LINCOLN, R.I., Nov. 6 /PRNewswire/ -- Neurotech Pharmaceuticals, Inc., a biotechnology company focused on the development of sight-saving therapeutics for chronic retinal diseases, announced today the completion of enrollment of three on-going clinical studies. Each study is evaluating NT-501, the Company's lead product, for the treatment of visual loss associated with retinitis pigmentosa (RP) and the dry form of age-related macular degeneration (dry AMD). NT-501 is an intraocular, cell containing polymer implant designed to provide the continuous, long-term release of the therapeutic protein, Ciliary Neurotrophic Factor (CNTF), directly into the back of the eye by means of the Company's proprietary Encapsulated Cell Technology (ECT).
"This is a very significant achievement for the Company and a critical milestone in the development of NT-501," said Ted Danse, President and CEO of Neurotech. "We are very pleased with how quickly enrollment was completed for all three clinical studies and we anticipate announcing top line results for these studies by the end of FY 2008."
"The Foundation Fighting Blindness has been a key partner in both the preclinical and clinical studies of the NT-501," said Stephen Rose, Ph.D., Chief Research Officer of the Foundation. "We are particularly excited about Neurotech's treatment, because it holds promise for saving the vision of people affected by a range of retinal degenerative diseases."
RP is an inherited disease that causes the retina's rod and cone photoreceptors to gradually degenerate leading to loss of vision and blindness. The symptoms of RP predominately appear in young adults and affect approximately 100,000 people in the United States and over 1 million people worldwide. 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 the loss of central vision. It is the leading cause of blindness in elderly people in the developed world. There are two forms of AMD; dry and wet. Dry AMD is the most common form of AMD representing approximately 90% of all AMD cases. In its later stages dry AMD involves the degeneration of photoreceptors and retinal pigment epithelial cells, a chronic condition called geographic atrophy (GA). GA affects approximately 1 million people in the 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 is evaluating NT-501 in 60 subjects with early stage RP. Each subject receives either a high or low dose NT-501 implant in one eye and a sham treatment in the other eye. Visual field sensitivity is the primary efficacy endpoint of this study.
Phase II/III Study - RP (late stage)
This randomized, multi-centered, double-masked, sham controlled study is evaluating NT-501 in 60 subjects with late stage RP. Each subject receives either a high or low dose NT-501 implant in one eye and a sham treatment in the 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 is evaluating NT-501 in 48 subjects with dry AMD. Each subject receives either a high or low dose NT-501 implant or a sham treatment in one eye only. Visual acuity is the primary efficacy endpoint of this study.
About Neurotech
Neurotech is a privately-held biotechnology company located in Lincoln, Rhode Island, specializing in the development of sight-saving therapeutics for chronic retinal diseases. Retinal diseases represent significant unmet medical needs for which new medical therapies are the largest market opportunity in ophthalmology.
Neurotech's lead product (NT-501) is in two Phase II/III clinical trials for the treatment of visual loss associated with retinitis pigmentosa and a Phase II trial for the treatment of the dry form of age-related macular degeneration. Neurotech is also evaluating other factors that can be used with its proprietary delivery technology, Encapsulated Cell Technology (ECT), to treat additional retinal diseases.
To learn more about Neurotech and the clinical studies of NT-501, please visit our web site at www.neurotechusa.com.
CONTACT: Rich Small, Vice President, CFO of Neurotech Pharmaceuticals,
Inc., +1-401-305-3505, r.small@neurotechusa.com
Web site: http://www.neurotechusa.com/
