Lux Biosciences Initiates Clinical Trials of Its Second Pivotal Stage Program
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 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. 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.
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 for the prevention of rejection following kidney and other solid organ transplantation, LX201 is implanted under the eyelid into the subconjunctival space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure. Lux Biosciences plans to clinically evaluate the implant for the prevention of rejection in corneal transplantation. LX201 has received Orphan Drug 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 -- 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 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.
Posted: April 2007