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Alferon LDO

Phase 2

Severe Acute Respiratory Syndrome | Small molecule | Other |AIM ImmunoTech Inc.|Last Updated: Apr 17, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00215826Study of Alferon® LDO (Low Dose Oral) in Normal VolunteersPHASE2 COMPLETED 10Nov 1, 2004Apr 1, 2006Apr 17, 20131 Hong Kong
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Study Endpoints
Primary Endpoints
Gene expression analysis
Days 0, 2, 6, 11, 12, 15, 20 and 40

Increased expression of genes known to be mediators of interferon response.

Secondary Endpoints
SARS CoV Antibody
Days 0, 15, 20 and 40
SARS-CoV infection
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR650 IU
2ACTIVE_COMPARATOR1300 IU
Interventions
NameTypeDescription
Alferon LDODRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. 18-80 years of age. 2. Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2 (SARS Report under investigation), RUI-3, RUI-4) or probable SARS or confirmed SARS using the Centers for Disease Control and Prevention (CDC) S...

Countries:Hong Kong
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