Clapper, Patti, Schweizer and Mason

MolMed, an Italian biotechnology company, has been working on a novel treatment for mesothelioma for years, having shifted gears into Phase III clinical trials in 2011.  Now their drug, NGR-hTNF, has been granted a patent covering the therapeutic use of NGR-hTNF by the European Patent Office.  This will allow the drug company to further expand their research and proceed to the next phase of testing.  Indeed, this may mean that the new drug will shortly be submitted for approval by the European Medicines Agency (Europe’s equivalent to the Food and Drug Administration (FDA) here in the United States.)

The Phase III trials are testing the effectiveness of the drug as a treatment for “relapsed” mesothelioma – meaning mesothelioma that has recurred after other traditional forms of treatment have been administered.  In addition, there are ongoing Phase II clinical trials testing the drug’s effectiveness as a first-line maintenance treatment for pleural mesothelioma patients who have undergone chemotherapy. 

NGR-hTNF targets the vascular development of tumors, thereby inhibiting their growth and inducing cell death.  It is the first drug designed to utilize peptide/cytokine complexes in order to specifically target blood vessels feeding cancer tumors without attacking those feeding healthy tissues.  Though targeting the vascular structures of tumors is not a new idea, the MolMed drug is the first to have displayed significant selectivity and effectiveness using this method of therapy against pleural mesothelioma.

The patent allows NGR-hTNF to be marketed with exclusivity (meaning no generics or competitive drugs can be created) in 38 European countries.

MolMed has also filed 11 similar patent applications in various international drug markets including the United States, Japan, Canada, Australia and China.  Not coincidentally, these countries are those in which asbestos use was the most widespread and mesothelioma rates are the highest.  While rates are predicted to slowly decline in the U.K. and the United States in the near future, countries like Australia which have just recently banned the commercial use of asbestos or those like China in which it’s use is poorly regulated are expected to suffer higher rates into the foreseeable future.

Indeed, MolMed is predicting that because of the long latency period associated with mesothelioma that the rate of new diagnoses will continue to rise worldwide for at least the next 10 and possible the next 20 years. 

Researchers are hopeful that the results of these clinical trials will persuade officials at the FDA to approve NGR-hTNF for use in the United States.

Source:  The European Patent Office Grants MolMed a New Patent on Its Anticancer Drug NGR-hTNF