Phytopharm plc announces preliminary data indicating that Cogane has demonstrated efficacy in a genetic preclinical model of amyotrophic lateral sclerosis (ALS).
The study was performed in a model that has a mutation in the SOD1 gene (SOD1G93A); mutation of the SOD1 gene is a known cause of ALS in humans. In this study Cogane was administered orally for 50 days, commencing after ALS type symptoms were manifest. This is therefore considered to be a model of severe, late-stage ALS.
• Administration of Cogane resulted in a 30-50% improvement in muscle strength in one muscle type compared to both the untreated control group and a group treated with riluzole (currently the only product marketed for the treatment of ALS).
• Treatment with Cogane also resulted in an increase in the number of motor units (a measure of functional motor neurones) compared with both the untreated and riluzole treated control groups.
• Treatment effects were less clear in a second muscle type which was more severely damaged in the model, though the group treated with Cogane again showed an improvement in strength compared to the riluzole treated group.
These are preliminary, headline results and the full results from the study, including histopathology data, will be published in due course.
These results support those reported previously by Phytopharm in which Cogane showed benefit in an environmental (toxin-induced) model of ALS, in a progressive motor neuropathy model and in a nerve crush model. Collectively the results from these four different models of ALS provide strong support for the utility of Cogane in the treatment of this condition.
ALS, also known as Lou Gehrig’s disease, is the most common form of motor neurone disease, a neurodegenerative disease with limited treatment options and poor prognosis. It is characterised by progressive loss of both lower (spinal cord and brain stem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. There is an urgent need for the development of new approaches to this devastating condition.
Phytopharm has obtained orphan drug status in Europe and the US for Cogane in ALS.
This study was performed by the group of Professor Linda Greensmith, University College, London, with the financial support of the Motor Neurone Disease Association, a UK based charitable organisation.
Professor Greensmith commented, “The data from this genetic model of ALS are very encouraging and, taken with the data from the other models of ALS in which it has been tested, indicate that Cogane has significant potential as a therapy for ALS and merits further evaluation.”
Mr Tim Sharpington, CEO, Phytopharm, said, “These results are very encouraging as we set a difficult challenge in this study by looking for efficacy in a severe, end-stage disease model. We have established an impressive set of data for CoganeTM in a broad range of neurodegenerative disease models, including Parkinson’s and Alzheimer’s disease as well as ALS. There is a major unmet need and substantial commercial opportunity for new therapies which can delay or halt the progression of these diseases. We look forward to receiving more data on Cogane as we complete our ongoing clinical study in Parkinson’s disease.”
Date: January 16, 2012
Source: Phytopharm plc