MolMed S.p.A. (MLM.MI) announces today receipt of the official notification from the European Patent Office of the decision to grant a patent covering the therapeutic use of its investigational anticancer drug NGR-hTNF at low doses. The grant will take effect on the 2nd of October 2013, when it will be published in the European Patent Bulletin.
The administration of NGR-hTNF at low doses is being investigated in a vast clinical program, including a Phase III trial in malignant pleural mesothelioma and several Phase II trials in colorectal, lung, liver and ovarian cancer, and soft tissue sarcomas. MolMed recently presented at the annual ASCO (American Society of Clinical Oncology) congress the final results of the randomised Phase II study in NSCLC patients with squamous histology, and the preliminary results of the Phase II trial in soft tissue sarcomas.
The studies confirmed both the efficacy and the favourable safety profile of the low doses NGR-hTNF treatment. This new European patent on NGR-hTNF (EP1499730) becomes part of a large proprietary patent family which comprises 7 granted patents and 3 patent applications filed in the most important pharmaceutical markets, including the United States, Japan, Canada, Australia and China. The patent will afford protection until 2023 and will give right to market exclusivity in 27 European countries, including European Union member states, Eastern Europe countries, Switzerland and Turkey.
MolMed herewith further strengthens its patent portfolio on NGR-hTNF, consisting of seven patent families, which includes 146 granted patents and 32 pending applications, covering the following elements: product, production vector, targeting technology, synergistic combinations with other anticancer drugs, the use at low doses, therapeutic indications and specifically the treatment of mesothelioma.
Claudio Bordignon, Chairman and CEO of MolMed, commented: “This new European patent, covering the therapeutic use of NGR-hTNF at low doses, further reinforces MolMed’s extended market exclusivity on the drug and is of remarkable relevance, as it expressly covers the dose used in the clinical trials. The selectivity of action associated to the use of low doses is indeed one of the key advantages of our product: in terms of efficacy, since low concentrations do not induce counter-regulatory mechanisms, and in terms of high tolerability”.
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 a Phase III trial in malignant pleural mesothelioma and Phase II trials in six indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas.
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)