MolMed, new data presented at the European Cancer Congress show a statistically significant increase in survival of patients suffering from soft tissue sarcomas treated with NGR-hTNF.
MolMed S.p.A. (MLM.MI) presented at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in Amsterdam (The Netherlands), additional data from an ongoing randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF on patients suffering from soft tissue sarcomas. Data show the impact of the weekly administration of NGR-hTNF at low doses (0,8μg/sqm) in combination with doxorubicin.
Presentation: “NGR-hTNF given at low dose or high dose with or without doxorubicin in soft-tissue sarcomas”
The new data highlighted a statistically significant doubling of the median survival associated to a favourable tolerability profile. Of particular interest is the evidence that efficacy and tolerability were similar both in patients untreated or resistant to prior treatments.
Claudio Bordignon, Chairman and CEO of MolMed, commented: “These additional results from a randomised Phase II study are relevant for two reasons: on the one hand they confirm the previously observed effectiveness of NGR-hTNF in various cancer indications; on the other hand they validate the choice of the weekly schedule of low doses administration, as already demonstrated in the treatment of malignant pleural mesothelioma, currently in Phase III clinical trial”.
Randomized Phase II study of NGR-hTNF in soft tissue sarcomas
This four-arm trial was designed to select the best NGR-hTNF regimen for patients with sarcomas. The primary aim of achieving a doubled three-month progression-free rate (40% vs 20%) was met by the combination of low-dose intensified NGR-hTNF (0.8 μg/sqm weekly) with doxorubicin, after both the first and the second trial stages.
Preliminary data presented in June at the 49th annual meeting of the American Society of Clinical Oncology (ASCO) also show that the superiority of this regimen over the other ones in terms of progression-free survival (with a three-fold increased median duration) translated into an analogous advantage in terms of overall survival (with a two-fold increased median time).
NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass. NGR-hTNF is being investigated in a large clinical program, including Phase II trials in six indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas and a pivotal Phase III trial in malignant pleural mesothelioma: based on the trial follow-up evolution, results are now expected to be available between December 2013 and January 2014.
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells.MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)