Ixico Regulatory News (IXI)

14 Oct 2009 07:00



14 October 2009

Phytopharm Announces Positive Headline Results in Parkinson's disease studies

GODMANCHESTER, Cambridgeshire, U.K. (14 October 2009) - Phytopharm plc (LSE: PYM) ("Phytopharm" or the "Company") today announces headline results from the successful completion of two key studies:

Efficacy study - Oral administration of Cogane™ over 18 weeks significantly reduced parkinsonian disability by 43% in a non-human primates - a macaque model of PD (the gold standard for PD research), which will be clinically highly relevant if repeated in PD patients. Encouragingly, a statistically significant reduction in parkinsonian symptoms was reached after 9 weeks of administration with Cogane™. The magnitude of the effect increased over the subsequent 9 weeks of administration and was still increasing at the end of the study in week 18. These data strongly support the continued development of Cogane™ as an exciting, new and potentially disease-modifying therapy for PD. This study was funded by a $1.16 million grant from the Michael J. Fox Foundation for Parkinson's Research (MJFF).

Phase Ib safety, tolerability and pharmacokinetic clinical study - Cogane™ was shown to be safe and generally well tolerated in both healthy volunteers and PD patients over the 28 day study period. Importantly, at steady state, plasma levels in PD patients taking Cogane™ at a dose of 150 mg/day reached levels associated with efficacy in the non-human primate study and other non-clinical disease models of PD.

The Company will present more detailed results at the forthcoming XVIII WFN World Congress on PD and Related Disorders in Miami (13 - 16 December 2009).

The positive results from these two studies strongly support the company's position that Cogane™ is a highly encouraging novel potential treatment for PD. These results justify Phytopharm's stated strategy to move forward rapidly to a Phase II, proof-of-concept study for Cogane™ in patients with PD. The study is planned to commence in Q2, 2010.

Katie Hood, Chief Executive Officer of MJFF, commenting on the non-clinical results said: "Ongoing development of therapies based around neurotrophic factors is critical in moving these proteins from promise to reality as a practical treatment for PD patients. MJFF remains optimistic about the continued development of an orally bioavailable product such as Cogane™ that might stimulate production of neurotrophic factors in the brain."

Tom Isaacs, Co-Founder of the Cure Parkinson's Trust (CPT) who has Parkinson's commenting on the results said: "We are delighted by the news from both these trials and especially that Cogane™ has been well tolerated by the first cohort of people living with PD who have tried this product. It is now important that the results from both these key studies are used, together with the recommendations of the scientific advisory panel, convened specifically for Cogane™, by CPT and Phytopharm to drive the development forward into a proof-of-concept clinical trial with some urgency. 

At last for people living with the condition here is an innovative, prospective treatment for Parkinson's which shows real promise. The Cure Parkinson's Trust will do all it can to ensure the full potential of this treatment is realised." 

Dr. Jonathan Brotchie, Senior Scientist, Toronto Western Hospital, commented: "These results demonstrate that Cogane™ can reverse parkinsonian disability in MPTP-lesioned macaques, the gold standard model for assessment of novel strategies for PD. This is the first treatment I have seen with proven potential to reverse the disease process in macaques and not just treat PD symptoms. Cogane™ holds the promise to be the first of a new class of treatments for PD patients."

Sandy Morrison, CEO commented: "We are delighted with the positive results from the two studies.  Real progress has been made in 2009. We intend to move rapidly to a proof-of-concept clinical study which will represent a key milestone in the development of Cogane™. We would like to acknowledge the strong support from both the PD charities for the Cogane™ programme which made these results possible".

