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Nanotechnology Targets Mesothelioma; FDA Keeps Watchful Eye on Developments


testThe latest emerging medical technology, nanotechnology, has heralded myriad breakthroughs in the development of novel therapies for orphan diseases and cancers. Mesothelioma researchers have started focusing on using nanotechnology to deliver cancer-fighting drugs directly to cancerous cells, thus, leaving healthy cells intact.

The infinitesimal size of nanoparticles – the size of one-billionth of a meter – allows payloads of drugs to home in on tumors while minimizing side effects from toxicity due to excess medicine that is currently needed to effectively attack cancer cells. Most often, capsules, referred to as “magic bullets,” are developed to deliver the medicines directly to the targeted cells.

In an article in FDAVoice, the U.S. Food and Drug Administration’s blog site, Celia Cruz, PhD, reports that “materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.” As a result, the safety and effectiveness of the drug can be affected, leading the FDA to study the issues and monitor developments with nanotechnology.

Primarily, the FDA set out to determine if the “current regulatory processes are adequate to identify any potential risks and reduce those risks.” The FDA’s Center for Drug Evaluation and Research Nanotechnology Risk Assessment Working Group (Nano Group) was used to conduct an extensive review of the emerging technology.

The Nano Group concluded that the FDA’s current processes are adequate for monitoring nanomaterials. However, the team also identified areas for improvement, such as increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials.

Nanotechnology Benefits Mesothelioma Researchers

Mesothelioma is a rare, aggressive cancer primarily caused by exposure to airborne asbestos fibers. Designated as an orphan disease in the U.S., a disease that affects fewer than 200,000 people, mesothelioma treatment is limited to managing symptoms and extending survival. Currently, there is no cure available, and the average survival time is less than 18 months. However, researchers are now looking to nanotechnology as a way to attack mesothelioma.

  • The NYU Langone Medical Center’s Cancer Institute recently purchased a NanoString Technologies nCounter Analysis System with funds donated by the New York mesothelioma lawyers of Belluck & Fox, LLP. Dr. Pass, Chief of Thoracic Oncology, NYU Cancer Center and Chief, Division of Thoracic Surgery, NYU Langone Medical Center, is a renowned mesothelioma specialist and is a past winner of the Pioneer Award from the Mesothelioma Applied Research Foundation for his dedication to mesothelioma research. This tool allows Dr. Pass and his colleagues to obtain faster results as they seek the clues to better treatments and, one day, a cure for mesothelioma.
  • In 2011, the University of Pennsylvania established the Penn Center for Orphan Disease Research and Therapy focused on discovering novel treatments for rare diseases. One of the primary goals of the Center is to focus on nano-scale systems for developing new ways to deliver drugs.
  • Researchers at the Institute of Bioengineering and Nanotechnology in Singapore developed a miniaturized biochip using nanotechnology that can assess the effectiveness of anti-cancer drugs on cancer stem cells. This is especially important for allowing oncologists to offer personalized medicine to mesothelioma patients.

“Nanotechnology is a new and exciting field that offers scientists the opportunity to control matter at very small dimensions, opening many possibilities for making all kinds of new products,” said Ms. Cruz.

Sources:
FDAVoice
MIT News
University of Pennsylvania
US FDA Nanotechnology Fact Sheet

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