Mesothelioma Phase II Clinical Trial for New Drug

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» MORAb-009
» Goals of the Clinical Trial
» Treatment Centers

Historically, cancer has been treated with drugs that inhibit the inner workings of cells. Many of these treatments, including chemotherapy medications, can have devastating side effects due to the fact that they also interrupt the processes of non-cancerous cells. Gene therapy research is aimed at developing treatments to overcome this obstacle by targeting the specific proteins that cause cells to mutate and become cancerous.

Information on Enrollment

The clinical trial will be conducted at treatment centers around the world and is limited to people suffering from malignant mesothelioma who have not yet received treatment. Initially, the study will involve 33 people, but depending on preliminary results up to 78 participants may eventually be enrolled. Updated information can be obtained at clinicaltrials.gov or by contacting Dr. Raffit Hassan, Chief of Solid Tumor, Immunotherapy Section, Laboratory of Molecular Biology at the National Cancer Institute at 888-422-4743.

Mesothelioma occurs when a protein or set of proteins allow cells to grow in an uncontrolled manner. One such protein called mesothelin was found by researchers looking for differential expression of proteins between normal cells and mesothelioma cells. The increased presence of mesothelin on certain cells is thought to enable their growth and spread (metastasis), leading to cancers such as mesothelioma and pancreatic cancer. As a result, much of the mesothelioma research currently underway is focused on developing gene therapies or biopharmaceutical products that can directly block mesothelin function. In March 2009, biopharmaceutical company Morphotek announced the commencement of a Phase II clinical trial to evaluate MORAb-009 as a new therapeutic approach to treat mesothelioma. MORAb-009 is a monoclonal antibody — a replica of an antibody produced by the human body normally used to fight infectious disease.

Why MORAb-009?

The company's decision to move forward with its study of MORAb-009 was made after results in preclinical studies involving animals showed a slowing of tumor growth when combined with chemotherapy. Mesothelioma patients in the Phase I trial tolerated the treatment well, with minimal side effects. As a class, antibodies are generally well tolerated.

MORAb-009 is a monoclonal antibody that tackles mesothelioma in two ways: by stimulating the body's immune system and by blocking the function of mesothelin. Monoclonal antibodies are a relatively new type of therapy cancer treatment. They are developed by identifying antibodies known to have a specific purpose and adapting them in the laboratory in such as way as to develop the exact characteristics needed to attack the proteins causing or involved in maintaining the disease.

Goals of the Clinical Trial

The MORAb-009 study is designed to provide patients with mesothelioma therapy that goes beyond the normal standard of care. Participants will receive a mesothelioma treatment consisting of MORAb-009 in combination with chemotherapy drugs Alimta (pemetrexed for injection) and cisplatin. The company's objectives are twofold: to assess the efficacy of MORAb-009 and to gain further evidence of its safety.

The company is hopeful that patients will be able to continue taking MORAb-009 for a matter of months, if not longer. While the scheduled treatment duration is one year, patients will have access to the treatment for as long as they respond to the therapy and need treatment. The entire clinical trial is scheduled to last approximately four years. After the first 33 patients enroll, the company along with expert independent oncologists will determine if their response was any better than would be expected for patients taking Alimta and cisplatin alone. If that is the case, an additional 45 patients will enroll in order to give the study statistical power to demonstrate efficacy.

Treatment Centers

Mesothelioma is a fatal form of cancer affecting the lining of body cavities; most frequently the chest (pleural mesothelioma), but the abdomen (peritoneal mesothelioma) and occasionally the heart (pericardial mesothelioma) are affected. At present time, the prognosis of mesothelioma patients is quite grim: 60 percent of patients die within one year of diagnosis. This is why studies such as the MORAb-009 clinical trial are so important. Patients diagnosed with mesothelioma should carefully weigh all options with their doctors to determine whether or not to participate in a clinical trial.

The treatment centers currently planning to participate in Morphotek's clinical trial are located in the U.S., Canada, Germany, Spain and the Netherlands, and additional treatment centers may be added. For the latest information on the MORAb-009 clinical trial and participating treatment centers, visit www.clinicaltrials.gov and type in: NCT00738582 or contact: 1-888-522-4743.

[Page updated April 2009]