FDA Clears Path for Promising Mesothelioma Drug Research

A drug developed by a San Diego, California, company to fight prostate cancer turns out to be even more effective against mesothelioma.

As a result, the U.S. Food and Drug Administration (FDA) in August granted the medication what’s known as orphan drug status. That could be very good news for doctors and patients eager to access additional mesothelioma treatment options.

The drug that has gained orphan status is called MTG-201. The company that makes it is MTG Biotherapeutics.

MTG-201 is an advanced biologic therapy that targets the Dickkopf-3 gene defect. According to the company, the Dickkopf-3 gene produces a protein called REIC. REIC stands for Reduced Expression in Immortalized Cells.

REIC is a vital part of apoptosis. Apoptosis refers to the process by which damaged or mutant cells self-destruct so that they don’t end up damaging or mutating neighboring healthy cells.

Unfortunately, cancer cells have the ability to deactivate the mechanism that creates REIC. No REIC, no apoptosis. No apoptosis, no stopping the growth of the cancer cells.

MTG-201 Pushes Mesothelioma Cells into Apoptosis

MTG-201 solves that problem by triggering apoptosis. It accomplishes this trick by inducing the cancer cells to generate REIC.

More specifically, what MTG-201 does is it seeks out cancer cells immortalized by hypermethylation of the Dickkopf-3 gene. Those are the ones that are REIC protein deficient.

“By expressing REIC protein from within cancer cells, MTG-201 induces selective apoptosis due to ER stress, thus directly killing the cancer and reducing cancer burden,” the company explains.

But that’s not all. MTG-201 also stimulates production of activated T-cell lymphocytes. These then sweep in to destroy cancer cells that somehow manage to escape the command to self-destruct.

The company says this secondary effect suggests that MTG-201 might be able to synergistically work with checkpoint inhibitors.

“MTG-201 is also being evaluated for efficacy in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 antibodies,” the company reveals.

When Mesothelioma Drugs Win Orphan Status

Orphan drug status is given to drugs and biologics that show promise for the treatment diagnosis, or prevention of rare diseases or disorders.

By rare, the FDA means it can’t affect more than 200,000 Americans. Mesothelioma qualifies because there are only about 30,000 active cases of it in the U.S. at any given time.

Orphan status carries with it benefits for the maker of the drug. Those benefits translate into incentives to press full-speed ahead with research. For example, the maker gets tax credits to help pay for clinical trials.

The maker also becomes eligible for exemption from FDA application fees. Further, the maker is given seven years to exclusively market the drug.

That means the maker can concentrate on getting the science right, rather than putting all its energies and brainpower into outwitting marketplace rivals.

MTG Biotherapeutics believes there is a great need to develop therapies such as MTG-201 that can directly attack the mesothelioma cancer cells and induce the immune system against the cancer.

MTG Biotherapeutics is a privately held biopharmaceutical company. Its focus is novel biologic technologies. MTG-201 was developed from discoveries made by researchers at Okayama Medical Hospital in Japan.