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FDA grants orphan drug designation to MTG-201 for malignant mesothelioma
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The FDA granted orphan drug designation to MTG-201 for the treatment of patients with malignant mesothelioma, according to a press release.
MTG-201 (MTG Biotherapeutics) is an advanced biologic therapy that targets Dickkopf-3 gene defects in various cancer types. The Dickkopf-3 gene produces the REIC protein, without which cancer cells can not die.
MTG-201 directly attacks mesothelioma cancer cells and induces immune system response, and may be used in combination with anti–CTLA-4 therapies in development for the disease.
In addition, MTG-201 is under development for the treatment of prostate cancer, and ongoing preclinical programs are evaluating MTG-201 as a potential treatment for liver and bladder cancers.
"There is a significant need for new treatment options for patients with mesothelioma given this is one of the most aggressive and poorly treated cancers,” Richard Lowenthal, president and CEO of MTG Biotherapeutics, said in a press release. “MTG-201 represents a very novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer.”
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.