Recent Updates
Recently added Catalysts

Ad.hIFN-β

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

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.
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Ad.hIFN-β (BG00001, IDEC-201)DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

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 is administered to patients with colorectal carcinoma that has spread to the liver. The drug is currently in Phase 1 clinical development and is not approved by regulatory authorities.

What does Ad.hIFN-β target?

Ad.hIFN-β is designed to deliver the gene for interferon-beta, a cytokine with antiviral, antiproliferative, and immunomodulatory activities. By expressing interferon-beta locally in the tumor, the therapy aims to inhibit tumor growth and stimulate an immune response against cancer cells. The specific molecular target is not disclosed in the available information.

Who makes Ad.hIFN-β?

Ad.hIFN-β 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 gene therapy for 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 drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Ad.hIFN-β in?

Ad.hIFN-β has been studied in one completed Phase 1 clinical trial, registered as NCT00107861. This trial, titled 'Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases,' enrolled 44 participants in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is Ad.hIFN-β the same as interferon-beta?

Ad.hIFN-β is not the same as interferon-beta itself. It is a gene therapy vector that delivers the gene for human interferon-beta into cells. The drug is designed to produce interferon-beta locally within the tumor, potentially offering a targeted approach compared to systemic interferon-beta administration.