XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
  Cornea
  Cataract
  Retina
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Nov 17th, 2006 - 22:35:04

Ophthalmology Channel
subscribe to Ophthalmology newsletter

Latest Research : Ophthalmology

   DISCUSS   |   EMAIL   |   PRINT
Encapsulated Cell Technology Brings New Hope for Patients with Retinitis Pigmentosa
May 2, 2005, 10:28, Reviewed by: Dr.

"These safety and tolerability results are extremely encouraging and strengthen our confidence in pursuing NT-501 for treating RP and other retinal degenerative diseases. I would like to thank the National Eye Institute for conducting this milestone study and for its continued involvement with this technology."

 
Neurotech SA, a specialist in the development of novel therapies for retinal diseases, today announced positive results from an open-label Phase I clinical trial (03-EI-0234) of its lead product, NT-501.

NT-501 uses Neurotech's patented Encapsulated Cell Technology (ECT) as a device to deliver ciliary neurotrophic factor (CNTF) to eyes of visually impaired patients with retinitis pigmentosa (RP).

Results confirm that CNTF can be safely delivered into the vitreous of patients with RP and that the ECT device was well tolerated by all patients.

Futhermore, some patients experienced more than one-line of improvement in their visual acuity score. These Phase I results were presented at the ARVO annual meeting and the trial was conducted at the National Eye Institute (NEI), Bethesda, USA. Neurotech has confirmed that it will now progress to a multi-center Phase II trial.

ECT, a technique developed and patented by Neurotech, allows for genetically-engineered specific protein delivery without manipulating the patient's genetic information or transferring new genetic information into the target tissue.

The Phase I study of NT-501 involved 10 patients with late- stage RP. The study was designed as an open-label safety and tolerability evaluation. Two doses of CNTF (5-fold difference in dose) were evaluated. Phase Ia treated 5 patients with a lower dose; Phase Ib treated 5 patients with a higher dose. The ECT device was implanted in one eye per patient and removed after six months. All explanted devices contained viable cells that continued to produce CNTF.

Commenting on the positive results, Weng Tao, MD, PhD, CSO and VP of R&D with Neurotech said:

"These safety and tolerability results are extremely encouraging and strengthen our confidence in pursuing NT-501 for treating RP and other retinal degenerative diseases. I would like to thank the National Eye Institute for conducting this milestone study and for its continued involvement with this technology."

Al Reaves, PhD, VP of Clinical Development with Neurotech confirmed: "This study represents the first use of ECT in human eyes and it is reassuring that the devices were safe and well-tolerated. We are planning Phase II development with well-designed and controlled multi-center clinical studies to help understand the role that NT-501 will play in treating patients with retinitis pigmentosa and other retinal degenerative conditions."

In this trial, the small ECT device was surgically-implanted into the vitreous cavity through the pars plana in one eye per patient.

The primary inclusion criteria for the study eye included visual acuity of 20/100 or worse, central visual field diameter of 40 degrees or less, and flicker ERG amplitude of 2 microV or less. The first 2 patients were also required to have visual acuity of 20/400 or worse. After surgical implantation of the device, each patient was followed for six months after which the device was explanted. Safety and tolerability was monitored by an independent Data and Safety Monitoring Committee. All 10 patients completed the study as planned and the devices have been explanted.

The ECT devices were well tolerated during the 6 months of implantation and the surgical procedure resulted in minimal or no observed inflammatory reaction. No serious adverse events were reported and in the untreated fellow-eye, there was little change from baseline in the visual acuity score during follow-up.

In the treated study-eye, however, the visual acuity score was more variable during follow-up: while some treated eyes showed little change from baseline, some patients experienced more than one-line of improvement in their visual acuity score.

Bernard Davitian, President of Neurotech, said: "We are extremely pleased that the Phase I trial has validated the safe use of the Encapsulated Cell Technology to deliver CNTF to the vitreous. In addition, the Phase I trial has validated ECT as a delivery platform for the back of the eye and the visual acuity outcomes observed in some patients are encouraging enough to pursue the clinical evaluation of NT-501 in Phase II trials. In addition to further studies with NT-501, we are evaluating other neurotrophic factors and agents that can be used with ECT for treating other retinal diseases."

