Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRGN-2012- Phase I; Dose Level 1 · 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 studied for the treatment of Recurrent Respiratory Papillomatosis, a condition caused by papillomavirus infections. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in adult patients with this condition.
PRGN-2012 is being developed by Precigen, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PGEN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Recurrent Respiratory Papillomatosis.
PRGN-2012 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is active but not recruiting participants, and the drug has received several FDA designations including Breakthrough Therapy, Orphan Drug, Accelerated Approval, and Priority Review.
PRGN-2012 is being studied in a Phase 1 clinical trial with the identifier NCT04724980, titled 'Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis.' This trial is active but not recruiting, with an enrollment of 38 participants in the United States. The study is controlled but not randomized or double-blinded.
PRGN-2012 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. However, it has received FDA designations including Breakthrough Therapy, Orphan Drug, Accelerated Approval, and Priority Review, which are intended to expedite its development and review process.