Patient enrolment completed for prevention of corneal transplant rejection trial

Lux Biosciences has just completed its enrolment in the company's Phase III LUCIDA (LUx Corneal Transplant Implant Development and Advancement of Therapy) clinical trial programme for LUMITECT (LX201), a silicone matrix ocular (episcleral) implant designed to provide the continuous release for one year of therapeutic levels of cyclosporine A locally to the eye to prevent corneal transplant rejection.

"We are very gratified to have reached this important developmental milestone for LUMITECT, a therapeutic product candidate that has the potential to address a major medical need for which there are no currently approved treatments," said Ulrich Grau, Ph.D., president and chief executive officer of Lux Biosciences.

The LUCIDA clinical trial programme is investigating the one-year use of LX201 in patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. The programme has recruited a total of 493 patients in three protocols. The two masked, placebo-controlled studies that are intended to support product registration are identical protocols in distinct geographic regions in which high-risk cornea transplant patients receive an LX201 implant at the time that penetrating keratoplasty is performed.

One protocol recruited patients at 30 sites in the United States and Germany (N=190); this trial completed patient enrolment in July 2008. The second, identical protocol began in March 2008 and recruited patients at nine sites in India (N=181), completing recruitment in March 2009. A third protocol, in which patients received LX201 subsequent to having experienced a rejection episode, was discontinued owing to slow recruitment; however this third study will provide additional safety information. In each protocol, subjects are randomized to receive implants containing two different dose levels of active drug or placebo. The endpoint for all three protocols is the incidence of rejection episodes or graft loss at one year for each dose group versus placebo.

Lux Biosciences expects data from the first of two pivotal LUCIDA studies later in 2009, while data from the second study should become available in the first half of 2010.