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Also known as SCH 721015, Ad.hIFN-beta
Adenoviral-mediated Interferon-beta · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Dose level 4 | EXPERIMENTAL | - |
| Dose level 5 | EXPERIMENTAL | - |
| Dose Level 1 | EXPERIMENTAL | on Days 1 and 15 |
| Dose Level 2 | EXPERIMENTAL | On Days 1 and 15 |
| Dose Level 3 | EXPERIMENTAL | On Days 1 and 15 |
| Name | Type | Description |
|---|---|---|
| Adenoviral-mediated Interferon-beta | BIOLOGICAL | BG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8 |
| SCH 721015 | BIOLOGICAL | Comparison of different doses and frequency of investigational agent |
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...
Adenoviral-mediated interferon-beta is an investigational gene therapy being studied for pleural mesothelioma and metastatic pleural effusions, cancers affecting the lining of the lungs. It delivers the interferon-beta gene directly into the pleural cavity. Biogen Inc. developed it, and the only recorded trial enrolled 17 participants with these pleural malignancies.
Adenoviral-mediated interferon-beta was developed by Biogen Inc., which trades on Nasdaq under the ticker BIIB. The company sponsored the Phase 1 gene therapy study in pleural malignancies. No later-stage program for this asset has been recorded, and the trial is listed as completed.
Adenoviral-mediated interferon-beta is in Phase 1 development. It has not been approved by the FDA and remains an investigational gene therapy. Its single recorded study, NCT00299962, titled Gene Therapy for Pleural Malignancies, is completed and enrolled 17 participants. No Phase 2 or later trial for this asset has been recorded.
Adenoviral-mediated interferon-beta was evaluated in one clinical trial, NCT00299962, titled Gene Therapy for Pleural Malignancies. The Phase 1 study enrolled 17 participants with pleural mesothelioma or metastatic pleural effusions, accepted adults 18 years and older of any sex, and was conducted in the United States. It is now completed.
The Phase 1 trial NCT00299962 was a controlled study that enrolled 17 participants. It was not randomized and not double blinded, and participants were not selected by biomarker. The study included adults 18 years and older of any sex with pleural mesothelioma or metastatic pleural effusions, and it did not enroll healthy volunteers.