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JERSEY CITY, N.J. (July 31, 2008):
Lux Biosciences today announced the
presentation of preclinical data demonstrating the safety and
pharmacokinetics of LX214 as a potential once-daily topical treatment
for chronic inflammatory diseases of the eye.
LX214 is a clear, micellar, topical formulation of voclosporin,
a next-generation calcineurin inhibitor licensed by Lux Biosciences from
Isotechnika, Inc. (Edmonton, AB, Canada), which Lux Biosciences is
developing as a potential treatment for such conditions as dry eye
syndrome, blepharitis, and atopic keratoconjunctivitis.
Lux Biosciences researchers and
collaborators presented the data in a poster session at the ARVO Summer
Eye Research Conference, “Ocular Immunity and Inflammation” held from
July 31 – August 2 at the Portola Plaza Hotel in Monterey, CA.
Highlights of the data included:
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Concentrations of LX214 (and/or residue)
establish therapeutic levels in tear fluid and most ocular tissues,
including conjunctiva, cornea, eyelids, sclera and lacrimal gland
after single or multiple topical applications of the experimental
drug. Blood levels of LX214 remained at or near base line, and there
was minimal distribution of LX214 to the opposite, non-treated eye.
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Tissue concentrations of LX214 in the
target tissues for ocular immune-mediated diseases were
significantly higher than the tissue concentrations of cyclosporine
A achieved by twice daily topical application of Restasis®
(cyclosporine 0.05%). These results are particularly important given
that voclosporin has been shown to be four-fold more potent than
cyclosporine A.
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No evidence of clinical irritation was
observed in any of the animals treated with LX214.
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No evidence of melanin binding by LX214
was observed.
“These data strongly support the further development of
LX214 as a topical product for serious ocular inflammatory conditions as
well as for dry eye syndrome,” said Ulrich Grau, Ph.D., President and
Chief Executive Officer of Lux Biosciences. “We believe that the product
has best-in-class potential based on the preclinical findings.”
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. Enrollment in the
LUMINATE program was completed in June 2008.
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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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