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  • Home > Blog > Clinical Trial > Italian Clinical Trial for Malignant Pleural Mesothelioma Expands into United States
Posted on Tuesday, Mar 1, 2011

Italian Clinical Trial for Malignant Pleural Mesothelioma Expands into United States

MolMed S.p.A., an Italian biotechnology company focused on research, development and clinical validation of novel antitumor therapies, has announced the expansion of their Phase III trial of its investigational anticancer drug NGR-hTNF for the treatment of malignant pleural mesothelioma.  10 centers in Italy are conducting the trial, and it will now be expanded throughout Europe and the United States.  Clinical trials are critically important to find new treatments and cures for cancers, such as mesothelioma, an asbestos-related pulmonary cancer.

A clinical trial is one of the final stages of a long and specific cancer research process.  Studies are conducted with patients to determine whether a new approach to cancer prevention, diagnosis, and/or treatment is safe and effective.  They are also used to help doctors and pharmaceutical companies find ways to improve a mesothelioma patient’s health and cancer care.

MolMed expects to enroll 390 patients diagnosed with malignant pleural mesothelioma who have previously been treated with standard pemetrexed-based chemotherapy, yet the disease continued to progress.  The focus of the study is for overall survival, progression-free survival, disease control rate, safety, and patient quality of life.  They expect top-line results to be released in 2013.

MolMed identifies NGR-hTNF as a vascular targeting agent with unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumor vasculature. It consists of a tumor homing peptide (NGR) that selectively binds tumor blood vessels, fused to the human cytokine TNF.

NGR-hTNF has been granted Orphan Drug designation – in both the EU and the US – for the treatment of mesothelioma and of liver cancer. In the United States an “orphan disease” status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time.

For the 3,000 Americans diagnosed with mesothelioma each year, clinical trials may offer the best available treatment as well as the opportunity to receive new, potentially more effective therapies.    There are risks associated to clinical trials of which participants should be aware.  Primarily, the experimental treatment may not be effective for the patient, or the patient could have a serious or life-threatening side effect.

To find a list of clinical trials related to mesothelioma see ClinicalTrials.gov.

Mesothelioma Clinical Trial