Hamburg, August 19, 2014 – MELEMA Pharma GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today announced Phase II data demonstrating that its lead compound Aviscumine (ME-503), an immune potentiator, may improve survival of patients with refractory metastatic melanoma (stage IV). The data are published now in Journal for Immunotherapy of Cancer 2: 27 (2014).
The open-label Phase II multicenter trial (NCT00658437)was designed to test the influence of subcutaneous injections of Aviscumine (ME-503) on progression-free survival (PFS) and overall survival (OS) of patients with unresectable metastatic melanoma (stage IV) after antineoplastic treatment failure. The trial included 31 eligible patients and was conducted at four German sites.
The progression-free survival rate after 3 months was 32.3%, while the 1-year-survival rate was 45.0% and median overall survival time (mOS) 11 months in the full analysis set/intention to treat population (FAS/ITT). In case of the standard therapy with Dacarbazine the 1-year-survival rate is usually about 30% and the mOS between 6 and 8 months, respectively. The majority of treatment-related adverse events were not severe application site reactions and pruritus.
The skin reactions appeared in 70% of the patients seem associated with the efficacy of the drug. Thus the 1-year-survival rate of 62% and the mOS of 15 months are in these patients much higher compared to the total study group. Patients without any skin reactions due to the injection of the drug apparently failed to prove the clinical benefit.
“The results clearly suggest that ME-503 is active in patients with metastatic melanoma, and they add to our evidence that the compound has great potential as a highly active immunotherapeutic,” said Hans Lentzen, CSO of MELEMA. “We see activity in all grades of metastatic melanoma, in particular in repeatedly pretreated melanoma patients.”
“More than 70% of the patients in this trial were suffering from the most severe stage IV M1c metastatic melanoma,” said the principle investigator of the trial, Dr. Peter Mohr from the Elbe Klinikum Buxtehude, Germany, upon completion of the study report in March 2011. “These patients already have developed distant metastases, e.g. in the liver, have an elevated lactate dehydrogenase level and have experienced previous treatments. The results of this trial therefore are very encouraging and require confirmation in a large randomized phase III trial. Furthermore, the subcutaneous application of the drug is of advantage for allowing an outpatient treatment and has shown a good compliance.”