A Phase III trial of NGR-hTNF is expanding soon into the United States, raising hopes in the battle against malignant pleural mesothelioma.
The trial is ongoing in Europe and will be moved into another 40 centers worldwide, according to manufacturer MolMed, which started the trial in Milan, Italy.
NGR-hTNF is a vascular targeting agent that seeks out tumor cells and disrupts their blood vessel formation, causing them to shrink.
The drug is being tested as a single therapy and in combination therapy. It is a two-part drug that consists of a tumor homing peptide (NGR) and a tumor killing agent (TNF).
“This expansion is a very important step in the clinical development plans,” said MolMed chairman Claudio Bordigan, in a statement Tuesday. “The trial is intended to assess the clinical efficacy of our investigational drug as second-line treatment for patients after chemotherapy.”
The trial that is coming to the United States will investigate the administration of either NGR-hTNF or a placebo in addition to the best secondary choice that could include one chemotherapeutic agent or supportive care alone. The randomization ratio will be 1:1, according to researchers.
The drug, or placebo, will be administered intravenously at one-hour infusions. The supportive care, or chemotherapy, will be given as the standard clinical rates.
The trial moved out of Italy and into Europe in February. Results are expected in 2013. The U.S. trial start follows clearance by the FDA, which previously approved NGR-hTNT only for Orphan Drug approval.
The Orphan Drug approval is designed for products to treat rare diseases. It allows a manufacturer to exclusively market a drug for seven years, providing a financial incentive to pharmaceutical companies to research drugs with limited marketability.
Mesothelioma is rare cancer caused by an exposure to asbestos and is diagnosed in an estimated 3,000 people annually in the United States. By comparison, there are more than 200,000 cases of breast cancer and prostate cancer diagnosed each year.
There is no known cure for mesothelioma and a typical diagnosis comes with a survival rate of less than two years.
MolMed is a biotechnology company that focuses on research and development of antitumor therapies. MolMed has Phase II Trials of NGR-hTNF in regard to non-small-cell lung cancer, soft tissues sarcomas, liver cancer, ovarian cancer and colorectal cancer.