Press Releases
October 8, 2003
Neurotech Announces Initiation of a Phase I Clinical Trial to
Evaluate the Safety of Ciliary Neurotrophic Factor Implant in the
Eye
Lincoln and Paris, October 8, 2003 - Specialized in the development
of innovative technologies for the treatment of retinal diseases,
Neurotech S.A., a biotechnology company headquartered in Paris and
its American subsidiary, Neurotech USA, Inc., announced today the
initiation of a Phase I clinical trial of NT-501, its lead Encapsulated
Cell Technology (ECT) product for the treatment of Retinitis Pigmentosa
(RP). The NT-501 device 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 trial will evaluate the safety
of the CNTF implant and will be conducted at the National Eye Institute
in Bethesda, Maryland.
Because intraocular delivery of CNTF has not been tested in patients
before, this initial trial will test the drug and the ECT device
in 10 pre-selected patients with late-stage RP. If this trial confirms
safety, a Phase II trial will then test the ability of the treatment
to preserve vision in earlier stage RP patients.
"This study represents an important and historic advancement
regarding the clinical evaluation of a novel drug therapy for Retinitis
Pigmentosa", said Bernard Chauvin, Chairman of the Board.
RP is an inherited degenerative eye disease with no effective treatment
options. Usually, the disease is diagnosed in young adults who experience
a loss of peripheral vision and night blindness. In time, those
afflicted with RP typically face a slow and irreversible loss of
sight following diagnosis. There are approximately 1 million people
worldwide with the disease. CNTF, a natural neuroprotective protein,
has been shown in a variety of animal models to protect against
the loss of photoreceptors. However, delivery of therapeutic proteins
into the eye is complicated by a number of issues. First, the blood-retina
barrier prevents oral or intravenous administration. Secondly, repeated
injections of CNTF directly into the eye on a weekly or monthly
basis represent an impractical therapeutic option.
The NT-501 implant facilitates delivery of the therapeutic molecule
directly to the target site within the eye in a sustained manner,
thereby circumventing the aforementioned delivery problems. Pre-clinical
studies have demonstrated that the NT-501 implant effectively protected
photoreceptors in the retina from degeneration, and it consistently
delivered CNTF into the eye for a year. The neuroprotective effect
was dose-dependent with greater protection observed with higher
doses. In addition, the implanted capsules were well tolerated and
retained function during the implant period.
"The initiation of this phase I study is an important milestone
in the development of Neurotech's lead ophthalmic ECT product for
retinal degeneration," said Bernard Davitian, Neurotech's CEO.
"The National Eye Institute's study represents an opportunity
to establish the safety of a novel therapeutic protein delivery
platform that may be applied in disease intervention for RP and
other degenerative diseases of the retina. We are grateful for the
support from the National Eye Institute and the Foundation Fighting
Blindness in helping us to get this trial underway."
Retinal diseases such as age-related macular degeneration and diabetic
retinopathy represent a major unmet medical need in ophthalmology
and affect millions of patients throughout the world. To treat these
diseases, Neurotech is developing ECT products to deliver a variety
of therapeutic factors, including a novel and potent anti-angiogenic
factor in a controlled, continuous manner into the eye. These products
are designed to overcome the drug delivery issues associated with
the blood-retina barrier while circumventing the problems associated
with repeated ocular injections.
Neurotech is supported in its scientific and business strategies
by world experts in ophthalmology and by a group of international
investors. Among the investors, Apax Partners, Merlin Biosciences,
GIMV and CDC-Innovation have representatives on the company's Board
of Directors.
For further information please contact :
Ted Danse, CEO
Neurotech
Phone: 1 401 333-3880 x3116
Email: t.danse@neurotechusa.com
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