BERKELEY, Calif., Aug. 22, 2012 (GLOBE NEWSWIRE) -- XOMA Corporation
(Nasdaq:XOMA), a leader in the discovery and development of therapeutic
antibodies, announced today that gevokizumab, the company's IL-1 beta
modulating antibody, has been granted Orphan Drug Designation by the
U.S. Food & Drug Administration (FDA) for the treatment of
non-infectious intermediate, posterior, or pan-uveitis, or chronic
non-infectious anterior uveitis.
The FDA Office of Orphan Products Development (OOPD) mission is to
advance the evaluation and development of products (drugs, biologics,
devices, or medical foods) that demonstrate promise for the diagnosis
and/or treatment of rare diseases or conditions. In fulfilling that
task, OOPD evaluates scientific and clinical data submissions from
sponsors to identify and designate products as promising for rare
disease and to further advance scientific development of such promising
medical products. The office also works on rare disease issues with the
medical and research communities, professional organizations, academia,
governmental agencies, industry, and rare disease patient groups.
About Gevokizumab
Gevokizumab (XOMA 052) is a potent monoclonal antibody with unique
allosteric modulating properties and the potential to treat patients
with a wide variety of inflammatory diseases and other diseases.
Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a
pro-inflammatory cytokine that has been shown to be involved in
Behcet's and other forms of non-infectious uveitis, cardiovascular
disease, and other auto-inflammatory diseases. In binding to IL-1 beta,
gevokizumab inhibits the activation of the IL-1 receptor, thereby
modulating the cellular signaling events that produce inflammation.
Servier is XOMA's development and commercialization partner for
gevokizumab. XOMA holds rights to gevokizumab in the U.S. and Japan for
non-cardiometabolic indications, including non-infectious uveitis,
acne, and erosive osteoarthritis of the hand for which clinical studies
are ongoing. Information on all gevokizumab clinical studies can be
found at www.clinicaltrials.gov.
About Non-infectious Uveitis
The term uveitis broadly refers to the inflammatory diseases that
affect the portion of the eye known as the uvea, which is the middle of
three layers that surround the eye. People with uveitis may experience
decreased vision, pain, light sensitivity, and floaters. Uveitis may be
caused by an infection that is commonly treated with an antimicrobial
agent, or by an unknown pathogen triggering inflammation, called
non-infectious uveitis.
The most common form of uveitis affects the front of the uvea and is
known as anterior uveitis. Other forms include intermediate uveitis,
posterior uveitis, and pan uveitis. These types differ in that they all
include involvement of the back portions of the uvea. Posterior uveitis
refers to inflammation in the retina and the choroid, and it may result
from a different immune response trigger. Pan-uveitis refers to
inflammation of all three major parts of the eye. Behcet's uveitis is a
well-known form of pan-uveitis. Due to the swelling of tissues critical
to vision, intermediate, posterior, and pan-uveitis (which collectively
make up NIU) can lead to blindness if not treated.
About XOMA Corporation
XOMA combines a portfolio of innovative therapeutic antibodies, both in
late-stage clinical development and in preclinical research, with its
recently launched commercial operations. XOMA focuses its antibody
research and development on allosteric modulation, which offers
opportunities for new classes of therapeutic antibodies to treat a wide
range of human diseases. XOMA is developing its lead product
gevokizumab (IL-1 beta modulating antibody) with Les Laboratoires
Servier (Servier) through a global Phase 3 program in non-infectious
uveitis and ongoing proof-of-concept studies in other IL-1-mediated
diseases. XOMA's scientific research also produced the XMet program,
which consists of three classes of preclinical antibodies, including
Selective Insulin Receptor Modulators (SIRMs) that could have a major
effect on the treatment of diabetes. In order to retain significant
value from its scientific discoveries, XOMA initiated commercial
operations in January 2012 through the licensing of U.S. commercial
rights to Servier's ACEON(R) (perindopril erbumine) and a
patent-protected portfolio of product candidates.
More detailed information can be found at www.xoma.com.
The XOMA Corporation logo is available at
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CONTACT: XOMA Corporation
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Canale Communications
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com