Press Releases
January 5, 2006
Neurotech Initiates a Phase II Clinical Trial of NT-501 for the
Treatment of Dry Age Related Macular Degeneration
Lincoln, RI and Paris, France, January 5, 2006
– Neurotech, a biotechnology company specializing in the development
of sight-saving innovative therapeutics for chronic retinal diseases,
announced today the initiation of a Phase II clinical trial of NT-501,
The Company’s lead Encapsulated Cell Technology (ECT) product
for the treatment of visual loss associated with the dry form of
age related macular degeneration (dry AMD).
NT-501 is an intraocular, polymer implant containing human retinal
epithelial cells genetically modified to secrete Ciliary Neurotrophic
Factor (CNTF). The implant is designed to continuously release CNTF
directly in the eye to the diseased retinal tissue for sustained
periods of time. The Phase II trial is a randomized, double-masked,
sham- controlled dose ranging study that will evaluate the efficacy
and safety of the CNTF implant and will be conducted at the National
Eye Institute (NEI) in Bethesda, Maryland.
“Dry AMD is a form of retinal disease that needs serious
attention and we are very pleased to begin the Phase II trial for
the indication,’ stated Ted Danse, CEO of Neurotech. “We
believe the improvement in visual acuity observed in our Phase I
trial will translate into a similar benefit for patients with advanced
stage dry AMD.”
An open-label Phase I clinical trial of NT-501 was conducted in
patients with retinitis pigmentosa (RP) by Paul A. Sieving, M.D.,
Ph.D., at the National Eye Institute. Dr. Sieving presented the
results last November at the American Academy of Ophthalmology,
and the results confirmed that CNTF can be safely delivered into
the vitreous of patients with RP. The ECT implants were well tolerated
by the RP patients, and some patients experienced improvement in
their visual acuity score.
According to Dr. Sieving, “the results from the Phase I trial
have encouraged us to study NT-501 in patients with atrophic macular
degeneration affecting their central vision, a type of degeneration
that is similar to that seen in the late stage RP patients enrolled
in the Phase I study”. Two Phase II studies of NT-501 in patients
with RP are also being planned for initiation in 2006 in conjunction
with the NEI.
About Neurotech
Neurotech is a privately-held biotechnology company dedicated to
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
clinical development for the treatment of retinal degeneration,
including retinitis pigmentosa, an inherited disease leading to
blindness, and 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,
to treat additional retinal diseases. The company’s U.S. office
is headquartered in Lincoln, RI, and European operations are located
in Paris. Neurotech is supported by leading world experts in ophthalmology
and by a group of international investors led by Apax Partners and
Merlin Biosciences.
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