Phase 1 LymfactinⓇ Study: Short-term Safety of Combined Adenoviral VEGF-C and Lymph Node Transfer Treatment for Upper Extremity Lymphedema

Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS
Pauliina HartialaAnne M Saarikko

Abstract

To study the safety and tolerability of LymfactinⓇ treatment combined with microvascular lymph node transfer surgery in patients with upper limb lymphedema. Upper limb lymphedema is a common clinical challenge after breast cancer surgery and/or radiotherapy. LymfactinⓇ is an adenovirus type 5-based gene therapy involving expression of human vascular endothelial growth factor C (VEGF-C) in the damaged tissue. It aims to correct deficient lymphatic flow by promoting the growth and repair of lymphatic vessels. In Phase I, LymfactinⓇ was combined with microvascular lymph node transfer surgery to study the safety and tolerability of LymfactinⓇ and the biodistribution of the viral vector in patients with upper limb lymphedema. Fifteen patients with breast cancer-associated secondary lymphedema of the upper arm were recruited between December 2016 and February 2018. Three patients received a lower dose (1 × 1010) and 12 a higher dose (1 × 1011) of viral particles, respectively. No dose-limiting toxicities were observed, and the study was completed with the pre-determined maximum dose. Commonly reported adverse events during the 12-month follow-up were common cold, fever, gastroenteritis, pain in the operation area, headache, muscle ac...Continue Reading

Citations

Jan 28, 2021·Annual Review of Medicine·Wenjing XuKathleen M Caron
Apr 4, 2021·Biology·Bianca BrixNandu Goswami
May 1, 2021·Biology·Sebastian Lucio FilelfiNandu Goswami
Jun 11, 2021·Circulation Research·Stanley G Rockson
Aug 2, 2021·Trends in Molecular Medicine·Simon StrittTaija Mäkinen
Sep 16, 2021·Advances in Wound Care·Cynthia SungAlex K Wong

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