Ralf Gutzmer
Germany
Research Article
Aviscumine (ME-503)-Skin Reaction as significant Factor for its Efficacy Expanded Evaluation of the Results from the Phase II Trial NCT00658437 in Patients with Unresectable stage IV Metastatic Melanoma
Author(s): Uwe Trefzer, Ralf Gutzmer, Tabea Wilhelm, Florian Schenck, Katharina C. Kähler, Volkmar Jacobi, Klaus Witthohn, Hans Lentzen and Peter MohrUwe Trefzer, Ralf Gutzmer, Tabea Wilhelm, Florian Schenck, Katharina C. Kähler, Volkmar Jacobi, Klaus Witthohn, Hans Lentzen and Peter Mohr
Aviscumine (ME-503), a recombinant lectin, enhances inflammatory cytokine (esp. IL-1β) release, activation of Langerhans cells, and T-cell responses. An extended evaluation of phase II data of the patient cohorts with/without skin reactions within the first treatment cycle after SC injection regarding the efficacy of aviscumine are presented. 31 patients (ITT total population) (ECOG: 0 or 1) with progressive stage IV malignant melanoma after failure of standard therapy were enrolled onto a single-arm, multi-centre, open-label, phase II trial (NCT00658437). Patients received 350 ng aviscumine twice weekly by SC injection until progression. Tumor response was assessed every eight weeks, survival of patients was followed up to one year after the end of therapy. 21 patients with skin reactions vs. 9 patients without skin reactions as adverse events were assessed for efficacy.. View More»
