Neurotech’s NT-501 has been identified by the FDA as potentially being able to meet the unmet medical need in treating retinitis pigmentosa (RP) and the dry form of age-related macular degeneration (dry AMD).
Both treatments use Neurotech’s Encapsulated Cell Technology (ECT) delivery system, which has been developed for administering therapeutics to the eye over long periods of time.
Ted Danse, president and CEO of Neurotech, said: “We remain on track to announce top line results from our two Phase II/III studies in RP and our Phase II study in dry AMD by early 2009.
“The receipt of Fast Track designations for NT-501 in these indications is an important component in our ongoing product development strategy, allowing us to potentially accelerate our two clinical development programs as we seek to provide much needed treatment options for patients facing these devastating diseases.”
Neurotech’s ECT delivery system consists of genetically modified human cells encapsulated within a semi-permeable hollow fiber membrane. The cells are modified to produce the desired therapeutic factor, which for NT-501 is ciliary neurotrophic factor (CNTF).
The semi-permeable nature of the membrane makes the body’s oxygen and nutrients available to the cells, allowing them to survive for up to 18 months. Cell survival is also promoted as the membrane prevents the immune system from attacking them.
While blocking molecular and cellular elements of the immune system, the membrane allows for the therapeutic to flow out of the device to reach the target regions. This delivery system bypasses the blood-retina barrier, providing a continuous delivery of therapeutics directly to the affected region.
Using the device anti-angiogenic, neurotrophic and anti-inflammatory factors could be delivered to the eye. These factors could be effective in the treatment of a range of ailments, including glaucoma, diabetic retinopathy and ocular inflammations.
Neurotech’s device is 6mm long with a suture loop at one end to attach it to the sclera. Implantation of the device takes 20 minutes and can be performed as an out-patient procedure.
As NT-501 has been fast-tracked by the FDA appropriate aspects of its development and review will be expedited. This can extend to the FDA accepting aspects of the marketing application for review prior to the final registration package being completed.