Bayer HealthCare has announced that its investigational anti-cancer agent BAY 94-9343, a mesothelin-targeting antibody-drug conjugate ( ADC ), has been granted orphan drug status for the treatment of patients with mesothelioma by FDA ( Food and Drug Administration ).
This investigational agent is currently in Phase I clinical development.

In September 2011, Bayer started the enrollment of patients in an open label Phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 94-9343 for the treatment of patients with advanced solid tumors. Patients are currently treated at three study Centers in the U.S. ( Maryland, Tennessee, and Texas ).

BAY 94-9343 ( Mesothelin-ADC ) is an antibody-drug conjugate directed against the target molecule mesothelin which is highly expressed on mesotheliomas and on other cancers, e.g. many ovarian and pancreatic tumors.
BAY 94-9343 has demonstrated potent, targeted anti-cancer activity against mesothelin-expressing tumors in preclinical models.

Malignant mesothelioma is a rare type of cancer. It develops from transformed cells originating in the mesothelium, the protective thin membrane encompassing the body's internal organs and cavities. There are three recognized forms of malignant mesothelioma: Pleural mesothelioma is the most common type of the disease ( roughly 70% of all cases ) and occurs in the outer lining of the lungs and internal chest wall, peritoneal mesothelioma occurs in the lining of the abdominal cavity, and pericardial mesothelioma originates in the pericardium.

Malignant mesothelioma is usually caused by exposure to asbestos and the inhalation of asbestos particles. Inhaled or ingested asbestos fibers may cause an inflammation of internal tissue and disrupt organ function leading to the development of mesothelioma. In most cases, the symptoms of mesothelioma such as shortness of breath, lower back pain or side chest pain will only appear years after exposure and are frequently ignored or dismissed. Malignant mesothelioma is extremely aggressive and due to a long latency period cases are often not detected until the disease has reached advanced stages. As a result the prognosis for patients is poor, despite treatment with radiation therapy, chemotherapy and surgery. The survival rate of mesothelioma following diagnosis is usually about two years depending on type, location, and stage.

Source: Bayer HealthCare, 2012

XagenaMedicine2012