Ixico Regulatory News (IXI)

18 April 2012

Phytopharm plc

Recruitment into CONFIDENT‑PD Phase II study in Patients with Parkinson's disease complete

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today announces that recruitment into the proof of concept Phase II study in patients with Parkinson's disease (CONFIDENT‑PD) is complete. The study will complete in early December this year, following a 28-week treatment and 4-week follow-up period. Headline results from the study are expected in February 2013.

The study is investigating the efficacy, safety and tolerability of Cogane™ administered to over 400 patients with early stage Parkinson's disease. Three doses of Cogane™, administered orally once daily, are being compared with placebo. The primary endpoint for the study is 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 include measures of non-motor symptoms, including cognitive function. The study is being conducted in leading movement disorder centres in North America and Europe.

Mr Tim Sharpington, CEO, Phytopharm, said, "Completion of recruitment into this clinical study in patients with Parkinson's disease is an important milestone for Phytopharm. We look forward to receiving the results from the study early next year."

About Phytopharm

Phytopharm is a development stage pharmaceutical company developing novel treatments targeting diseases with high levels of unmet need. Our lead series of compounds, the sapogenins (including Cogane™ and Myogane™), has the potential to be a new class of therapy for neurodegenerative diseases including Parkinson's disease, ALS and glaucoma.

Phytopharm operates as a virtual company ensuring the majority of our financial resources are focused on our pharmaceutical pipeline. We utilise a network of scientific and clinical experts to help guide our development projects with our experienced pharmaceutical managers overseeing operations.

Our commercially focused development projects have the potential to produce significant treatment advances in our target areas of neurodegeneration and inflammatory disease. Our products are single chemical entities with novel mechanisms of action protected by strong patent families.

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

About Cogane™

Phytopharm's lead development candidate is Cogane™, a member of the sapogenin class of compounds. It is an orally bioavailable neurotrophic factor modulator that readily crosses the blood‑brain barrier. Cogane™ has demonstrated neuroprotective effects in a range of preclinical models of neurodegenerative diseases. Specifically, CoganeTM has been shown to induce and modulate the production of neurotrophic factors. The neuroprotective and neurotrophic actions of Cogane™ suggest potential beneficial effects in a range of neurodegenerative diseases, including ALS and Parkinson's disease.

Cogane™ has completed long term toxicology studies, has been formulated as a once daily, orally administered therapy and has completed Phase I studies demonstrating a good bioavailability and safety profile.

In addition to the Phase II trial of early stage Parkinson's disease (CONFIDENT‑PD), Cogane™ is being studied in preclinical models of amyotrophic lateral sclerosis (ALS).

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, responsible for the control of movement. This is caused by degeneration of dopaminergic neurones between the substantia nigra and the striatum parts 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 estimated at being 0.3% of the whole population in industrialised countries, rising to 1% in those over 60 years of age and to 4% of the population over 80. The market size for Parkinson's disease was $3.2 billion in 2009 and is forecast to grow to $4.6 billion in 2012.

Forward-looking statements

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.