Science & Enterprise subscription

Follow us on Twitter

  • An international group of universities and companies is designing a next-generation device to restore more natural…
    about 15 hours ago
  • New post on Science and Enterprise: NIH Funds Natural Hearing Restoration Technology #Science #Business
    about 15 hours ago
  • The commissioner of the Food and Drug Administration warned that the sharp rise in teen electronic cigarette use i…
    about 18 hours ago
  • New post on Science and Enterprise: FDA Chief Calls Teen Vaping an “Epidemic” #Science #Business
    about 18 hours ago
  • New contributed post on Science and Enterprise: Technology is Shaping the Future of Business Travel
    about 2 days ago

Please share Science & Enterprise

Follow by Email
Visit Us

Orphan Status Granted Eye Cancer Treatment

Woman's eyes

(Public Domain Pictures, Pixabay)

21 May 2015. Food and Drug Administration designated an experimental treatment for uveal melanoma, a rare and aggressive form of cancer in the eye, as an orphan drug that qualifies for incentives to expedite its development. Aura Biosciences also revealed results of preclinical tests showing the ability of its lead biologic therapy code-named AU-011 to treat eye tumors in lab animals.

Uveal melanoma, also called intraocular melanoma, is a disease where cancer cells form in the middle layer of tissue in the wall of the eye known as the uvea. Like the more well-known and prevalent melanoma skin cancer, older and fair-skinned people are more likely to develop uveal melanoma. While the disease occurs infrequently, it is still the most common form of eye cancer among adults, according to National Cancer Institute. Current treatment options for uveal melanoma are radiation therapy, which runs risks of damaging the eye, or surgery to remove the eye.

Aura Biosciences is a biotechnology company in Cambridge, Massachusetts that licenses research conducted at the lab of John Schiller at National Cancer Institute, part of National Institutes of Health. Schiller and colleagues study the ability of virus-like particles that prevent or treat cancers such as cervical cancer caused by human papillomavirus.

Aura Biosciences adapts Schiller’s concept to design synthetic viral protein shells about 55 nanometers in diameter. These shells then become the mechanism for transporting therapeutic molecules, in this case that bind to the uveal melanoma tumor cells. AU-011, says the company, is designed to deliver cancer cell-killing molecules to the tumors, while leaving normal eye tissue untouched. The protein shells with molecules are injected into they eye, then activated by standard ophthalmologic lasers, such as those used in outpatient clinics.

Aura Biosciences reported findings of preclinical tests of AU-011 at McGill University in Montreal with lab rabbits that had uveal melanoma grafted on their eyes, presented last week at a meeting of the Association for Research in Vision and Ophthalmology. The team found after three AU-011 treatments, from 80 to 100 percent of the tumor cells in the animals were killed, without damaging other tissue in their retinas.

Orphan drug designation is granted by FDA for diseases affecting fewer than 200,000 people in the U.S. Drugs and biologics with orphan status qualify for tax credits covering their clinical trials, as well as exemption from normal prescription drug user fees.

Read more:

*     *     *

Please share Science & Enterprise ...

Comments are closed.