Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRGN-2012 · 1 trial · 3 indications
A complete response is defined as no requirement for surgical intervention in the 12 months after treatment
The incidence of dose limiting toxicities in Phase 1 will be reported per dose level. The dose level at which less than or equal to 1 out of 6 patients experience DLT will be identified as a RP2D.
| Arm | Type | Description |
|---|---|---|
| Phase I; Dose Level 1 | EXPERIMENTAL | A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 1 × 10\^11 |
| Phase I; Dose Level 2 | EXPERIMENTAL | A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 5 × 10\^11 |
| Phase II; Dose Level 2 | EXPERIMENTAL | A dose of 5 x 10\^11 PU was established as the RP2D, and the Phase 2 portion was implemented. The Phase 2 portion is designed as a dose expansion study, where patients were treated at the RP2D to evaluate the safety and efficacy of PRGN-2012. |
| Name | Type | Description |
|---|---|---|
| PRGN-2012 - Phase I; Dose Level 1 | DRUG | In Phase 1, dose level 1 of the clinical trial, PRGN-2012 is administered at 1 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery. |
| PRGN-2012 - Phase I; Dose Level 2 | DRUG | In Phase 1, dose level 2 of the clinical trial, PRGN-2012 is administered at 5 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery. |
| PRGN-2012 - Phase II; Dose Level 2 | DRUG | The Phase 2 portion is designed as a dose expansion study where patients are treated at the RP2D of 5 x 10\^11 PU. |
INCLUSION CRITERIA: * Age 18 years and older * Clinical diagnosis of RRP * Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified (or comparable) laboratory * Presence of laryngotracheal papillomas with or without pulmonary RRP * A history of 3 or more interv...
PRGN-2012 is an investigational therapy being developed for recurrent respiratory papillomatosis, a rare condition in which benign papillomas grow in the respiratory tract. It is being studied as an adjuvant treatment in adult patients with this disease. The therapeutic area is infectious disease, and the drug has not been approved for any use.
PRGN-2012 is being developed by Precigen, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol PGEN. Precigen is the sponsor of the clinical program evaluating the drug in recurrent respiratory papillomatosis.
PRGN-2012 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial is listed as active but not recruiting, with an estimated enrollment of 38 participants.
PRGN-2012 is being evaluated in one clinical trial, NCT04724980, titled "Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis." The trial is a Phase 1 study with an estimated enrollment of 38 adults aged 18 years and older, and it is being conducted in the United States.