Recent Updates
Recently added Catalysts

Adenoviral-mediated Interferon-beta

Phase 1

Pleural Mesothelioma | Monoclonal antibody | Oncology |Biogen Inc.|Last Updated: Mar 18, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

Adenoviral-mediated Interferon-beta · 1 trial · 2 indications

Phase 1 1
NCT00299962Gene Therapy for Pleural MalignanciesPleural Mesothelioma
COMPLETED17 Analytics
PHASE1COMPLETED
Gene Therapy for Pleural Malignancies
Pleural MesotheliomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Through Day 85

Secondary Endpoints

To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
Through Day 85
and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
15 years or until subject dies, whichever comes first
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 4EXPERIMENTAL -
Dose level 5EXPERIMENTAL -
Dose Level 1EXPERIMENTALon Days 1 and 15
Dose Level 2EXPERIMENTALOn Days 1 and 15
Dose Level 3EXPERIMENTALOn Days 1 and 15

Interventions

NameTypeDescription
Adenoviral-mediated Interferon-betaBIOLOGICALBG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015BIOLOGICALComparison of different doses and frequency of investigational agent
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma * must have evaluable disease * must have ECOG performance status of 2 * must have pleural space involved with tumor accessible...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Adenoviral-mediated Interferon-beta

What is Adenoviral-mediated Interferon-beta used for?

Adenoviral-mediated Interferon-beta is an investigational gene therapy being studied for the treatment of pleural mesothelioma and metastatic pleural effusions. It is administered via gene therapy to deliver interferon-beta to the affected area. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Adenoviral-mediated Interferon-beta?

Adenoviral-mediated Interferon-beta is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational therapy for pleural mesothelioma and metastatic pleural effusions.

What phase is Adenoviral-mediated Interferon-beta in?

Adenoviral-mediated Interferon-beta is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Adenoviral-mediated Interferon-beta in?

Adenoviral-mediated Interferon-beta has one completed clinical trial registered under NCT00299962, titled 'Gene Therapy for Pleural Malignancies.' This Phase 1 study enrolled 17 participants in the United States with pleural mesothelioma or metastatic pleural effusions. The trial was controlled but not randomized or double-blinded.

How does Adenoviral-mediated Interferon-beta work?

Adenoviral-mediated Interferon-beta works by using an adenoviral vector to deliver the gene for interferon-beta directly into the pleural space. This approach aims to produce interferon-beta locally, which may help treat pleural malignancies. The drug is designed to target cancer cells in the pleural cavity.