The developers of an FDA-designated ‘orphan drug’ for mesothelioma are recruiting patients for a new Phase II clinical trial on soft tissue sarcomas. The drug, called NGR-hTNF is a vascular targeting agent that appears to be able to seek out tumor cells in the body and disrupt their blood vessel formation. An orphan drug is a medicine that has been developed specifically to treat a rare medical condition, such as mesothelioma or liver cancer. The new clinical trial will test NGR-hTNF’s effectiveness against certain soft tissue sarcomas alone or in combination with the drug doxorubicin.
In addition to the newly-announced clinical trial, the drug’s manufacturer, Italy-based MolMed S.p.A, has also been conducting Phase III clinical trials specifically in malignant pleural mesothelioma. NGR-hTNF has already shown promise in completed Phase II clinical trials for mesothelioma, liver cancer and colorectal cancer and it is currently also being tested for small-cell lung cancer and ovarian cancer.
Malignant pleural mesothelioma is a cancer that begins in the pleura or lining that surrounds the lungs. It is almost always the result of exposure to asbestos. According to recent studies, fibers of the mineral can migrate into the pleura when inhaled, setting up an inflammatory response that can eventually lead to cancer. About 3,000 people in the U.S. are diagnosed with mesothelioma every year. It is notoriously difficult both to diagnose and treat.
Because it combines a peptide (NGR) with a cytokine (TNF), the NGR-hTNF treatment is classified as a peptide/cytokine complex. Its effectiveness is being evaluated both alone and in combination with other types of therapies to treat malignant pleural mesothelioma and other rare diseases.
In a recent company press release, CEO Claudio Bordignon commented “We now have evidence of clinical activity of NGR-hTNF in five different types of solid tumors, adding two more indications, ovarian and small-cell lung cancer to those observed in completed Phase II trials as a single agent in colorectal cancer, liver cancer and mesothelioma.” High doses of the drug have also been shown to be effective for certain kinds of tumors in the arms and legs.
NGR-hTNF holds orphan drug status in both the U.S. and the European Union for mesothelioma and liver cancer. Results of the latest clinical trials were recently presented at the annual meeting of the European Society of Medical Oncology in Milan.
“MolMed starts a randomized Phase II trial of NGR-hTNF in a new indication, soft tissue sarcomas”, Drugs in Development, PharmaLive website. Accessed October 28, 2010. “First results of three clinical trials of NGR-hTNF presented at ECCO-ESMO 2010”, Drugs.com website. Accessed October 28, 2010. “NGR-hTNF, a novel vascular targeting agent (VTA), as second-line therapy in malignant pleural mesothelioma (MPM): Preliminary results of multicenter phase II study.” American Society of Clinical Oncology website. Accessed October 28, 2010.