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MMC in

Phase 2

Bladder Cancer | Small molecule | Oncology |UroGen Pharma Ltd.|Last Updated: Jun 16, 2017

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02307487Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC PatientsPHASE2 COMPLETED 14 — — Dec 1, 2014Jun 1, 2017Jun 16, 20172 Israel
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Study Endpoints
Primary Endpoints
Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Vital signs findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Clinical evaluation findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Lab results considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Secondary Endpoints
Rates of all adverse events or clinically relevant physical examination
15 months
Vital signs and laboratory findings
15 months
MMC maximum plasma concentration and concentration time curve during 6 hr post instillation
15 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A2EXPERIMENTAL120 mg MMC in 90ml gel
Cohort B2EXPERIMENTAL140 mg MMC in 90ml gel
Cohort C2EXPERIMENTAL160 mg MMC in 90ml gel
Cohort AEXPERIMENTAL120 mg MMC in 60ml gel
Cohort BEXPERIMENTAL140 mg MMC in 60ml gel
Cohort CEXPERIMENTAL160 mg MMC in 60ml gel
Interventions
NameTypeDescription
120 mg MMC in 90ml gelDRUG120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
140 mg MMC in 90ml gelDRUG140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
160 mg MMC in 90ml gelDRUG160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
120 mg MMC in 60ml gelDRUG120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
140 mg MMC in 60ml gelDRUG140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
160 mg MMC in 60ml gelDRUG160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patient is 18 years of age or older. * Patient has signed Informed Consent Form and is willing and able to abide by the protocol. * Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC. * No active urinary tract infection as confirmed by urine culture. * If the pati...

Countries:Israel
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Competitive Landscape -Bladder Cancer 147 trials
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