Lux Biosciences Initiates Clinical Trials of Its Second Pivotal Stage Program.LX201, A One-Year Cyclosporine cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe A Eluting Silicone Matrix Implant for Cornea cornea: see eye. Transplantation JERSEY CITY, N.J. -- 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 LUCIDA (LUx Corneal Transplant corneal transplant Ophthalmology The replacement of a damaged cornea with a cadaveric–healthy donor cornea; CTs are indicated in severe corneal injury or for corneal ulcers with residual scarring Implant Development and Advancement of Therapy) pivotal clinical trial program of LX201, the company's cyclosporine A (CsA) eluting silicone matrix implant. The LUCIDA pivotal program, which consists of two controlled studies, is investigating the use of LX201 in patients at elevated immune mediated risk of rejection or graft loss subsequent to cornea transplantation. Lux Biosciences expects to enroll a total of more than 400 patients across two pivotal protocols. The LUCIDA trials are being conducted at approximately 35 sites in North America, Europe and India. Efficacy is measured at one year, assessing signs of rejection reactions, such as increased corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). thickness or inflammation of the cornea, as well as graft loss. "The start of the LUCIDA pivotal program marks yet another important milestone for Lux Biosciences. The company has within two months moved two projects providing novel treatment modalities into pivotal phase: the CsA-eluting silicone matrix implant, LX201, for cornea transplantation and our next generation calcineurin inhibitor, LX211, for uveitis uveitis Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. . Both products target high medical need indications with a substantial economic potential. No approved treatment currently exists to prevent rejection in cornea transplantation, and steroids are the only drugs currently approved in uveitis," said Ulrich Grau, Ph.D., Lux Biosciences' president and chief executive officer. "This positions Lux Biosciences to potentially gain two product approvals in 2009." Further details regarding the protocols, LX201-01, LX201-02 are available on the website http://clinicaltrials.gov. About LX201 LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year. Cyclosporine A is used widely as systemic therapy systemic therapy Therapeutics Any therapy that reaches target tissues via the systemic circulation for the prevention of rejection following kidney and other solid organ transplantation The transfer of organs such as the kidneys, heart, or liver from one body to another. The transplantation of human organs has become a common medical procedure. Typical organs transplanted are the kidneys, heart, liver, pancreas, cornea, skin, bones, and lungs. , LX201 is implanted under the eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball. eye·lid or eye-lid n. into the subconjunctival space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an . Lux Biosciences plans to clinically evaluate the implant for the prevention of rejection in corneal transplantation Corneal Transplantation Definition In corneal transplant, also known as keratoplasty, a patient's damaged cornea is replaced by the cornea from the eye of a human cadaver. . LX201 has received Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status in both the United States and Europe. About Cornea Transplantation Approximately 35,000 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 Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. -- and thus is less prone to acute rejection, up to a third of all patients are at increased risk of immune-mediated rejection or graft loss. Current practice in the postoperative management of patients at increased risk for graft loss due to immunological causes varies. In the United States, corneal transplantation is usually an outpatient procedure and consequently, topical steroids are used commonly while the use of systemic corticosteroids and immunosuppressive agents is limited. In Europe, on the other hand, physicians use systemic immunosuppressive medications more frequently following corneal transplantation in patients at increased risk for rejection. In cases of severe graft rejection, intravenous corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. may be used. 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. Both the LUMINATE pivotal clinical program for Lux Biosciences' next generation calcineurin inhibitor, LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with the company's cyclosporine A episcleral implant, LX201 for the prevention of corneal transplant rejection have been 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. |
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