In This Article:
Presentation to highlight SELVA, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin 3.9% anhydrous gel for the treatment of microcystic lymphatic malformations
WAYNE, Pa., April 02, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced a late-breaking oral presentation at the upcoming 15th World Congress of Pediatric Dermatology, taking place April 8-11, 2025, in Buenos Aires, Argentina.
The oral presentation will highlight SELVA, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin 3.9% anhydrous gel for the treatment of microcystic lymphatic malformations. The details are as follows:
15th World Congress of Pediatric Dermatology Abstract
Title: SELVA: A Phase 3 study with a fit-for-purpose primary endpoint evaluating QTORIN™ 3.9% rapamycin anhydrous gel in the treatment of microcystic lymphatic malformations in patients 3 years of age and older
Presenter: Amy Paller, M.S., M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, and Principal Investigator of the NIH-funded Skin Biology and Diseases Resource-based Center at Northwestern University's Feinberg School of Medicine
Session: Free Communications VII: Case Series & Clinical or Epidemiological Studies
Session Date, Time & Location: Friday, April 11, 2025 between 8:30-10:00 am GMT-3 in room F
About Microcystic Lymphatic Malformations
Microcystic LMs are a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization. The natural history of microcystic LMs is persistent and progressive without spontaneous resolution, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 diagnosed patients with microcystic LMs in the United States.