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Obatoclax

Phase 2

Myelodysplastic Syndromes | Small molecule | Hematology |Teva Pharmaceutical Industries Limited|Last Updated: Aug 26, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00413114Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)PHASE2 COMPLETED 24Dec 1, 2006Nov 1, 2009Aug 26, 201322 United States, Canada
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Study Endpoints
Primary Endpoints
International Working Group (IWG) Response Criteria for MDS
52 weeks

Determine the response rate according to bone marrow blast count less than or equal to 10%

Secondary Endpoints
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
52 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Obatoclax MesylateEXPERIMENTALObatoclax Mesylate 30mg
Interventions
NameTypeDescription
Obatoclax mesylate (GX15-070MS)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Pathological confirmation of Myelodysplastic Syndromes (MDS) * Patients must have had no prior systemic therapy * Must have normal organ functions * Must have the ability to understand and willingness to sign a written informed consent form Exclusion Criteria: * Must not be ...

Countries:United StatesCanada
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
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