The Food and Drug Administration (FDA) granted orphan drug status to a new mesothelioma drug this month. MTG-201 is an immunotherapy drug developed by MTG Biotherapeutics, a company that specializes in developing new immune-system based cancer treatments.

“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, CEO and President of MTG, said in a press release this month.

Researchers expect MTG-201 to be especially effective in treating mesothelioma but are also studying it for use in treating other types of cancer.

Why is Orphan Status Important?

MTG-201 gaining orphan drug status is great news for mesothelioma patients for a lot of reasons. The most important of those reasons being that this means the FDA believes this drug may be a safe and effective treatment. This status also means the company working on the drug gets certain perks to help with the development and improvement of the drug.

The Orphan Drug Act allows the FDA to grant orphan drug status to treatments for rare diseases (affecting less than 200,000 people in the U.S.).

This is so that they can get the support needed to perfect the treatment.

Some of the benefits that MTG could be getting now include US market exclusivity, tax credits for clinical trial expenses and exemption from certain FDA fees.

Understanding MTG-201

Immuno-oncology is an up-and-coming field as researchers discover ways to convince our immune systems to fight off mesothelioma. Mesothelioma cells exist because they managed to become immortal.

Our body’s healthy cells naturally die when they realize they are supposed to, this natural suicide is called apoptosis. Cancer cells do not undergo apoptosis and continue living and multiplying.

A lot of the new mesothelioma treatments, including MTG-201, focus on convincing the cancer cells to kill themselves like a normal cell would. MTG-201 focuses on the Dickkopf-3 gene, which is important because it releases a protein called REIC (Reduced Expression in Immortalized Cells).

Mesothelioma cells are deficient in the REIC protein. The treatment is based on expressing REIC from within the cells, this protein then signals mesothelioma cells that it’s time to die (apoptosis). MTG-201 also improves immune response through T-cell stimulation. T-Cells play an important part in our immune system.

MTG-201 uses the T-cells by prompting them to attack the residual cancer cells once the cancer starts dying. Doctors are also combining MTG-201 with other immunotherapy drugs to improve treatment.

“MTG-201 represents a very novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer,” Richard Lowenthal said.

MTG-201 is in Phase I clinical trials. These trials will help to prove if MTG-201 can safely improve survival rates for mesothelioma in patients.

Guide Packet Desktop Ad

Want to learn more?

Try Our Free Guide to Fighting Mesothelioma

Get in depth knowledge about your diagnosis & the best treatments.

Learn More
Guide Packet Mobile Ad

    Sources & Author

Picture of Jamie Iovino

About the Writer, Jamie Iovino

Jamie Iovino is the senior writer at Mesothelioma Guide. She creates and edits pages to make sure mesothelioma patients and their families receive the newest and most accurate information about mesothelioma.