Global engineering technologies company,
The study's repeated delivery regime, which allows for a prolonged therapeutic window, is crucial to achieve the potential neuroprotective and neurorestorative actions of CDNF, and has been made possible through the use of
Initial results indicate predictable and accurate placement of the device as well as its positive performance and safety. The Company will continue to assess the results as the data is analysed and through the extension part of the study, as patients receive ongoing monthly infusions of CDNF using the
He added, 'These results allow us to build towards CE marking of
About the device
Thanks to this innovative, patented design, patients are able to receive infusions in an out-patient setting, rather than requiring the reimplantation of new catheters for each infusion, which has been the only option for many trials to date.
About the study
The study was a first-in-human, study whereby 17 patients were randomised to receive either one dose per month for six months, of a placebo, or six increasing doses of
The primary endpoints evaluate the safety, performance/tolerability of both the drug delivery system and CDNF as well as surgical accuracy. Secondary to this, the potential efficacy of the drug, rated against the Unified Parkinson's Disease Rating Scale (UPDRS) motor score evaluation, was also monitored.
The clinical study has received funding from the
About Parkinson's
Parkinson's is a neurodegenerative disease, caused by the break-down of dopamine producing neurons in the brain. Symptoms include involuntary shaking, stiffness of muscles and slowing down of movement, which can be extremely debilitating. In addition, patients can suffer associated non-motor symptoms such as difficulty sleeping, memory loss, anxiety and depression. Whilst these symptoms can initially be managed with medication, there is currently no treatment available that effectively prevents disease progression, or that treats the motor and non-motor symptoms together.
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