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JERSEY CITY, N.J. (June 25, 2008): Lux
Biosciences today announced the completion of enrollment for the landmark
LUMINATE (Luveniq Uveitis Multicenter Investigation
of a New Approach to TrEatment) pivotal clinical
trial program, which is investigating the use of LUVENIQ™ (voclosporin;
previously designated LX211) as a corticosteroid-sparing agent for the
treatment of patients with non-infectious uveitis. As planned, the three
randomized, placebo-controlled, double-masked studies together enrolled a
total of about 560 patients at 58 sites in 7 countries.
“We are very pleased to have completed patient enrollment in an expeditious
manner in this largest-ever clinical trial program in non-infectious uveitis,
and thank our clinical investigators and their staff for their enthusiasm
and diligence,“ said Ulrich Grau, Ph.D., Lux Biosciences’ President and
Chief Executive Officer. “As patients in the LUMINATE program are treated
and followed for six months, we expect to complete these studies prior to
year-end. If the studies are successful in demonstrating efficacy and
safety, we will seek regulatory approval for LUVENIQ in 2009.”
In the LUMINATE program LUVENIQ is being examined utilizing inflammation as
an endpoint in both the anterior (front) and posterior (back) segments of
the eye. If approved, LUVENIQ will be the first steroid-sparing agent to be
commercialized for uveitis in the United States and in most international
markets.
About LUVENIQ
LUVENIQ is the oral form of a next-generation calcineurin inhibitor,
voclosporin, to which Lux Biosciences has an exclusive worldwide license for
ophthalmic indications from Isotechnika, Inc., of Edmonton, Canada.
Isotechnika is currently investigating voclosporin in phase 3 clinical
trials in psoriasis patients, and has just recently completed a phase 2b
clinical trial in kidney transplant recipients. The clinical data gathered
to date indicate that this molecule is a potent calcineurin inhibitor (a
biological mechanism demonstrated to provide efficacy in prevention of organ
graft rejection and in a range of autoimmune diseases) with a wide
therapeutic window. In addition to its use in uveitis, Lux Biosciences is
developing this next generation calcineurin inhibitor in proprietary topical
formulations for other ophthalmic indications, including dry eye syndrome
and other chronic inflammatory ocular surface diseases, and in age-related
macular degeneration.
About Uveitis
Uveitis is an autoimmune disease characterized by chronic inflammation of
the eye. Uveitis is an under-diagnosed and under-recognized medical
condition that causes vision impairment, ocular pain, and loss of vision.
Experts estimate that 10% of new cases of blindness in the United States
result from this disease. Approximately 300,000 people suffer from uveitis
in the United States alone, the majority of whom are affected by anterior
uveitis; Lux Biosciences is targeting roughly a third of the disease
population for potential treatment. The only therapeutic class approved by
the FDA for treatment of uveitis is corticosteroids, which are burdened with
multiple side effects, such as osteoporosis, hyperglycemia,
hypercholesterolemia, hypertension, mood disturbances, and if applied
chronically to the eye, cataract formation and glaucoma.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused
on ophthalmic diseases. The company has a staged product portfolio of
potentially first-in-class therapies distinguished by their short-term
path to commercialization and potential to generate high revenue growth.
The portfolio includes:
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Two Phase 3 clinical-stage projects
including: i) LUVENIQ™, the oral formulation of a next-generation
calcineurin inhibitor (voclosporin) developed as steroid-sparing
therapy for the treatment of non-infectious uveitis, and ii) LX201,
a silicone matrix ocular (episcleral) implant that steadily releases
therapeutic doses of cyclosporine A locally to the eye for the
prevention of rejection in cornea transplant recipients. Both the
LUMINATE pivotal clinical program for LUVENIQ for the treatment of
uveitis, as well as the LUCIDA (Lux Corneal Transplant Implant
Development and Advancement of Therapy) pivotal clinical program
with LX201 for the prevention of corneal transplant rejection were
initiated in early 2007 and include sites in North America, Europe
and India.
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LX214, a novel topical eye drop
formulation currently in IND-enabling studies with a target date for
entry into the clinic in 2008. LX214 is based on Lux’ proprietary
next-generation calcineurin inhibitor and is targeted towards other
chronic inflammatory diseases of the eye, most notably dry eye
syndrome, blepharitis and atopic keratoconjunctivitis.
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Several earlier stage projects based on
proprietary product-enabling bio-erodible polymer technologies that
facilitate targeted and sustained delivery of molecules to the eye.
For more information on Lux Biosciences, please visit the company’s
website at www.luxbio.com.
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CONTACTS:
Lux Biosciences, Inc.
Ulrich Grau, Ph.D.
+1 201 946 0221
Ulrich.grau@luxbio.com
Kureczka/Martin Associates (media)
Joan Kureczka
+1 415-821-2413
Jkureczka@comcast.net
© 2008 Lux
Biosciences, Inc. All rights reserved.
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