Recent Updates
Recently added Catalysts

BAY86-9596

Phase 1

Diagnostic Imaging | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jan 21, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01297088PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.PHASE1 COMPLETED 24 — — May 1, 2011Dec 1, 2011Jan 21, 20132 Singapore
NCT01089998PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With InflammationsPHASE1 COMPLETED 35 — — May 1, 2010Sep 1, 2011Jan 21, 20132 Netherlands, Switzerland
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
BAY86-9596 lesion detection rate (overall number of lesions identified).
up to 2 hours
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
up to 2 hours
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
up to 2 hours
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
up to 2 hours
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
up to 2 hours
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Day of study drug administration
Secondary Endpoints
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology
At least 2 times within 8 days after treatment
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -
Interventions
NameTypeDescription
BAY86-9596DRUGOne single dose administration of a diagnostic agent
Fludeoxyglucose (18F)-IBADRUGSubgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Cancer Patients * Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computer tomography(CT) performed 14 days prior to treatment with BAY86-9596 for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass wit...

Countries:SingaporeNetherlandsSwitzerland
Unlock Eligibility Criteria
Competitive Landscape -Diagnostic and Imaging 9 trials
CompanyTickerTrialsLead PhaseDrugs
Hologic, Inc.HOLX1NAUndisclosed
Intelligent Bio Solutions Inc.INBS1 — Undisclosed
HeartFlow, Inc.HTFL1NARosuvastatin
GE Healthcare Technologies Inc.GEHC2NAUndisclosed
Unity Health TorontoUBX1 — Undisclosed
Unlock Competitive Intelligence