Lux Biosciences Initiates LUMINATE Pivotal Clinical Trials Of Its Next-Generation Calcineurin Inhibitor, LX211, In Uveitis

Lux Biosciences, Inc., a
privately held biotechnology company specialized in the field of ophthalmic
diseases, announced today that the company had begun treating patients in
its LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to
TreatmEnt) pivotal clinical trial program of LX211, the company's
next-generation calcineurin inhibitor. The pivotal trial program, which
consists of three controlled, double masked studies, is investigating the
use of LX211 in different forms of active uveitis and to maintain control
in patients with quiescent disease.


Lux Biosciences is conducting each of the three LUMINATE protocols in
parallel with a high degree of overlap among study sites, with
approximately 45 sites participating in the trials in North America, Europe
and India. The company expects to enroll a total of more than 500 patients.
Efficacy is measured at six months assessing the degree of inflammation,
utilizing standardized scales for evaluation of inflammation in the
anterior (front) and posterior (back) segments of the eye. Lux Biosciences
has partnered with PRA International, a leading global Clinical Research
Organization (CRO), to execute the trials.



"Each of these trials targets a different patient population, including
patients whose disease is active, and patients who are currently controlled
by steroids and/or steroid-sparing agents but where LX211 may provide
further advantages in terms of safety and efficacy," said Ulrich Grau,
Ph.D., Lux Biosciences' president and chief executive officer. "Our
development program for LX211 continues according to plan, and we hope to
complete enrollment in this trial program by early 2008 and, if successful,
seek regulatory approval for LX211 in late 2008."



Further details regarding each of the three protocols, LX211-01,
LX211-02, and LX211-03 are available on the website
clinicaltrials.



About LX211



LX211 is a next-generation calcineurin inhibitor to which Lux
Biosciences has an exclusive worldwide license for ophthalmic indications
from Isotechnika, Inc., of Edmonton, Canada (Isotechnika's code ISA247).
Isotechnika is currently investigating ISA247 in phase 3 clinical trials in
psoriasis patients, and in a phase 2b clinical trial in solid organ
transplant recipients. The clinical data gathered to date indicate that
LX211 is a potent calcineurin inhibitor -- a biological mechanism
demonstrated to provide efficacy in a range of autoimmune diseases such as
noninfectious uveitis -- and also appears to be well tolerated. In addition
to uveitis, Lux Biosciences plans to develop this molecule in other
ophthalmic indications, including dry eye syndrome and age-related macular
degeneration.



About Uveitis



Uveitis is an autoimmune disease characterized by chronic inflammation
of the eye. There is substantial evidence implicating T-lymphocytes, key
cells involved in inflammatory processes, in the development of the
disease. 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 U.S. cases of blindness 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. The
only therapeutic class approved by the FDA for treatment of uveitis is
corticosteroids, which are burdened with multiple side effects, such as
hypertension, hyperglycemia, hypercholesterolemia, and in the eye, cataract
formation and glaucoma.



About PRA International



PRA International is one of the world's leading global clinical
development organizations, with over 2,700 employees working from offices
in North America, Europe, South America, Africa, Australia, and Asia. PRA,
an ISO 9001:2000 registered company, delivers services to its clients
through a unique approach called Project Assurance(R) which represents the
company's commitment to reliable service delivery, program-level
therapeutic expertise, easy, global access to knowledge and involved senior
management. For more information on PRA International, please visit
prainternational.



About Lux Biosciences



Lux Biosciences is a privately held biotechnology company dedicated to
the identification, optimization, development and commercialization of
products for the treatment of ophthalmic diseases. The company's business
strategy is characterized by:


-- A focus on compounds already marketed or with clinical proof-of-concept
in non-ophthalmic indications that Lux Biosciences will develop as
unique, targeted therapies for corresponding ophthalmic diseases, with
potentially greater efficacy and safety than existing treatments.


-- A clinical-stage portfolio of projects including: i) a next-generation
calcineurin inhibitor that has potential in several ophthalmic diseases
and, as such, represents a pipeline of product opportunities; and ii) a
silicone matrix ocular implant that steadily releases therapeutic doses
of cyclosporine A locally to the eye. Pivotal clinical studies of Lux
Biosciences' calcineurin inhibitor, LX211 for the treatment of uveitis,
initiated in February 2007 and pivotal studies of the cyclosporine A
implant, LX201 for the prevention of corneal transplant rejection, are
expected to start around the end of Q1, 2007.


-- A proprietary product-enabling bio-erodible polymer technology that
allows targeted and sustained delivery of molecules to the eye.



For more information on Lux Biosciences, please visit the company's
website at Lux Biosciences, Inc.


Lux Biosciences, Inc.

luxbio

Buy Famvir Without Prescription