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Lymfactin® gene therapy with vascularized lymph node transfer reduces compression-free swelling and enhances quality of life in breast cancer-related lymphedema: Final Phase I trial results. (PubMed, J Plast Reconstr Aesthet Surg)
This prospective multicenter study demonstrated that Lymfactin® with VLNT is safe and well tolerated. Although volume reduction was most evident in the first year, half of the patients reduced or discontinued compression use, and quality of life improved over long-term follow up.
Clinical • P1 data • Journal • HEOR
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VEGFC (Vascular Endothelial Growth Factor C)
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Lymfactin (adAptVEGF-C adenoviral vector)
5ms
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE) (clinicaltrials.gov)
P2, N=39, Completed, Herantis Pharma Plc. | Active, not recruiting --> Completed
Trial completion
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Lymfactin (adAptVEGF-C adenoviral vector)
over1year
Phase II study shows potential benefit of adenoviral vascular endothelial growth factor C (VEGF-C) and lymph node transfer in lymphedema. (PubMed, Plast Reconstr Surg)
This study was one of the few studies to objectively show a positive effect of VLNT in a prospective clinical multicenter setting. It was also the first-ever randomized prospective clinical study showing a quantitatively positive effect of a medical therapy on the edema of lymphedema although failing to show differences between groups in primary outcome measures.
Clinical • P2 data • Journal
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VEGFC (Vascular Endothelial Growth Factor C)
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Lymfactin (adAptVEGF-C adenoviral vector)
3years
Phase 1 Lymfactin® Study: 24-month Efficacy and Safety Results of Combined Adenoviral VEGF-C and Lymph Node Transfer Treatment for Upper Extremity Lymphedema. (PubMed, J Plast Reconstr Aesthet Surg)
During 24 months' of follow-up, the results indicate that Lymfactin® is well tolerated. The most promising findings were a 46% reduction in excess arm volume and a nonsignificant volume increase after garment removal at 12 months, suggesting that there is potential for the reduction of lymphedema.
P1 data • Clinical Trial,Phase I • Journal
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VEGFC (Vascular Endothelial Growth Factor C)
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Lymfactin (adAptVEGF-C adenoviral vector)
6years
Lymfactin, an investigational adenoviral gene therapy expressing VEGF-C, is currently studied in a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study in patients suffering from breast cancer associated secondary lymphedema (BCAL) (SABCS 2019)
Due to the nature of the study, there are no set formal statistical hypotheses for the efficacy endpoints, but suitable inferential statistics can be used when feasible.Present accrual and target accrual: A total of 40 patients are planned to be included in the clinical study. By the end of June 2019, 15 patients have been enrolled.Contact: Outi Lahdenperä, MDCMOHerantis Pharma PlcE-mail: outi.lahdenpera@herantis.com Tel: +358 40 511 3194
Clinical • P2 data
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VEGFA (Vascular endothelial growth factor A)
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Lymfactin (adAptVEGF-C adenoviral vector)