Approval Probability
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Adjusted LOA
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NX-1207 · 6 trials · 7 indications
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.
| Arm | Type | Description |
|---|---|---|
| Open Label Injection of NX-1207 | EXPERIMENTAL | Intraprostatic injection of 2.5 mg NX-1207 |
| NX-1207 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Active Surveillance | NO_INTERVENTION | Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer. |
| NX-1207 2.5 mg | EXPERIMENTAL | - |
| NX-1207 15 mg | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | Single therapeutic dose of 2.5 mg NX-1207 |
| 2 | EXPERIMENTAL | Single low dose of 0.125 mg NX-1207 for dose-response evaluation |
| 3 | ACTIVE_COMPARATOR | 5.0 mg finasteride q.d. |
| Name | Type | Description |
|---|---|---|
| NX-1207 | DRUG | 2.5 mg NX-1207 in 10 mL saline vehicle |
| Placebo | DRUG | Single intraprostatic injection of placebo |
| NX-1207 2.5 mg | DRUG | A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance. |
| NX-1207 15 mg | DRUG | A single intraprostatic injection of NX-1207 15 mg followed by active surveillance. |
| 2.5 mg NX-1207 | DRUG | Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207 |
| 0.125 mg NX-1207 | DRUG | Low dose; single intraprostatic injection of 0.125 mg NX-1207 |
| finasteride | DRUG | Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days) |
Inclusion Criteria: * Be male aged 45 or older. * Sign an informed consent form. * Be in good health. * Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit. ...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Medicus Pharma Ltd | MDCX | 1 | PHASE2 | Teverelix DP |