Clinical Trial of Experimental Mesothelioma Drug Promising

Researchers announced positive results from tests of an experimental anti-cancer drug known as NGR-hTNF in controlling the cancer of patients with malignant pleural mesothelioma. Mesothelioma is an incurable cancer of the lining of the lung associated with asbestos exposure.

NGR-hTNF is a novel drug compound that includes a peptide—a chain of amino acids—that homes in on cancer cells—and a type of protein known as tumor necrosis factor that helps regulate the immune system response to cancerous tumors. Developed by an Italian pharmaceutical company, MolMed S.p.A., the drug is designed to better permeate cancerous tumors and act directly on blood vessels that feed a tumor’s growth.

In an article published this week in the Journal of Clinical Oncology, Italian researchers said NGR-hTNF was given to 57 mesothelioma patients either every three weeks or every week. The patients had previously undergone chemotherapy and had a relapse. The results showed the drug temporarily stopped the advance of the cancer in 26 patients for about five months on average. Median survival was 12 months.

The researchers said the disease control provided by NGR-hTNF and patients’ ability to tolerate the drug warranted further study with patients with advanced pleural mesothelioma.

The drug is being studied as an alternative treatment for patients whose cancer is not responding to the more standard chemotherapy regimen involving permetrexed. A phase III clinical study is underway. Researchers are exploring it use by itself or in combination with other medications.

On the basis of the latest results, the drug was granted orphan drug designation for treatment of malignant mesothelioma in the United State and in Europe, MolMed S.p.A., announced.

The federal Orphan Drug Act provides special status to drugs used to treat a rare disease or condition at the request of the drug sponsor. MolMed S.p.A., an Italian pharmaceutical company, is developing the drug. The orphan designation provides tax credits and government incentives to sponsors that bring develop drugs to treat rare diseases. About 2,000 to 3,000 people die of mesothelioma in the United States each year, but incidence of the disease has increased significantly in recent decades.

The drug must go through the Food and Drug Administration marketing approval process like any other drug. Orphan drugs often receive expedited review because they are for serious or life threatening diseases, according to the Food and Drug Administration.