Evaluating a new treatment for microcystic lymphatic malformations
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
This study is testing a new gel called PTX-022 to see if it can safely help people with microcystic lymphatic malformations, a rare condition that affects the lymphatic system, and it's looking for participants to see how well it works and if there are any side effects.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Palvella Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Wayne, United States) |
| Project ID | NIH-11104574 on NIH RePORTER |
What this research studies
This research investigates the safety and effectiveness of a topical gel called PTX-022 for treating microcystic lymphatic malformations, a rare and chronic condition affecting the lymphatic system. Patients will be enrolled in a multicenter, phase 3 trial where they will receive the treatment and be monitored for improvements in their symptoms and overall health. The study aims to provide the first FDA-approved therapy for this debilitating condition, which currently has no approved treatments. Participants will be closely observed to assess any side effects and the gel's impact on their condition.
Who could benefit from this research
Good fit: Ideal candidates for this research are individuals diagnosed with microcystic lymphatic malformations, particularly those experiencing significant symptoms.
Not a fit: Patients without a diagnosis of microcystic lymphatic malformations or those with other lymphatic disorders may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to the first effective treatment for patients suffering from microcystic lymphatic malformations.
How similar studies have performed: Preliminary studies have shown some benefit of oral sirolimus in treating microcystic lymphatic malformations, indicating potential for success with this topical formulation.
Where this research is happening
Wayne, United States
- Palvella Therapeutics, INC. — Wayne, United States (Active)
Researchers
- Principal investigator: Martini, Jeff — Palvella Therapeutics, INC.
- Study coordinator: Martini, Jeff
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.