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Orphan drug increases survival of mesothelioma patients significantly, researchers report


Italian researchers say that patients with recurring pleural mesothelioma who were treated with an experimental drug called NGR-hTNF survived five times longer than a control group.


NGR-hTNF is a vascular targeting agent that consists of a tumor homing peptide (NGR) and a tumor killing agent (TNF). The drug, which is being tested alone in patients and in combination with other drugs, shrinks tumors by disrupting their ability to form blood vessels.


The drug is being developed by MolMed, an Italian biotechnology company that is also testing NGR-hTNF in patients with non-small-cell lung cancer, soft tissues sarcomas, liver cancer, ovarian cancer and colorectal cancer.


The new data on pleural mesothelioma, presented this week at the 2012 meeting of the American Society of Clinical Oncologists, reports on a three-year follow-up of 57 patients who participated in a Phase II clinical trial completed last year.


According to an abstract, the patients were given NGR-hTNF either every three weeks or once a week after relapse following pemetrexed-based chemotherapy. The researchers report that survival rates of patients on the “dose-dense schedule” are five-fold higher than patients who received a placebo.


Claudio Bordignon, MolMed’s Chairman and CEO, said more than 200 patients have been recruited for a Phase III trial of NGR-hTNF at 40 cancer centers in Europe and the United States. The research is the only active trial of a so-called second-line treatment for mesothelioma.


The U.S. arm of the clinical trial began after the U.S. Food and Drug Administration granted orphan-drug status to NGR-hTNF. Orphan drugs are treatments for rare diseases that affect fewer that 200,000 people in the U.S. The FDA’s designation offers pharmaceutical companies who develop orphan drugs certain incentives, such as tax breaks, aimed at helping the drug gain regulatory approval.