Mesothelioma, In the US a new Orphan Drug for the Treatment of Neoplasia

It is BAY 94-9343, an experimental anticancer agent

A new orphan drug for the treatment of mesothelioma. It is BAY 94-9343, an experimental anticancer agent produced by Bayer HealthCare, which has obtained the status of an orphan drug by the Food and Drug Administration. It is an experimental drug currently in clinical development.

The drug is an ADC (in drug conjugated antibodies) that combines the targeting properties of an antibody with the effect cellular destruction of a small and powerful molecule of the cytotoxic agent.

BAY 94-9343 (mesothelin-ADC) is an antibody-conjugated drug that targets mesothelin, molecule highly expressed in mesothelioma. It is a drug that ultilzza an entity fully human antibody, generated thanks to the technology of HuCAL Morphos Platform.

The drug has been shown to have a powerful and targeted anti-cancer activity in preclinical studies.

In September 2011 it has started patient enrollment for a Phase I open-label to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug. Patients are currently treated with BAY 94-9343 at three research centers in the United States (Maryland, Tennessee and Texas). For more information on this study (NCT01439152), you can visit the website www.clinicaltrials.gov.

"This is an important step in the development process of this investigational drug," said Prof. Andreas Busch, member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery. "Malignant mesothelioma is a rare type of cancer with a poor prognosis. C 'is a significant unmet medical need for these patients. Bayer therefore undertook to develop a therapy that can help people with this cancer to live longer longer, improving the quality of their lives. "

Recall that mesothelioma is a rare tumor, which represents less than 1 percent of all cancers. It develops from the cells of the mesothelium, the thin protective membrane that surrounds the large serous cavities of the human body. Malignant pleural mesothelioma is the most common form of mesothelioma.

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