Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R-enantiomer of 1, 2-dioleoyl-3-trimethylammonium-propane chloride+ Peptides from HPV-16 E6 and E7 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Low Dose) | ACTIVE_COMPARATOR | The group will receive the lowest dose of the vaccine |
| Cohort 2 (Mid Dose) | ACTIVE_COMPARATOR | The Group will receive the middle dose of the vaccine |
| Cohort 3 (High Dose) | ACTIVE_COMPARATOR | The Group will receive the highest dose of vaccine to be tested |
| Name | Type | Description |
|---|---|---|
| R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7 | BIOLOGICAL | - |
Inclusion Criteria: 1. Written informed consent prior to initiation of any study-related procedures; 2. Nonlactating female between the ages of 21 to 65 years, inclusive; 3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contrac...
PDS0101 is being developed for high-risk HPV infection and biopsy-proven CIN1, which is low-grade cervical intraepithelial neoplasia. It is an investigational immunotherapy studied in adult women aged 21 and older. The Phase 1 study enrolled 12 participants in the United States.
PDS0101 is being developed by PDS Biotechnology Corporation, which trades under the ticker PDSB. The company sponsored the Phase 1 study of the candidate in high-risk HPV infection and biopsy-proven CIN1. No other developer is named for this asset.
PDS0101 is in Phase 1 clinical development. Its single Phase 1 trial, NCT02065973, has been completed, and no trials are currently active. The study was an open-label, escalating dose evaluation of safety, tolerability, and pharmacodynamics in high-risk HPV infection and biopsy-proven CIN1.
PDS0101 has been studied in one completed Phase 1 trial, NCT02065973, titled an open-label, Phase I, escalating dose study to evaluate the safety, tolerability, and pharmacodynamics of PDS0101. It enrolled 12 female participants aged 21 and older in the United States and was active controlled, without randomization or double blinding.