Last checked at 14 Jun 2010 07:00
Phytopharm receives USA regulatory approval to begin Phase II clinical trial of Cogane™
Patient enrolment is planned to begin in late 2010
GODMANCHESTER, Cambridgeshire, UK, 14 June 2010 - Phytopharm plc (LSE: PYM) ("Phytopharm" or "the Company") today announces that the Company's investigational new drug (IND) application for its lead pharmaceutical candidate Cogane™ for the treatment of Parkinson's disease has been granted by the US Food and Drug Administration (FDA).
The FDA has agreed the protocol for the Phase II proof of concept trial with Phytopharm. The study will investigate the efficacy, safety and tolerability of CoganeTM administered for 28 weeks to patients with early stage Parkinson's disease. The primary endpoint for the study will be the change in activities of daily living and motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III. Other efficacy endpoints include assessment of cognitive function and quality of life. Safety assessments include standard ECG assessment, effects on blood pressure and pulse, and haematology and clinical chemistry monitoring. The study will be conducted in a number of countries, including the USA and the UK, and regulatory submissions in the other countries will be submitted shortly. Preparatory work is continuing with Contract Research Organisations (CROs) who will conduct the study on behalf of Phytopharm. The Company expects recruitment of patients into the study to commence in the next 6 months.
Sandy Morrison, Interim CEO, said: "This IND for Cogane™ is an important milestone for Phytopharm. It confirms the quality of our preclinical data and development plan. We look forward to the enrolment of patients in this Phase II trial, but recognise that it will be about 2 years before we have definitive results from the study. Nevertheless this is an important next step towards bringing a potentially disease-modifying new therapy for Parkinson's disease closer to market fruition."
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Notes to Editors
| Enquiries Phytopharm plc Sandy Morrison, CEO +441480 437 697 Roger Hickling, R & D Director +441480 437 697 |
| U.K. Investor Relations FD Ben Atwell John Dineen +44 20 7269 7193
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About Phytopharm
Phytopharm is focused on the development of its pharmaceutical programmes and has a residual portfolio of functional foods. The Company's products are developed predominantly from medicinal plants, thereby reducing the development risk of a product. The Company has focused its research and development activities on areas of high unmet health needs to deliver cures and relieve suffering for longer healthier lives. As a virtual company, the Company's business model is centered on a lean cash burn with all laboratory, manufacturing and clinical work outsourced to specialists, while core competencies such as strategy and management are maintained in-house. Close collaboration with charitable organisations enhances the Company's interaction with scientists and clinicians, who lead and develop expert opinion. Cash grants from them accelerate the Company's development programmes, thereby increasing their value.
About Cogane™
Phytopharm's lead development candidate is Cogane™ for the treatment of Parkinson's disease. Cogane™ is a novel small molecule, orally bioavailable neurotrophic factor inducer that readily crosses the blood brain barrier. In preclinical studies, Cogane™ stimulates the release of neurotrophic factors and increases neurite outgrowth. Importantly, Cogane™ also reverses the decrease of neurotrophic factors and reverses dopaminergic neuronal degeneration observed in vitro. When administered orally in several different preclinical models of Parkinson's disease, Cogane™ reverses the loss of dopaminergic neurones and elevates glial cell line-derived neurotrophic factor (GDNF).
About Parkinson's disease
Parkinson's disease is a movement disorder characterised by muscle rigidity, tremor, 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, which is responsible for the control of movement. This is caused by degeneration of dopaminergic neurones between the striatum and the substantia nigra part of the brain, 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. The prevalence of Parkinson's disease globally is expected to increase to approximately 9 million people by 2030 (Source: Neurology). In the US alone, there are estimated to be 1.5 million patients diagnosed with Parkinson's disease (Source: American Parkinson's Disease Association), with associated healthcare costs of $25 billion (Source: Northwest Parkinson's Foundation submission to US Congress). Parkinson's disease can affect people of any age, though the incidence is higher in older people. The cause of Parkinson's disease in the majority of cases is unknown. Possible mechanisms include oxidative damage of nerve cells coupled with loss of neurotrophic factors such as GDNF.
Phytopharm is listed on the Official List of the London Stock Exchange. Further information on Phytopharm is available from the Company's website www.phytopharm.com