JERSEY CITY, N.J., Feb. 20 /PRNewswire/ -- 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 http://clinicaltrials.gov.
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 http://www.prainternational.com.
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 http://www.luxbio.com.
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
Lux Biosciences, Inc.CONTACT: Ulrich Grau, Ph.D. of Lux Biosciences, Inc., +1-201-946-0221,Ulrich.grau@luxbio.com; or Joan Kureczka of Kureczka/Martin Associates,+1-415-821-2413, Jkureczka@comcast.net, for Lux Biosciences, Inc.
