CRANBURY, N.J., May 14, 2021 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin peptide receptor system,
today announced that it will host a key opinion leader (KOL)
webinar on melanocortin agonists for treating ocular indications,
with a primary focus on PL9643, the Company's lead asset. A Phase 3
clinical study of PL9643 in patients with dry eye disease (DED) is
planned for the second half of calendar year 2021. The
webinar will take place on Friday, May 21,
2021 at 10:00 am Eastern
Time.
The webinar introduces the Company's growing portfolio of
melanocortin agonists to treat the harmful effects of inflammation
in the eye. The event will feature presentations by KOLs Andrew W.
Taylor, Ph.D., Boston University;
Eric Donnenfeld, MD, Ophthalmic
Consultants of Long Island; George
Ousler, Ora Clinical; and Peter K.
Kaiser, MD, Cleveland Clinic. Dr. Taylor will discuss the
biology of the melanocortin system in the eye, Dr. Donnenfeld will
discuss the dry eye treatment landscape and unmet medical need, as
well as PL9643 Phase 2 Study data. Mr. Ousler will discuss the
PL9643 Phase 3 program and study design. Dr. Kaiser will finish
with retinopathy pre-clinical data and positioning.
In addition, John Dodd, Ph.D.,
Palatin's Sr. VP Research, will discuss Palatin's developing
portfolio of melanocortin agonists.
Carl Spana, Ph.D., President and
CEO of Palatin, will moderate the webinar and give a brief
corporate update.
A live question and answer session will follow the formal
presentations.
To register for the webinar, please click here.
About the Key Opinion Leaders
Andrew Taylor is associate dean of research and
professor of ophthalmology at Boston
University School of Medicine. A large part of his research
effort has been to characterize the immunosuppressive and
immunoregulating factors within immune privilege tissues. Through
immunochemical and biological analysis of aqueous humor, the fluid
filling the anterior chamber of the eye, he and his group have
identified several potent immunoregulating and immunosuppressing
neuropeptides that 1) suppress the activation of effector Th1
cells, 2) suppress the activation and the inflammatory activity of
macrophages, and 3) mediate the induction of antigen-specific
regulatory T cells.
His research has found constitutively present neuropeptides in
the immune privileged eye, including alpha-melanocyte stimulating
hormone (a-MSH), vasoactive intestinal peptide, calcitonin gene
related peptide, and somatostatin. Collectively, the neuropeptides
in aqueous humor suppress activation of delayed type
hypersensitivity of adaptive immunity, and endotoxin activation of
macrophages in innate immunity. Individually, the neuropeptides
target different cells and stages in the induction of an immune
response. Also, his laboratory has data suggesting a role for the
ocular neuropeptides in the regulation of macrophage functionality
in the immune privileged eye.
Professor Taylor is finding that within the ocular
microenvironment the activation of macrophages to pathogens does
not promote inflammation but promotes suppressor functionality in
the macrophages. These macrophages respond to pathogens without
mediating inflammation or activating T cells. Moreover, the
macrophages produce anti-inflammatory cytokines, suppress and
possibly induce apoptosis in activated T cells, and produce enzymes
associated with wound repair. Preliminary evidence suggests that
this is mediated by neurotransmitters of the sympathetic nervous
system, norepinephrine, and neuropeptide Y along with a-MSH and
somatostatin.
As Senior Vice President of Anterior Segment at Ora,
George Ousler oversees all dry eye
clinical programs, lending his therapeutic knowledge and expertise
to see each development project through to completion. He develops
clinical models and regulatory pathways for the evaluation of dry
eye therapies and has studied many of the agents under
investigation. The Dry Eye Department includes nearly 60 team
members who work with global clients in the U.S., Europe, and Asia, including Japan, China,
and South Korea.
George has more than 20 years of pioneering pharmaceutical
development around dry eye. He has authored more than 250
publications on the topic and has been invited to present his
research at numerous national and international symposia. He also
holds several patents on techniques, formulations, and methods
around dry eye and related conditions.
During his time at Ora, George has been pivotal in the
development and success of U.S. Food and Drug
Administration-approved products to treat dry eye, including
Xiidra® and TrueTear™ Intranasal Tear Neurostimulator. He often is
called on to consult on worldwide drug development and
registration, and frequently interacts with several regulatory
agencies, including the U.S. FDA, the European Medicines Agency,
the China Food and Drug Administration and the Pharmaceuticals and
Medical Device Agency (Japan).
Earlier positions in Ora's Dry Eye Department include Director,
Senior Clinical Manager, Clinical Manager and Clinical Research
Associate.
George serves on several noted dry eye research committees and
Scientific Advisory Boards. He is a member of several ophthalmic
professional organizations, including the Association for Research
in Vision and Ophthalmology, the Sjögren's Society and the Tear
Film & Ocular Surface Society and is a reviewer for numerous
scientific journals.
Peter K. Kaiser, M.D., is a Staff
member of the vitreoretinal faculty of the Cole Eye Institute in
the Department of Ophthalmology at Cleveland Clinic's main campus.
He was appointed in 1997. Dr. Kaiser is the Founding Director of
the Digital Optical Coherence Tomography (OCT) Reading Center at
the Cole Eye Institute.
