BUSINESS WIRE
JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences today announced the completion of enrollment in the
company’s phase 3 LUCIDA (LUx Corneal Transplant Implant
Development and Advancement of Therapy) clinical trial
program for LUMITECT™ (LX201). LX201 is a silicone matrix ocular
(episcleral) implant designed to provide the continuous release for one
year of therapeutic levels of cyclosporine A locally to the eye to
prevent corneal transplant rejection.
“We are very gratified to have reached this important developmental
milestone for LUMITECT, a therapeutic product candidate that has the
potential to address a major medical need for which there are no
currently approved treatments,” said Ulrich Grau, Ph.D., President and
Chief Executive Officer of Lux Biosciences. “Moreover, we have
accomplished this goal, as well as the completion of our phase 3
LUMINATE program in uveitis for LUVENIQ™ and the start of Phase 1
testing for a third product, LX214, that was developed de novo for dry
eye, in less than three years from our company’s founding.”
Dr. Grau noted that Lux Biosciences expected data from the first of two
pivotal LUCIDA studies later in 2009, while data from the second study
would become available in the first half of 2010.
The LUCIDA clinical trial program is investigating the one-year use of
LX201 in patients at elevated immune-mediated risk of rejection or graft
loss subsequent to cornea transplantation. The program has recruited a
total of 493 patients in 3 protocols. The two masked, placebo-controlled
studies that are intended to support product registration are identical
protocols in distinct geographic regions in which high-risk cornea
transplant patients receive a LX201 implant at the time that penetrating
keratoplasty is performed.
One of the two protocols recruited patients at 30 sites in the United
States and Germany (N=190); this trial completed patient enrollment in
July 2008. The second, identical protocol began in March 2008 and
recruited patients at 9 sites in India (N=181), completing recruitment
in March 2009. A third protocol, in which patients received LX201
subsequent to having experienced a rejection episode, was discontinued
owing to slow recruitment; however this third study will provide
additional safety information. In each protocol, subjects are randomized
to receive implants containing two different dose levels of active drug
or placebo. The endpoint for all three protocols is the incidence of
rejection episodes or graft loss at 1 year for each dose group versus
placebo.
About LUMITECT (LX201)
LUMITECT is a silicone matrix ocular implant that steadily releases
therapeutic doses of cyclosporine A locally to the eye for one year. Two
different dose level implants are being studied, a 0.75 inch implant
that elutes approximately 20-25 µg/day of cyclosporine A, and a 0.5 inch
implant that elutes approximately 15 µg/day of cyclosporine A
(cyclosporine A is used widely as systemic therapy for the prevention of
rejection following kidney and other solid organ transplantation).
LUMITECT is implanted under the eyelid into the subconjunctival space
(the area beneath the transparent tissue covering the white of the eye)
in a minimally invasive procedure. Lux Biosciences is evaluating the
implant clinically for the prevention of rejection in corneal
transplantation. LUMITECT has received Orphan Drug status in both the
United States and Europe, and Fast Track status in the United States.
About Cornea Transplantation
Approximately 32,000 corneas are transplanted each year in the United
States and an additional 22,000 in Europe. While the cornea is generally
a tissue that is not vascularized — does not contain blood vessels — and
thus is less prone to acute rejection, the rate of rejection reactions
in high risk corneal transplant patients is in the range of 50 percent
over one year. This is comparable to the rate of rejection experienced
in kidney transplantation in the 1970’s, prior to the introduction of
modern immunosuppressive therapies.
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
sight-threatening non-infectious uveitis, and ii) LUMITECT™, a
silicone matrix ocular (episcleral) implant that steadily releases
therapeutic doses of cyclosporine A locally to the eye for the
prevention of rejection in corneal transplant recipients. Both the
LUMINATE pivotal clinical program for LUVENIQ for the treatment of
uveitis, as well as the LUCIDA pivotal clinical program with
LUMITECT™, 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.
Enrollment in the LUCIDA program was completed in March 2009.
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LX214 is a novel and proprietary topical eye drop formulation that
entered human clinical testing for dry eye syndrome in February 2009.
Based on Lux’s proprietary next-generation calcineurin inhibitor,
LX214 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 http://www.luxbio.com.