LINCOLN, R.I., Nov. 6 Neurotech Pharmaceuticals, Inc., abiotechnology company focused on the development of sight-saving therapeuticsfor chronic retinal diseases, announced today the completion of enrollment ofthree on-going clinical studies. Each study is evaluating NT-501, theCompany's lead product, for the treatment of visual loss associated withretinitis pigmentosa (RP) and the dry form of age-related macular degeneration(dry AMD). NT-501 is an intraocular, cell containing polymer implant designedto provide the continuous, long-term release of the therapeutic protein,Ciliary Neurotrophic Factor (CNTF), directly into the back of the eye by meansof the Company's proprietary Encapsulated Cell Technology (ECT).
"This is a very significant achievement for the Company and a criticalmilestone in the development of NT-501," said Ted Danse, President and CEO ofNeurotech. "We are very pleased with how quickly enrollment was completed forall three clinical studies and we anticipate announcing top line results forthese studies by the end of FY 2008."
"The Foundation Fighting Blindness has been a key partner in both thepreclinical and clinical studies of the NT-501," said Stephen Rose, Ph.D.,Chief Research Officer of the Foundation. "We are particularly excited aboutNeurotech's treatment, because it holds promise for saving the vision ofpeople affected by a range of retinal degenerative diseases."
RP is an inherited disease that causes the retina's rod and conephotoreceptors to gradually degenerate leading to loss of vision andblindness. The symptoms of RP predominately appear in young adults and affectapproximately 100,000 people in the United States and over 1 million peopleworldwide. At this time there is no known cure or effective treatment for RP.
AMD is a chronic progressive disease of the macula that results in theloss of central vision. It is the leading cause of blindness in elderlypeople in the developed world. There are two forms of AMD; dry and wet. DryAMD is the most common form of AMD representing approximately 90% of all AMDcases. In its later stages dry AMD involves the degeneration ofphotoreceptors and retinal pigment epithelial cells, a chronic conditioncalled geographic atrophy (GA). GA affects approximately 1 million people inthe United States for which there currently are no effective treatments.
Phase II/III Study - RP (early stage)
This randomized, multi-centered, double-masked, sham controlled study isevaluating NT-501 in 60 subjects with early stage RP. Each subject receiveseither a high or low dose NT-501 implant in one eye and a sham treatment inthe other eye. Visual field sensitivity is the primary efficacy endpoint ofthis study.
Phase II/III Study - RP (late stage)
This randomized, multi-centered, double-masked, sham controlled study isevaluating NT-501 in 60 subjects with late stage RP. Each subject receiveseither a high or low dose NT-501 implant in one eye and a sham treatment inthe other eye. Visual acuity is the primary efficacy endpoint of this study.
Phase II Study - dry AMD
This randomized, multi-centered, double-masked, sham controlled study isevaluating NT-501 in 48 subjects with dry AMD. Each subject receives either ahigh or low dose NT-501 implant or a sham treatment in one eye only. Visualacuity is the primary efficacy endpoint of this study.
Neurotech is a privately-held biotechnology company located in Lincoln,Rhode Island, specializing in the development of sight-saving therapeutics forchronic retinal diseases. Retinal diseases represent significant unmet medicalneeds for which new medical therapies are the largest market opportunity inophthalmology.
Neurotech's lead product (NT-501) is in two Phase II/III clinical trialsfor the treatment of visual loss associated with retinitis pigmentosa and