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CG53135-05, velafermin

Phase 2

Stomatitis | Small molecule | Other |Celldex Therapeutics, Inc.|Last Updated: Mar 15, 2016

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00104065Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow TransplantPHASE2 COMPLETED -Jan 1, 2005Dec 1, 2005Mar 15, 20169 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
CG53135-05, velaferminDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female patients ages \> 18 yrs * Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose me...

Countries:United States
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