Neurotech SA 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). Neurotech is a biotechnology company specializing in the development of novel therapeutics to treat diseases of the eye. The company is headquartered in Paris.
Results of the latest clinical trial 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.”