Dr. Kaiser received his medical degree magna cum laude from
Harvard Medical School in Boston, Mass. He completed an internship in
internal medicine at Massachusetts
General Hospital, an ophthalmology residency at the Massachusetts
Eye and Ear Infirmary in Boston
and a retinal fellowship at Bascom Palmer Eye Institute in
Miami, Florida.
Actively involved in retinal clinical research, Dr. Kaiser is
study chairman of 4 major, multi-center, international clinical
trials and is a principal investigator in multiple other trials. He
serves on numerous scientific advisory boards and addresses his
research interests as an invited speaker at national and
international conferences. Dr. Kaiser is a major contributor to
medical literature having authored several ophthalmology texts, and
more than 200 book chapters, original reports, electronic
publications, and abstracts. He is an associate editor of the
American Journal of Ophthalmology, and serves on the editorial
boards of Retina, Retina Today, Retinal Physician and Ocular
Surgery News.
Dr. Kaiser has been recognized by the American Academy of
Ophthalmology and American Society of Retina Specialists with
Achievement and Senior Achievement Awards and is listed in the
"Best Doctors in America" list.
Eric Donnenfeld, M.D. is a
trustee of Dartmouth Medical School and a clinical professor of
ophthalmology at NYU. He was a resident
and Chief Resident at Manhattan Eye, Ear and Throat Hospital and
completed a Cornea Fellowship at Wills Eye Hospital in 1985.
Dr. Donnenfeld is the Editor-in-Chief of EyeWorld. He has
written over 200 peer review papers on cornea, external disease,
cataract, and refractive surgery, and 40 book chapters and books.
He is on the editorial board of 9 journals and has participated in
over 60 FDA studies.
Dr. Donnenfeld is a National Medical Director of TLC laser
centers and Surgical Director of the Lions Eye Bank for Long
Island. He served as president of Nassau Surgical Society, cornea
section of ASCRS, the International Ocular Microbiology and
Immunology Group, the Ophthalmology Division of the Nassau Academy
of Medicine, and many other professional societies.
About Melanocortins and Inflammation
The melanocortin
receptor ("MCr") system is hormone driven, with effects on food
intake, metabolism, sexual function, inflammation, and immune
system responses. There are five melanocortin receptors, MC1r
through MC5r. Modulation of these receptors, through use of
receptor-specific agonists, which activate receptor function, or
receptor-specific antagonists, which block receptor function, can
have significant pharmacological effects.
Many tissues and immune cells located in the eye express
melanocortin receptors, empowering our opportunity to directly
activate natural pathways to resolve disease inflammation.
About Dry Eye Disease (DED)
Dry eye disease is a
common inflammatory disease that, left untreated, can become
extremely painful and lead to permanent damage to the cornea and
vision. Dry eye disease affects the cornea and conjunctiva of the
eye resulting in irritation, redness, pain, and blurred vision. It
is estimated to affect over 20 million people in the United States. The disease is
characterized by insufficient moisture and lubrication in the
anterior surface of the eye, leading to dryness, inflammation,
pain, discomfort, irritation, diminished quality of life, and in
severe cases, permanent vision impairment. Existing therapy for dry
eye disease is generally regarded as inadequate by many physicians
and patients, and often requires weeks or months to demonstrate
activity.
About Palatin
Palatin is a biopharmaceutical company
developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin and natriuretic peptide
receptor systems, with targeted, receptor-specific product
candidates for the treatment of diseases with significant unmet
medical need and commercial potential. Palatin's strategy is to
develop products and then form marketing collaborations with
industry leaders to maximize their commercial potential. For
additional information regarding Palatin, please visit Palatin's
website at www.palatin.com
Forward-looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin, such as statements about market
potential of Vyleesi and other Palatin products in development,
clinical trial results, potential actions by regulatory agencies
including the FDA, regulatory plans, development programs, proposed
indications for product candidates, market potential for product
candidates, and potential adverse impacts due to the global
COVID-19 pandemic such as delays in regulatory review,
manufacturing and supply chain interruptions, adverse effects on
healthcare systems and disruption of the global economy, are
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. Palatin intends that such
forward-looking statements be subject to the
safe harbors created thereby. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
that could cause Palatin's actual results to be materially
different from its historical results or from any results expressed
or implied by such forward-looking statements. Palatin's actual
results may differ materially from those discussed in the
forward-looking statements for reasons including, but not limited
to, Palatin's ability to establish and maintain the capability for
manufacturing, marketing and distribution of Vyleesi, sales of
Vyleesi in the United States and
elsewhere in the world, results of clinical trials, regulatory
actions by the FDA and other regulatory and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully complete clinical trials, the length
of time and cost required to complete clinical trials and submit
applications for regulatory approvals, products developed by
competing pharmaceutical, biopharmaceutical and biotechnology
companies, commercial acceptance of Palatin's products, and other
factors discussed in Palatin's periodic filings with the Securities
and Exchange Commission. Palatin is not responsible for updating
for events that occur after the date of this press release.
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SOURCE Palatin Technologies, Inc.