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Phytopharm PLC (PYM.L) Announces Commencement of Phase II Study of Cogane(TM) in Patients with Parkinson's Disease

11/17/2010 2:18:25 PM

Huntingdon, Cambridgeshire, UK (17 November 2010) – Phytopharm plc (LSE: PYM) (“Phytopharm” or the “Company”) today announces commencement of recruitment of patients with early stage Parkinson’s disease into the Cogane™ Phase II proof-of-concept and dose ranging study.

The study will investigate the efficacy, safety and tolerability of Cogane™ administered for 28 weeks to approximately 400 patients with early stage Parkinson’s disease. Three doses of Cogane™, administered orally once daily, will be compared with placebo. The primary endpoint for the study will be the change from baseline to end of treatment in activities of daily living and motor function as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III. Secondary endpoints will include measures of non-motor symptoms, including cognitive function and also assessments of Quality of Life.

The study is being conducted in leading movement disorder centres in the US, UK, Canada, Germany and France. The Company anticipates that results from the study will be available by end of 2012.

Roger Hickling, Research & Development Director, said: “This is an important milestone for Phytopharm and is the culmination of many months of hard work by Phytopharm staff, their advisers and contract research organisations. Efforts will continue to ensure timely recruitment of patients into the study with the aim of delivering definitive results by the end of 2012.”

Dr. Warren Olanow, one of the Co-Chief Investigators for the study and a member of Phytopharm’s scientific advisory panel on Parkinson’s disease (PD) commented: “I am delighted that enrolment has now begun. I, and the PD research community, are hopeful, and eager to learn about the potential benefits that Cogane might have on the motor and non-motor symptoms of PD, and its effects on quality of life for patients with early-stage PD. Cogane is believed to be the first, orally active, small molecule inducer of neurotrophic factors to be tested in PD. It has the potential to enhance function of damaged nerve cells and protect other nerve cells from the neurodegenerative process. If successful, it will offer a new therapeutic alternative to patients who suffer from this debilitating disease”.

About Phytopharm

Phytopharm is focused on the development of its pharmaceutical programmes. The Company has focused its research and development activities in areas of high unmet health needs. 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 and leading scientists and clinicians help guide the company’s research and development activities.

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 preclinical models of Parkinson’s disease, Cogane™ elevates glial cell line-derived neurotrophic factor (GDNF) and brain derived neurotrophic growth factor (BDNF), reverses the loss of dopaminergic neurones, and significantly reduces Parkinsonian symptoms.

In a previously conducted non-clinical study, oral administration of Cogane™ over 18 weeks significantly reduced parkinsonian disability by 43% in non-humane primates.

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

Certain information included in these statements is forward-looking and involves risk and uncertainties that could cause results to differ materially from those expressed or implied by the forward looking statements.

Forward-looking statements include, without limitation, projections relating to results of operations and financial conditions, market estimates, the Company’s plans and objectives for future operations, including future revenues, financial plans and expected expenditures and divestments. All forward-looking statements in this report are based upon information known to the Company on the date of this announcement. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

It is not reasonably possible to itemise all of the many factors and specific events that could cause the Company’s forward looking statements to be incorrect or that could otherwise have a material adverse effect on the future operations or results of the Company.

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