Palvella to present significant Phase 3 SELVA and Phase 2 TOIVA rapamycin data on May 20
Palvella Therapeutics secured acceptance of late-breaking abstracts showcasing QTORIN™ 3.9% rapamycin gel’s statistically significant, clinically meaningful improvements in microcystic lymphatic malformations (Phase 3 SELVA) and cutaneous venous malformations (Phase 2 TOIVA). James Treat, MD, will present these data on May 20 at 4:30 p.m. ET at the ISSVA World Congress.
1. ISSVA Presentation Accepted
Palvella received acceptance of late-breaking abstracts for presentation May 20 at 4:30 p.m. ET during the ISSVA World Congress in Philadelphia. Presenter James Treat, MD, will detail the clinical results from both trials.
2. Phase 3 SELVA Study Results
The SELVA study of QTORIN™ 3.9% rapamycin gel demonstrated statistically significant, clinically meaningful reductions in lesion size and symptom severity in microcystic lymphatic malformations. These results support potential therapeutic benefit in a condition lacking FDA-approved treatments.
3. Phase 2 TOIVA Study Results
In the TOIVA study, QTORIN™ rapamycin achieved significant improvements in cutaneous venous malformation symptoms and lesion appearance compared to baseline measures. The data reinforce the gel’s potential across multiple vascular malformations.
4. Strategic Implications
These late-breaking presentations could accelerate regulatory discussions and bolster Palvella’s positioning for Breakthrough Therapy Designation. Positive reception at ISSVA may enhance investor confidence and pave the way for commercialization planning.