About the efficacy study in Non-clinical Model of Parkinson's disease

In a Phytopharm study conducted by Dr Jonathan Brotchie, a senior scientist at the Toronto Western Hospital and University Health Network (Toronto), Cogane™ or vehicle alone was administered orally to macaques (n=7 per group) with stable parkinsonism. Assessments of parkinsonian disability were made at baseline and following 18 weeks of treatment. Parkinsonian disability was evaluated regularly by a neurologist blinded to the treatment allocation. In this study, administration of Cogane™ for 18 weeks significantly reduced the median overall parkinsonian disability score by 43% (pp No statistically significant changes in parkinsonian disability were observed with vehicle alone. Dr Brotchie is a recognised expert in the field of Parkinson's disease and runs one of the world's premier research laboratories for the identification of novel treatments, diagnostics and cures for Parkinson's disease and related disorders.

This work builds upon earlier Phytopharm positive results in mice and provides a valuable link to the human condition since macaques share behavioural and neuroanatomical similarities to humans that are not present in mouse models of Parkinson's disease.

About the Phase Ib, Safety, Tolerability and Pharmacokinetic Clinical Study

In this study, conducted under a clinical trial authorisation from the UK Medicines and Healthcare Products Regulatory Agency, subjects were randomised consecutively, to one of three cohorts (n=9/cohort), to receive either Cogane™ or placebo in a 2:1 ratio, for 28 days. In cohorts A and B healthy volunteers received Cogane™ at a dose of 150 mg/day or 450 mg/day, respectively, or placebo. In cohort C, patients with mild-moderate PD received Cogane™ 150 mg/day or placebo. All investigational products were taken orally. A review of safety and pharmacokinetic data was held prior to continuing with the subsequent cohort. There were no serious adverse events in the study. No subjects discontinued due to adverse events that were considered likely to be directly related to Cogane™. The pharmacokinetics of Cogane™ at the 150 mg/day dose level in PD patients was not appreciably different than in healthy subjects and by Day 28 (steady state) the plasma concentration profiles of Cogane™ were virtually superimposable. In healthy subjects, exposure to Cogane™ increased approximately proportionally in relation to dose.

About Cogane™

Cogane™ belongs to a family of sapogenins, protected by an extensive Phytopharm patent portfolio, that are orally bioavailable and are able to cross the blood-brain barrier. Once in the central nervous system they induce the production of neurotrophic factors. By inducing the production of endogenous neurotrophic factors, Cogane™ overcomes the technical problems associated with the delivery of neurotrophic factors, due to their protein nature, in PD patients.

About Parkinson's disease

Parkinson's disease is a degenerative disorder of the central nervous system characterised by muscle rigidity, tremor and a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement. The primary symptoms are the result of altered signalling in the striatum, an area of the brain responsible for the control of movement. This is caused by degeneration of dopaminergic neurones between the striatal and the substantia nigral regions of the brain leading to insufficient formation and action of dopamine in the striatum. Approximately one person in every 500 in the UK has PD and 3 million people in the industrialised countries. The size of the global market for PD treatments is approximately £3 billion annually and is expected to double in the next 10 years principally due to an ageing population.

Notes to Editors 

Phytopharm plc

Phytopharm is a pharmaceutical development and functional food company. We develop products in areas of high unmet health needs, to deliver treatments for longer, healthier lives. Our products are developed from medicinal plants with a history of use, thereby reducing the development risk.  As a virtual company, Phytopharm's model is centred on a lean cash burn with all laboratory, manufacturing and clinical work out-sourced to specialists, while core competencies such as strategy and management are maintained in-house. Close collaboration with charitable organisations enhances our interaction with worldwide specialists and accelerates our development programmes increasing their value.

Pharmaceutical products

Cogane™ is in clinical development as a treatment for Parkinson's disease and Alzheimer's disease and in preclinical evaluation for Huntington's disease. 

Myogane™ is in clinical development as a treatment for ALS (also known as Lou Gehrig's disease).

Functional Foods

Hoodia extract is a weight management functional food product based on an extract of the succulent plant, Hoodia. 

Phytopica® is a natural, three plant product for canine skin health 

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 release. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events of 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.

Phytopharm is listed on the London Stock Exchange, trading symbol PYM.

For further information about Phytopharm please see our website www.phytopharm.com