The first, an oral presentation being given on May 5 during a satellite session of the American Uveitis Society by Quan Dong Nguyen, M.D. of the Wilmer Eye Institute, Johns Hopkins University and Hospitals, discusses the design of the ongoing LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to TrEatment) Phase 2/3 Clinical Trial Program. The three LUMINATE trials represent the first clinical development program aimed at supporting regulatory approval of a corticosteroid-sparing immunosuppressive agent in different types of sight-threatening, non-infectious uveitis.
The second, a poster presentation by Matthew A. Cunningham, senior medical student, senior author Robert Nussenblatt, MD, and collaborators from the National Eye Institute, Lux Biosciences, and Isotechnika, Inc., discusses preclinical data demonstrating the ability of subcutaneous injections of LX211 to prevent and reverse experimental autoimmune uveoretinitis (EAU) in rats. Cunningham commented, "We observed that in this animal model, LX211 could both prevent the onset of disease as well as reverse EAU at doses as low as 10 mg/kg. These preclinical results clearly support our view that LX211 may play an important future role in the treatment of uveitis."
The poster describes the induction of EAU in rats, which were then divided into three groups, designated preventative, therapeutic, and vehicle-control. Animals in the first two groups received daily subcutaneous injections of either cyclosporine A (CsA) at 40 mg/kg or LX211 at 2.5 mg/kg, 10 mg/kg or 40 mg/kg, with the preventative group beginning injections at day 0 and the therapeutic group beginning injections at day 7 after EAU induction. Six days after EAU induction, researchers began to evaluate the animals daily for clinical scores.
The vehicle-control and LX211 2.5 mg/kg therapeutic groups displayed the earliest clinical manifestations of EAU and highest clinical scores. None of the CsA or LX211 treated rats in the preventative group developed severe clinical disease. Histopathology confirmed that animals treated with LX211 at 40mg/kg were free of disease, in both therapeutic and preventative groups. These results were similar to results seen in the CsA group. LX211 therapeutic groups, 2.5 and 10 mg/kg, showed decreased histopathological EAU scores compared to controls. In rats treated with either LX211 or CsA, antigen-specific and non-specific responses of lymphocytes to the protein used to induce EAU were diminished compared to those of the control group.
"These positive preclinical results, combined with encouraging safety data from human clinical trials in other indications conducted by our partner Isotechnika, provide a strong rationale for our ongoing registration-directed LUMINATE studies of LX211 in uveitis," said Ulrich Grau, Ph.D., Lux Biosciences' president and chief executive officer. "We hope to complete enrollment in the LUMINATE trial program by early 2008 and, if successful, seek regulatory approval for LX211 in late 2008."
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 calcin eurin 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.
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 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) LX211, a next-generation calcineurin inhibitor that has potential in several ophthalmic diseases and, as such, represents a pipeline of product opportunities; and ii) LX201, a s ilicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye. Both the LUMINATE pivotal clinical program for LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007.
-- A proprietary product-enabling bio-erodible polymer technology that facilitates 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.