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New Drug for Mesothelioma Receives Orphan Drug Status

The makers of a biologic therapy that has already been used in the treatment of a variety of other cancers have just announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. This means that the company will be able to have certain benefits, including seven years of U.S. market exclusivity in its application of treating mesothelioma, as well as tax credits and possible exemptions of certain fees.

The new drug is called MTG-201, and it targets specific gene defects in cancer. The therapy detects and targets Dickkopf-3 genes, which produce a produce that – when absent – allows cancer cells to continue to live instead of being killed by other cancer therapies. When genes have the Dickkopf-3 genes are defective, the cancer cells can’t die, and the patient’s disease progresses. MTG-201 is under investigation for the treatment of mesothelioma, as well as for the treatment of prostate cancer, and the company that makes it, MTG Biotherapeutics (MTG) is in the early stages of testing it for the treatment of liver and bladder cancer.

The process that MTG-201 is a part of is extremely complex, but what it does is enter the cancer cells that have the defect and causes cell death. This reduces the number of mesothelioma cells that are alive in the patient in much the same way that T-cell lymphocytes do, and may lead to an entirely new line of treatment.

Because mesothelioma is such a rare drug, it is not in the economic interest of drug manufacturers to invest a lot of money into developing new drugs. In recognition of the fact that this type of situation would work against treatments being created for rare diseases, the federal government established Orphan Drug designation to provide manufacturers with an incentive to continue seeking cures.

Speaking of his company’s product, Richard Lowenthal, CEO and President of MTG, said, “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. MTG-201 represents a very novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer. MTG has already demonstrated that ability of MTG-201 to induce selective apoptosis in Phase 1 studies for prostate cancer, another cancer immortalized by hypermethylation of the Dickkopf-3 gene. Mesothelioma has been found to be the most sensitive cancer to this mechanism of action and as such we are moving MTG-201 into Phase 1 development for this indication.”

Terri Oppenheimer

Terri Oppenheimer is an independent writer, editor and proofreader. She graduated from the College of William and Mary with a degree in English. Her dreams of a writing career were diverted by a need to pay her bills. She spent a few years providing copy for a major retailer, then landed a lucrative career in advertising sales. With college bills for all three of her kids paid, she left corporate America for a return to her original goal of writing. She specializes in providing content for websites and finds tremendous enjoyment in the things she learns while doing her research. Her specific areas of interest include health and fitness, medical research, and the law.

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