A bit more information13 Feb 2013 18:44
During the period
· The last patient completed participation in the CONFIDENT-PD Phase II clinical trial of Cogane™ in untreated patients with early-stage Parkinson's disease in December 2012. Results from this trial remain on track to be available in February 2013.
· Further work is ongoing with a number of leading opinion leaders and charities with an interest in Cogane™ in Amyotrophic Lateral Sclerosis ("ALS") to design a clinical development plan. Provisional indications for financial and logistical support for future studies of Cogane™ as a treatment for ALS have been received.
· A meeting has been held with the US Food and Drug Administration ("FDA") at which a clinical development plan for Cogane™ in ALS was agreed. Cogane™ for ALS has been granted Orphan Drug status which offers the potential for accelerated development compared with conventional drug development programs.
· A Phase I study of new solid dose formulations of Cogane™ was initiated and results are expected in Q1 2013.
· Our financial performance from 1 October 2012 to date continues to be in line with our expectations. Based on our current expectations Phytopharm is financed until at least the end of Q1 2014.
Mr Tim Sharpington, CEO commented: "Whilst completing the CONFIDENT-PD clinical trial in Parkinson's disease the Company has been planning for the next stage of development. We have been pleased to receive the support of leading opinion leaders and charities for our development plans for Cogane™ in ALS, which we believe can add value alongside our work in Parkinson's disease. We have also had discussions with the FDA and potential pharmaceutical partners about how best to complete the development and commercialisation of Cogane™. The results from the CONFIDENT-PD clinical trial will be important in determining how our future strategy evolves and we look forward to receiving these results shortly".
Cogane™ in Parkinson's disease
Parkinson's disease is a movement disorder characterised by muscle rigidity, tremor and a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the result of altered signalling in an area of the brain, the striatum, responsible for the control of movement. This is caused by degeneration of dopaminergic neurones that project from the substantia nigra to the striatum, leading to insufficient formation and action of dopamine. Parkinson's disease is therefore termed a neurodegenerative disease. The disease is slow in onset and the appearance of symptoms reflects the gradual loss of dopaminergic neurones.
Progress to date
Cogane™ in Parkinson's disease - progress to date
The preclinical neuroprotective profile of Cogane™ suggests that it will have benefit on both motor and non-motor symptoms of Parkinson