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Ad.hIFN-β

Phase 1

Colorectal Carcinoma | Small molecule | Oncology |Biogen Inc.|Trials Updated: Jul 14, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Ad.hIFN-β clinical trials

Ad.hIFN-β · 1 trial · 2 indications

Phase 1 1
NCT00107861Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver MetastasesColorectal Carcinoma
COMPLETED44 Analytics
PHASE1COMPLETED
Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
Colorectal CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

- Evaluate the safety of a single IV administration of Ad.hIFN-β.

Secondary Endpoints

Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Ad.hIFN-β (BG00001, IDEC-201)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma. * Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI). * Tumor progression after prior therapy for colorectal carcinoma, inc...

Countries:United States
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Frequently asked questions about Ad.hIFN-β

What is Ad.hIFN-β used for?

Ad.hIFN-β is an investigational gene therapy being studied for the treatment of refractory colorectal carcinoma with liver metastases. It was evaluated in a Phase 1 trial in patients whose colorectal cancer had spread to the liver and had not responded to prior treatment.

Who is developing Ad.hIFN-β?

Ad.hIFN-β is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. The company sponsored the Phase 1 study of the agent in refractory colorectal carcinoma with liver metastases.

What phase is Ad.hIFN-β in?

Ad.hIFN-β is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is Ad.hIFN-β in?

Ad.hIFN-β was studied in one completed Phase 1 trial, NCT00107861, titled Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases. The trial enrolled 44 patients in the United States and was an uncontrolled study without randomization or blinding.

Is Ad.hIFN-β the same as BG00001 or IDEC-201?

Yes. Ad.hIFN-β is also known as BG00001 and IDEC-201. These names refer to the same investigational agent developed by Biogen for refractory colorectal carcinoma with liver metastases.