In addition to NT-501 for the treatment of Retinitis Pigmentosa, Neurotech is applying ECT technology to deliver other protein factors for the treatment of other ophthalmic diseases, including anti-angiogenic factors for the treatment of the wet form of age-related macular degeneration (AMD) and diabetic macular edema (DME), and anti-inflammatory factors for the treatment of posterior uveitis.

About Retinitis Pigmentosa (RP)

RP is a group of inherited retinal diseases that affects about 100,000 Americans and 1.5 million people worldwide. It causes the progressive deterioration of specialized, light-absorbing cells in the retina, the paper- thin tissue that lines the back of the eye like film in a camera. As these cells slowly degenerate, people with RP develop night blindness and a gradual loss of peripheral vision. By about age 40, most have tunnel vision, although many may retain good central vision. Between the ages of 50 and 80, however, they typically lose their remaining sight. The extent of vision loss in people of the same age with RP may be different.

About Encapsulated Cell Technology (ECT)

ECT is a unique technology to overcome drug delivery problems into the back of the eye. ECT enables the controlled, continuous, long-term delivery of therapeutic proteins directly to the retina. In addition, the implants can be retrieved, providing an added level of safety as well as the ability to reverse or adjust therapy, if needed. ECT relies on the use of an immunoisolatory hollow fiber membrane technology to allow the implantation of genetically engineered cells that continuously produce the therapeutic protein at the site of implantation. The cells are loaded into the interior volume of the hollow fiber membrane and attach to a proprietary supportive matrix within this space. The genetically modified cells remain captive within the ECT device thus avoiding the risks associated with traditional gene therapy. Long term protein delivery (18 months) in the vitreous cavity of the eye has consistently been achieved when ECT devices containing human retinal pigmented epithelial (RPE) cells genetically engineered to secrete CNTF have been implanted in a highly disparate mammalian species (rabbits).
 

- National Eye Institute
 

www.neurotechusa.com

 
Subscribe to Ophthalmology Newsletter
E-mail Address:

 

About Neurotech

Neurotech is a biotechnology company specializing in the development of novel therapeutics to treat diseases of the eye. The company's initial focus is on chronic diseases affecting the back of the eye, especially the retina, because retinal diseases represent the greatest unmet medical need and therefore offer the largest market opportunities in ophthalmology. The Company has one product (NT-501) in development for the treatment of retinitis pigmentosa and other degenerative diseases of the retina, and is evaluating other neurotrophic factors and agents that can be used with ECT for treating other retinal diseases. The company is headquartered in Paris with an American subsidiary, Neurotech USA, Inc., located in Lincoln, RI, south of Boston. Neurotech is supported in its scientific and business strategies by world experts in ophthalmology and by a group of international investors led by Apax Partners and Merlin Biosciences.

To learn more about Neurotech, please visit our web site at www.neurotechusa.com


Contacts: At Neurotech: (401) 333-3880 x3136, Bernard Davitian, President - [email protected], Mobile +33-(0)6-21-06-01-43; Al Reaves, VP of Clinical Development - [email protected], Mobile (678) 488-9629; Media relations - Northbank Communications: +44-20-7886-8150; Sue Charles, CEO - [email protected], Mobile: +44-(0)7968-726585; Fiona Brown, Consulant - [email protected], Mobile: +44-(0)7803-065765


Related Ophthalmology News

Master Proteins Dictate Retinal Differentiation Timetable
Yellow plant pigments lutein and zeaxanthin reduce risk of age-related macular degeneration
Objective way to diagnose diseases of colour perception
Onchocerciasis treatment reduces prevalence and intensity by 38%
Antioxidants may slow retinal degeneration
Hormone Therapy Does Not Affect Age-Related Vision Loss
Eating Fish Protects Against Macular Degeneration
Research Highlights Risk Factors For Age-Related Vision Loss
How Thalamic Neurons Grab Your Attention
FDA approves ranibizumab for the treatment of wet age-related macular degeneration


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us