MolMed S.p.A., a biological research firm based in Milan, Italy, stated that they have begun Phase III trials on their new mesothelioma drug. Scientists recently concluded Phase II trials of the drug, called NGR-hTNF, on patients suffering from the disease, which affects the soft tissue surrounding the lungs. Treatment choices for the disease currently do not provide patients with a cure, but act as a method to ease pain and suffering while attempting to reduce and manage tumors.
Researchers expect to have as many as four hundred patients participate in the latest phase of the clinical trials. Most of these patients have undergone a chemotherapy routine based around the drug pemetrexed (brand name: Alimta). Patients who take part in the study will receive NGR-hTNF in combination with other proven chemotherapy drugs, such as vinorelbine, doxorubicin and gemcitabine.
The purpose of the trial will be to test how patients respond to the new treatment regimen. Scientists will record the rate of the disease’s progression in patients during the treatment cycle as well as their quality of life and the appearance and severity of any side effects related to the new drug. Chemotherapy patients routinely experience side effects such as vomiting, nausea, loss of appetite and alopecia (hair loss) while undergoing treatment.
MolMed Chief Executive Officer Claudio Bordignon expressed his optimism at the new phase of clinical trials. He called the Phase III trials an “important milestone” in the progress of the NGR-hTNF treatment method. He said that, if successful, the new drug would meet a “very high unmet medical need”. Due to the outstanding results the drug achieved in Phase II trials, Mr. Bordignon said that the Phase III trial would be “optimally designed” to explore the “full therapeutic potential” for patients with mesothelioma.
The study will be a double-blind investigation. Researchers will randomly assign half of the patients enrolled in the study to receive the combination of NGR-hTNF and another chemotherapy drug. The other half will receive a placebo plus one of the other chemotherapy agents. Patients will receive either NGR-hTNF or the placebo once a week and the other selected chemotherapy drug according to its regular schedule. No date has been set for the conclusion of the study, but researchers expect to see results within two to three years.
The success of the Phase II trials has allowed NGR-hTNF to gain “orphan drug” status from the US Food and Drug Administration. An “orphan drug” is a drug that has been created to target a specific disease. Companies that develop orphan drugs often receive tax breaks or research grants, since the costs of developing such drugs are quite high and the expected revenue from such a small population sample would not offset those costs.
NGR-hTNF has also shown successful Phase II trials in treatments for other forms of cancer. Other trials have shown the drug to be an effective treatment, either by itself or in combination with other chemotherapy drugs, for ovarian cancer, colorectal cancer, and certain types of lung cancer.
Mesothelioma, which occurs most often as malignant pleural mesothelioma, around the lungs, is an incurable form of cancer that lies dormant for up to five decades. That is, it produces few symptoms, and those few are indistinguishable from other chronic but nonfatal diseases like asthma, chronic obstructive pulmonary disease, immune system failures and even chronic bronchitis. When mesothelioma does begin producing symptoms severe enough to force sufferers to see a doctor, it is already too late, and most doctors are forced to provide a prognosis of one year to live.
