Renishaw completes the main part of a multi-centre clinical trial
MPN editor Laura Hughes caught up with Rupert Jones, managing director of Renishaw Medical about the recent study.
The facts
- 17 patients enrolled in a phase 1-2 clinical study in combination with Herantis Pharma.
- Study was looking at Cerebral Dopamine Neurotrophic Factor (CDNF) as a treatment for Parkinson's disease.
- Allocation for patients was double-blind and randomized.
- Initially each patient received either one dose per month of a placebo or six increasing doses of CDNF for six months.
- Safety, performance/tolerability of both the drug delivery system and CDNF, surgical accuracy and efficacy of the drug against the UPDRS motor score evaluation was monitored.
LH: What is unique about Renishaw’s drug delivery system?
RJ: Renishaw’s drug delivery system is intended for long-term implantation, allowing the patient to receive repeated reaccess infusions, in an out-patient clinic, without the need for additional surgery. There are no other long-term implantable devices like this on the market at present so we feel that when the Renishaw drug delivery device obtains approval, it will meet an unmet clinical need.
LH: Following these results, what’s next?
RJ: Now that the first stage of the trial is over, all patients will receive CDNF in a six-month extension study, allowing for additional data collection for the drug and device.
LH: Anything else you’d like to add?
RJ: This is a product we have worked on for many years, taking a multidisciplinary approach to ensure we cover all bases and developing a unique solution to drug delivery to the brain. The ultimate measure of such a device is safety but we also have spent much time on usability and surgical technique, taking feedback from a range of surgeons during its design. However, this trial has also provided us with additional feedback that we hope will allow us to make the usability of our system better by providing an improved user-experience for surgeons, in addition to improving its safety and performance.