Products
NT-501 Retinis Pigmentosa
Neurotech's lead product, NT-501, consists of encapsulated human cells
genetically modified to secrete ciliary neurotrophic factor (CNTF).
NT-501 is designed to continually deliver a low, safe and therapeutic
dose of CNTF, a well-established neurotrophic factor, into the back
of the eye. The Company believes that CNTF activates dying retinal
photoreceptors and protects them from degeneration.
Preclinical Studies
Proof of concept studies performed by Neurotech established the utility of encapsulated cell therapy for the eye by testing cell-based delivery of CNTF to the retina in several different in vivo models of retinal degeneration. These studies demonstrated that CNTF delivery via cell secretion provided significant protection without any complications.
In collaboration with Cornell University and the Foundation Fighting Blindness, the efficacy of encapsulated CNTF-secreting cells was tested in a mutant canine model (rcd1) for retinal degeneration. Prototype ECT devices were implanted in one eye of each affected dog. Contralateral eyes were not treated. As shown in the figure below, significant photoreceptor protection was achieved seven weeks after implantation of the devices, with no serious complications related to either the surgical procedure or CNTF. This study demonstrated that ECT-mediated delivery of CNTF was effective and safe in an animal model and that it had the potential to be adapted for the treatment of human ophthalmic disorders.
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Photoreceptor (PR) protection in rcd1 dog model of Retinitis Pigmentosa. The eye implanted with the NT-501 device had significantly more photoreceptor cells than the untreated control. (5-6 layers vs. 2-3 layers)
Clinical Studies
A Phase I clinical study of NT-501 for the treatment of retinal
degeneration associated with RP was completed in early 2006. The
primary objective of the study was to investigate the safety of
NT-501 implants designed to secrete two dosage levels of CNTF over
a six month period of implantation in 10 late stage RP patients.
Results confirmed that CNTF can be safely delivered into the vitreous
cavity of the eyes of patients with RP and that the ECT device was
well tolerated by all patients. Visual acuity showed improved but
variable trends from baseline in the treatment group while in the
control arm visual acuity was essentially unchanged.
The Company completed enrollment for two Phase II/III clinical
studies for early and late stage RP, and one Phase II clinical study
for geographic atrophy associated with atrophic AMD at the end of
2007. More information about these trials can be found at www.RenoirRetinalStudies.com.
A copy of the ARVO poster containing Phase I data is accessible below
Arvo Poster [PDF]
Arvo Poster [Larger PDF]
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