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Interferon-alpha

Phase 3

Influenza A Virus Infection | Small molecule | Infectious Disease |Ainos, Inc.|Trials Updated: Aug 21, 2013

Interferon-alpha development status

Highest phase Phase 3 run by University of Ulm (NCT01060501)
Phase scored for AIMDPhase 2
Registered trials 6 across 4 sponsors since Mar 2007

Interferon-alpha target and mechanism

ModalitySmall molecule

Also known as IFN lozenge, IFN-alpha lozenge, Veldona, low dose IFN lozenge

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment383

FDA Designations

No designations recorded

Interferon-alpha clinical trials

Interferon-alpha · 4 trials · 7 indications

Phase 2 4
NCT00483184Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's DiseaseBehcet Syndrome
COMPLETED84 Analytics
NCT01146535Interferon Alpha Lozenges Plus Oseltamivir for Influenza TreatmentInfluenza A Virus Infection
COMPLETED40 Analytics
NCT00895947Interferon Alpha Lozenges in the Prevention of Winter Colds and FluUpper Respiratory Tract Infections
COMPLETED200 Analytics
NCT00454181Treatment of Oral Warts in HIV+ PatientsPapillomatosis
COMPLETED59 Analytics
PHASE2COMPLETED
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
Behcet SyndromeUnlock trial analytics
PHASE2COMPLETED
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Influenza A Virus InfectionUnlock trial analytics
PHASE2COMPLETED
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Upper Respiratory Tract InfectionsUnlock trial analytics
PHASE2COMPLETED
Treatment of Oral Warts in HIV+ Patients
PapillomatosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.
(0-12 weeks)

A patient with a 75% or greater decrease in total OU for three visits was considered a "sustained responder".

Resolution of fever and flu symptoms
Days 1-5

Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR).

Frequency of Influenza-like Illness
16 weeks

Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).

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

Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety
12 weeks
Clinical response
Day 3 and Day 6
Proportion of poor responders
Day 3 and Day 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR(placebo)0 IU IFNa
2EXPERIMENTAL(Veldona)500 IU IFNα bid
3EXPERIMENTAL(Veldona)1000 IU IFNα bid
Interferon-alphaEXPERIMENTALInterferon-alpha 150 IU lozenges bid for 5 days
maltosePLACEBO_COMPARATORmaltose 200 mg maltose lozenges bid for 5 days
placeboPLACEBO_COMPARATORplacebo lozenges
IFN lozengesEXPERIMENTAL500 IU Interferon-alpha lozenges for oral dissolution
placebo lozengesPLACEBO_COMPARATOR200 mg lozenges containing anhydrous crystalline maltose

Interventions

NameTypeDescription
Veldona,BIOLOGICALVery low dose oral natural human interferon alpha lozenges
Interferon-alphaDRUG150 IU lozenges bid for 5 days
OseltamivirDRUG75 mg capsules bid for 5 days
maltoseOTHER200 mg maltose lozenges bid for 5 days
placeboOTHERplacebo lozenges for oral dissolution taken once daily for 16 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Is a male or a non-pregnant, non-lactating female. * Has a history and clinical presentation consistent with a diagnosis of Behçet's Disease and meets International Study Group criteria (Appendix B). * Has a history of oral ulcers for at least 12 months. * Has a history of mon...

Countries:Turkey (Türkiye)TaiwanAustraliaUnited States
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Frequently asked questions about Interferon-alpha

What is Interferon-alpha used for?

Interferon-alpha is an investigational small molecule being developed by Ainos, Inc. for the treatment of Influenza A Virus Infection, Upper Respiratory Tract Infections, and Papillomatosis. It is currently in Phase 2 clinical development for these infectious disease indications.

What does Interferon-alpha target?

Interferon-alpha is a small molecule that belongs to the interferon class of drugs. It works by modulating the immune system's response to viral infections, though the specific molecular target has not been disclosed in the available clinical trial information.

Who makes Interferon-alpha?

Interferon-alpha is being developed by Ainos, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol AIMD on the NASDAQ stock exchange.

What phase is Interferon-alpha in?

Interferon-alpha is currently in Phase 2 clinical development. It has completed three Phase 2 clinical trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Interferon-alpha in?

Interferon-alpha has completed three Phase 2 clinical trials. These include NCT00454181 for oral warts in HIV+ patients, NCT00895947 for prevention of winter colds and flu, and NCT01146535 for influenza treatment in combination with oseltamivir. All trials have been completed.

Is Interferon-alpha the same as other interferon drugs?

Interferon-alpha is a specific type of interferon, a class of proteins with antiviral and immunomodulatory properties. While it shares the general mechanism of interferons, it is a distinct drug being developed by Ainos, Inc. for specific indications.