AGTC Announces Age-Related Macular Degeneration Scientific Advisory Board
June 01 2022 - 8:00AM
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
clinical stage biotechnology company focused on the development of
adeno-associated virus (AAV)-based gene therapies for the treatment
of rare and debilitating diseases with an initial focus on
inherited retinal diseases, today announced the formation of a
scientific advisory board (SAB) comprised of leading experts in
age-related macular degeneration (AMD). The SAB will provide
guidance on AGTC’s development of Complement Factor H (CFH),
intended for the treatment of dry AMD, and the company’s plans to
advance it through preclinical testing and into clinical
development.
The inaugural members of the SAB are:
David S. Boyer, MD |
Adjunct Clinical Professor, Keck School of Medicine, University of
Southern CaliforniaSenior Partner, Retina-Vitreous Associates
Medical Group, Los Angeles, CA |
David M. Brown, MD,
FACS |
Clinical Professor of
Ophthalmology, Baylor College of Medicine, Houston TXDirector of
Clinical Research, Retina Consultants of Houston, Houston, TX |
Jeffrey S. Heier,
MD |
Director, Vitreo-Retinal Service,
Ophthalmic Consultants of Boston, Boston, MA |
Nancy M. Holekamp,
MD |
Director, Retinal Services,
Pepose Vision InstituteSaint Louis, MO |
Peter K. Kaiser,
MD |
Professor of Ophthalmology,
Chaney Family Endowed Chair of Ophthalmology Research, Cleveland
Clinic College of MedicineCole Eye Institute, Cleveland, OH |
Arshad M. Khanani, MD,
MA |
Vitreo-Retinal Diseases and
SurgeryManaging Partner, Director of Clinical Research, Director of
Fellowship - Sierra Eye AssociatesClinical Associate Professor -
University of Nevada, Reno, Reno, NV |
David R. Lally, MD,
FASRS |
Director, Retina Research
InstituteNew England Retina Consultants, Springfield, MA |
Charles C. Wykoff, MD,
PhD |
Retina Consultants of TexasRetina
Consultants of AmericaBlanton Eye Institute, Houston Methodist
Hospital,Houston, TX |
“We are thrilled to have assembled such a fantastic Scientific
Advisory Board to help us plan for the clinical development of our
CFH program targeting dry AMD,” said Sue Washer, President and CEO
of AGTC. “These individuals have made significant contributions to
the ophthalmology community, and together will bring a wealth of
knowledge and guidance to us as we advance the program toward
clinical development. We look forward to their contributions in
support of our effort to develop a treatment for dry AMD.”
Jeff Heier, a newly appointed member of the SAB, added, “I feel
privileged to be a part of this distinguished group of clinicians
during this exciting time at AGTC. I look forward to engaging with
my colleagues and leveraging our collective experience to help the
Company advance its gene therapy program for the treatment of dry
AMD.”
About Dry Age-Related Macular Degeneration
AMD is a progressive retinal disease affecting millions of older
adults, and the leading cause of irreversible blindness in the
western world. Symptoms, which include blurry vision, loss of night
vision and loss of central vision, make activities of daily living
such as reading, driving and even recognizing faces progressively
more difficult. Third-party reports indicate there are
approximately 16 million patients with AMD in the United States
alone. Dry AMD, which results from an interaction of environmental
and genetic risk factors, represents about 90% of that population
(or about 15 million) in the US compared to about 1.4 million with
wet AMD. The genetic risk of developing dry AMD is significant,
with approximately 70% attributable risk of advanced disease to
heritability, while aging and smoking confer the strongest
non-genetic risk. CFH risk variants occur in approximately 40% of
patients with dry AMD and these patients have a significantly
increased risk of developing the disease as well as progression
from intermediate AMD to geographic atrophy. The complement system,
of which CFH is a regulator, is dysregulated in patients with these
risk variants, and results in amplification of aberrant
inflammatory responses in the eye. Over time, this dysregulation
leads to damage to the macular region of the retina.
About AGTC
AGTC is a clinical-stage biotechnology company developing
genetic therapies for people with rare and debilitating ophthalmic,
otologic and central nervous system (CNS) diseases. AGTC is a
leader in designing and constructing all critical gene therapy
elements and bringing them together to develop customized therapies
with the potential to address unmet patient needs. AGTC’s most
advanced clinical programs leverage its best-in-class technology
platform to potentially improve vision for patients with inherited
retinal diseases. AGTC has active clinical trials in X-linked
retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3). Its
preclinical programs build on the company’s industry leading AAV
manufacturing technology and scientific expertise. AGTC is
advancing multiple important pipeline candidates to address
substantial unmet clinical needs in optogenetics, otology and CNS
disorders, and has entered strategic collaborations with companies
including Bionic Sight, an innovator in the emerging field of
optogenetics, and retinal coding and Otonomy, Inc., a
biopharmaceutical company dedicated to the development of
innovative therapeutics for neurotology. For more information,
please visit https://agtc.com/.
Forward-Looking Statements This release
contains forward-looking statements that reflect AGTC's plans,
estimates, assumptions and beliefs, including statements about the
potential of the company’s gene therapy platform and its plans for
the pre-clinical and clinical development of CFH as a potential
treatment for dry AMD. Forward-looking statements include all
statements that are not historical facts and can be identified by
terms such as "anticipates," "believes," "could," "seeks,"
"estimates," "expects," "intends," "may," "plans," "potential,"
"predicts," "projects," "should," "will," "would" or similar
expressions and the negatives of those terms. Actual results could
differ materially from those discussed in the forward-looking
statements, due to a number of important factors. Risks
and uncertainties that may cause actual results to differ
materially include, among others: gene therapy is still novel with
only a few approved treatments so far; AGTC cannot predict when or
if it will obtain regulatory approval to commercialize a product
candidate or receive reasonable reimbursement; uncertainty inherent
in pre-clinical development, clinical trials and the regulatory
review process; risks and uncertainties associated with drug
development and commercialization; risks and uncertainties related
to funding sources for the Company’s development programs; the
direct and indirect impacts of the ongoing COVID-19 pandemic on the
Company’s business, results of operations, and financial condition;
factors that could cause actual results to differ materially from
those described in the forward-looking statements are set forth
under the heading "Risk Factors" in the company’s most recent
annual report on Form 10-K, as it may be supplemented by subsequent
periodic reports filed with the SEC. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Also, forward-looking statements
represent management's plans, estimates, assumptions and beliefs
only as of the date of this release. Except as required by law, we
assume no obligation to update these forward-looking statements
publicly or to update the reasons actual results could differ
materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future.
PR Contact:
Kerry Sinclair
Spectrum Science Communications
ksinclair@spectrumscience.com
Corporate Contact:
Jonathan Lieber
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5778
jlieber@agtc.com
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