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Interferon-alpha

Phase 2

Papillomatosis | Small molecule | Infectious Disease |Ainos, Inc.|Last Updated: Sep 16, 2011

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00454181Treatment of Oral Warts in HIV+ PatientsPHASE2 COMPLETED 59Feb 1, 2007Oct 1, 2009Sep 16, 201112 United States
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Study Endpoints
Primary Endpoints
Change in Total Oral Mucosal Area Covered by Warts.
24 weeks, from baseline to the end of treatment

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

Secondary Endpoints
Total Surface Area of the Lips Covered by Warts
24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Changes in Warts
24 weeks, from baseline to the end of treatment
Subject Questionnaire Regarding Global Oral Changes
24 weeks, from baseline to end of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IFN lozengesEXPERIMENTAL500 IU Interferon-alpha lozenges for oral dissolution
placebo lozengesPLACEBO_COMPARATOR200 mg lozenges containing anhydrous crystalline maltose
Interventions
NameTypeDescription
Interferon-alphaDRUG500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks
placeboOTHER200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Must have tested positive for HIV. * Must have two or more warts inside the mouth. * Must be receiving a standard course of anti-retroviral therapy (HAART). Exclusion Criteria: * Must not be receiving oral or injected steroids. * Must not be taking other drugs for treatment ...

Countries:United States
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