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What is the study drug?

What is the study drug?

 
The study involves the use of an investigational agent (rAd-IFN) given with celecoxib and gemcitabine.

What is the rAd-IFN?

rAd-IFN is an investigational agent, a type of gene therapy, that may help treat malignant pleural mesothelioma (MPM).

What does “investigational agent” mean?

rAd-IFN is considered an “investigational agent” because it is still being studied. The United States Food and Drug Administration (FDA) and other regulatory authorities do not allow rAd-IFN to be sold for treating patients. This agent is only allowed to be used in research.

How does rAd-IFN work?

This investigational agent is designed to help your body produce more of a protein called interferon, specifically in the lining of your lungs. The increased amount of this protein can stimulate your immune system and may decrease the growth of your tumor.

Have other people used rAd-IFN?

Yes, people have used rAd-IFN for MPM in other clinical research studies:
  • In an initial pilot study, 11 patients with MPM received rAd-IFN to determine the appropriate dose.
  • In another study, 40 patients with MPM received rAd-IFN in combination with celecoxib, followed by standard first-line or second-line chemotherapy. Overall, rAd-IFN was well-tolerated.
The INFINITE study focuses on the effectiveness of rAd-IFN compared to standard chemotherapy alone.

What are celecoxib and gemcitabine?

The other drugs in the study are celecoxib and gemcitabine. Celecoxib is a nonsteroidal anti-inflammatory drug. Gemcitabine is a chemotherapy treatment. While both of these drugs are approved to treat patients with a variety of conditions, the use of celecoxib and gemcitabine with rAd-IFN is an “investigational” treatment for MPM.


 

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