Credit: Photo courtesy: Roger Barone / Wills Eye Hospital.
Wills Eye Hospital's Carol Shields, MD examines patient
(clinical study participant). Oncology research fellow, wearing protective
eyewear, also observes.
Newswise, April 3, 2017 – A first-of-its-kind, potentially
groundbreaking new option for treating a form of eye cancer is now in its first
phase-1 clinical research trial at Wills Eye Hospital in Philadelphia.
The treatment, called light-activated AU-011, developed by
Aura Biosciences of Cambridge, Massachusetts, is an investigational drug that
targets and aims to selectively destroy malignant cancer cells in patients who
have life-and vision-threatening eye cancer, also known as, ocular melanoma.
Ocular melanoma is a malignant cancer that develops within the
eye. It affects as many as 3,000 people per year in the United States. While
melanoma is often associated with skin cancer from sun exposure, ocular
melanoma does not relate to the sun, developing instead from abnormal pigmented
cells in the eye.
The danger with ocular melanoma is that there are often no
symptoms, making it difficult to detect resulting in the potential of quietly
spreading throughout other parts of the body.
Risk factors include being Caucasian, fair-skinned, and the
risk of developing the disease also increases as we age. The best way to detect
ocular melanoma is to have an annual comprehensive dilated eye exam by a board
certified ophthalmologist.
This innovative treatment approach now being investigated at
Wills Eye Hospital uses viral nanoparticle conjugates, which is a targeted
therapy of growing interest in medicine.
The treatment involves injecting the AU-011 investigational
drug into the eye affected by cancer followed by the brief use of a companion
ophthalmic laser treatment to activate the drug.
The investigational drug is expected to destroy the membranes
of the ocular melanoma while sparing key eye structures which may allow for the
potential of preserving patients’ vision.
“Patients with ocular melanoma currently have few treatment
options available that can effectively destroy tumor cells while preserving
vision. Conducting valuable research trials like this one enables clinicians
and researchers to examine new and better options for patients throughout the
world,” said, Carol L. Shields, MD, Co-Director of the Ocular Oncology Service
at Wills Eye Hospital where the first US patient was treated.
Dr. Shields is also a key investigator in the research trial
and the author of numerous top peer-reviewed publications on ocular melanoma,
including identification of the risk factors for early diagnosis (Kaliki &
Shields 2016 in Nature Eye.)
Currently, the primary treatment option for ocular melanoma is
plaque radiotherapy which was, in part, pioneered in the United States by the
Shields Oncology team at Wills Eye Hospital.
While that therapy has achieved high success throughout the
years in tumor control for patients, this new potential targeted therapy may
open the door to a less invasive method of treatment.
“We are delighted to be one of the pre-eminent clinical trial
sites in the nation for this unique and promising treatment. Wills Eye has
always been a leader in the clinical application of emerging new therapies. We
are 100% behind our world’s best oncology team,” said, Julia A. Haller, MD,
Ophthalmologist-in-Chief, Wills Eye Hospital.
The trial, which began in early 2017, is expected to enroll up
to 12 patients at Wills Eye and other clinical trial sites.
Trial investigators will focus on evaluating the safety of two
dose levels of AU-011 for the treatment of patients with small to medium
primary ocular melanoma. Potential participants must have a confirmed ocular
melanoma diagnosis not previously treated. Patients treated in the trial will
be observed and followed for 2 years.
About Carol L. Shields, MD: Dr.
Carol Shields is Co-Director of the Oncology Service, Wills Eye Hospital, and
Professor of Ophthalmology at Thomas Jefferson University in Philadelphia. She
has authored or co-authored 9 textbooks, over 1000 articles in major journals,
nearly 300 textbook chapters, given over 600 lectureships, and has received
numerous professional awards of major national and international standing
including The American Academy of Ophthalmology Life Achievement Honor Award.
Dr. Carol Shields is a member of numerous ocular oncology,
pathology and retina societies and has delivered 30 named lectureships in
America and abroad. She practices ocular oncology on a full time basis with her
husband, Dr. Jerry Shields on the Oncology Service at Wills Eye Hospital.
About Wills Eye Hospital: Wills
Eye Hospital is a global leader in ophthalmology, established in 1832 as the
nation’s first hospital specializing in eye care. U.S. News & World Report
consistently ranks Wills Eye as one of America’s top ophthalmology centers
since the survey began and has the most nationally ranked ophthalmologists in
the country.
Wills Eye is a premier training site for all levels of medical
education. Its resident and post-graduate training programs are among the most
competitive in the country. One of the core strengths of Wills is the close
connection between innovative research and advanced patient care. Wills
provides the full range of primary and subspecialty eye care for improving and
preserving sight, including cataract, cornea, retina, emergency care, glaucoma,
neuro-ophthalmology, ocular oncology, oculoplastics, pathology, pediatric
ophthalmology and ocular genetics, and refractive surgery.
Ocular Services include the Wills Laser Correction Center, Low
Vision Service, and Diagnostic Center. Its 24/7 Emergency Service is the only
one of its kind in the region. Wills Eye also has a network of nine
multi-specialty, ambulatory surgery centers throughout the tri-state area. To
learn more, please visit www.willseye.org
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