Healthcare Industry News:  Glaucoma 

Biopharmaceuticals Ophthalmology FDA

 News Release - November 28, 2006

Lux Biosciences Receives FDA Clearance for LX211 IND

Pipeline Milestone Paves The Way For Pivotal Trials Of Next Generation Calcineurin Inhibitor In Uveitis

JERSEY CITY, N.J., Nov. 28 (HSMN NewsFeed) -- Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that the 30- day waiting period for its Investigational New Drug Application (IND) for the development of LX211 in uveitis has elapsed, paving the way for initiation of pivotal clinical trials in early 2007. The program consists of three controlled, double masked studies that will enroll a total of over 500 patients:

-- LX211-01 will investigate the use of LX211 as a steroid-sparing agent in the treatment of active posterior, intermediate and panuveitis;

-- LX211-02 will investigate the ability of LX211 to maintain control of inflammation in patients with quiescent posterior, intermediate and panuveitis;

-- LX211-03 will investigate the use of LX211 as a steroid-sparing agent in the treatment of patients with active anterior chamber inflammation.

Investigators in North America and Europe will participate in the clinical program. Details will be posted shortly on the website http://clinicaltrials.gov.

"We're very pleased that we've succeeded in moving this project along according to plan," said Ulrich Grau, president & CEO of Lux Biosciences. "With preparations well under way, we look forward to enrolling our first uveitis patient into the pivotal studies by early January of next year. We believe that our next generation calcineurin inhibitor LX211 has great potential; a well-studied and approved medication other than steroids would be enormously beneficial for patients who suffer from this debilitating disease."

About LX211

LX211 is a next generation calcineurin inhibitor to which Lux Biosciences has an exclusive world-wide 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 preventing rejection in transplant patients and in a range of autoimmune diseases, including non- infectious uveitis and also appears to be well-tolerated. Lux Biosciences plans to develop this molecule also in other ophthalmic indications, such as dry eye syndrome.

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 uveitis.

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 U.S. are caused by this disease. Approximately 300,000 people suffer from uveitis in the U.S. 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 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 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 LX201, a 1-year cyclosporine A eluting silicone matrix implant for the prophylaxis of rejection in cornea allograft recipients, and LX211, a next-generation calcineurin inhibitor that has potential in several ophthalmic diseases and, as such, represents a pipeline of product opportunities. The initial one of these is planned to enter pivotal clinical testing by early 2007, and -- if successful -- Lux expects it will reach the market in 2009

-- A proprietary product-enabling bio-erodable polymer technology that allows targeted delivery of molecules to the eye

This strategy is being implemented by an experienced, execution-oriented management team that combines a history of achievement in drug development and commercialization with deep insight and scientific expertise in immunology and ophthalmology. More information on Lux Biosciences can be found at www.luxbio.com.



Source: Lux Biosciences

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