitor DNA-Damage Repair Mechanisms
Endpoints: protein expression in cellular subtypes
Trial Sites: 2
Expected Patient Enrollment: n/a – assay developed in cell lines and normal donor blood

Client: Confidential
Purpose: Comparison of Biomarker Expression Levels in CTCs and Tumor Biopsies
Endpoints: CTC enumeration; protein expression levels in CTCs & tissue; FISH in CTCs & tissue
Trial Sites: 1
Expected Patient Enrollment: 20

Client: Confidential
Purpose: Optimization and Analysis of CTC Isolation Technologies
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 2
Expected Patient Enrollment: 5
Technology: ApoStream®


Phase I Trials

Client: Pfizer Oncology
Purpose: Development of a Real-Time IHC Assay for Use for Patient Stratification for Enrollment in Clinical Trials
Biomarkers: P-cadherin
Trial Sites: 3
Expected Patient Enrollment: 95
Results: EORTC-NCI-AACR 2009 meeting – Abstract C16 Davis, DW et. Al., “Prospective Real-time Analysis of P-cadherin Expression to Select Patients into a Phase I Oncology Trial”

Client: Cylene Pharmaceuticals
Purpose: Pharmacodynamic Assessment of Antitumor Activity of a CK2α-Inhibitor
Biomarkers: p21/phospho-p21, AKT/pAKT(S473, S129) in PBMCs; IL-6, IL-8 in plasma; p21/phospho-p21, AKT/pAKT(S473, S129), CK2α in CTCs
Trial Sites: 3
Expected Patient Enrollment: 50
Results: ASCO 2011 meeting – Abstract 3087Marschke, R.F. et. al., “Findings from the phase I clinical trials of CX-4945, an orally available inhibitor of CK2.”

Client: Eisai Medical Research
Purpose: Utilization of Biomarker Expression Levels for Patient Stratification Strategies for Clinical Trials
Biomarkers: Rb/pRb, ERK/pERK, pS6, AKT/pAKT, TUNEL, BRAF in CTCs
Trial Sites: 23
Expected Patient Enrollment: 40
Results: ESMO 2010 Meeting – Abstract #1335PEisen, A et. Al., “CTC Biomarker Assessment To Aid Dosing Selection of E6201, A Potent MEK1 Inhibitor, For Treatment Of BRAF-Mutated Melanoma.”

Client: Confidential
Purpose: Pharmacodynamic and Correlative Studies of Biomarker Expression Levels of Prostate Cancer Patients Treated With a Novel Antisense Drug
Endpoints: CTC count; protein expression in CTCs
Trial Sites: 16
Expected Patient Enrollment: 112
Technology: ApoStream®

Client: Confidential
Purpose: Pharmacodynamic and Correlative Studies of Biomarker Expression Levels of NSCLC Patients Treated With a Novel Antisense Drug
Endpoints: CTC count; protein expression in CTCs
Trial Sites: 20
Expected Patient Enrollment: 112
Technology: ApoStream®

Client: Confidential
Purpose: Optimization of CTC Isolation Techniques; Pharmacodynamic Analysis of Biomarkers for Correlative Studies
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 1
Expected Patient Enrollment: 10
Technology: ApoStream®

Client: Confidential
Purpose: Comparison of Genetic Markers in CTCs and Archival Tissues in Castration-Resistant Prostate Cancer Patients
Endpoints: CTC enumeration; FISH in CTCs & tissue
Trial Sites: 9
Expected Patient Enrollment: 22

Client: Confidential
Purpose: Enumeration of CTCs and Biomarker Analysis in a Phase I Study
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 4
Expected Patient Enrollment: 30

Client: Confidential
Purpose: Analysis of CTC Counts and Biomarker Expression Levels in Castration-Resistant Prostate Cancer Patients
Endpoints: CTC enumeration; protein expression in CTCs; FISH in CTCs
Trial Sites: 4
Expected Patient Enrollment: 191

Client: Confidential
Purpose: Assay Development for Detection of Activated Basophils
Endpoints: Activated basophil enumeration
Trial Sites: 2
Expected Patient Enrollment: 15


Phase II Trials

Client: Confidential
Purpose: Pharmacodynamic Assessment and Correlative Study to Determine Efficacy of Renal Cell Carcinoma Treatment
Endpoints: protein expression levels in CECs and CEPs
Trial Sites: 42
Expected Patient Enrollment: 75

Client: Confidential
Purpose: Pharmacodynamic Analysis in CTCs of a CHK2 Inhibitor
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 1
Expected Patient Enrollment: 55

Client: Confidential
Purpose: Pharmacodynamic Analysis of CTCs and Biomarkers in a Drug Comparison Study
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 18
Expected Patient Enrollment: 370

Client: Confidential
Purpose: Associative Biomarker Studies in Tissue
Endpoints: Protein expression in tissues
Trial Sites: tbd
Expected Patient Enrollment: 35

Client: Confidential
Purpose: Biomarker Analysis for Use in Patient Stratification Strategies for Clinical Trials
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 78
Expected Patient Enrollment: 120
Technology: ApoStream®


Phase III Trials

Client: Confidential
Purpose: Pharmacodynamic and Biomarker Analyses of DNA Damage Markers in Patients Treated with a Next Generation Topoisomerase I Inhibitor
Endpoints: CTC enumeration; protein expression in CTCs
Trial Sites: 11
Expected Patient Enrollment: 840
Technology: ApoStream®