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20 Apr 2009 07:00
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Commencement ofΒ ClinicalΒ Study of Coganeβ’Β inΒ Patients with Parkinson's disease
GODMANCHESTER, Cambridgeshire, UK,Β 20Β AprilΒ 2009,Β Phytopharm plc todayΒ announcesΒ theΒ commencement of aΒ safety, tolerability and pharmacokinetic (PK) study of its orally active neurotrophic factorΒ inducerΒ PYM50028 (Coganeβ’),Β which will involve both healthy volunteers and patients with Parkinson's diseaseΒ (PD). This follows approvalΒ from the Medicines and Healthcare Products Regulatory AgencyΒ (MHRA)Β andΒ ResearchΒ EthicsΒ Committee to commence recruitmentΒ for theΒ UKΒ study.Β
In pre-clinical models, Coganeβ’ reverses the changes in the area of the brain involved in Parkinson'sΒ disease by inducing the body's own production of proteins known as neurotrophic factors. In particular, oneΒ of these factors known as "GDNF" has been shown to be particularly effective in re-growing damagedΒ nerves. Since GDNF is a protein it cannot be given orally (in pill or liquid form) because it is degraded inΒ the stomach and intestine, and also does not readily cross the blood-brain barrier. GDNF can work onlyΒ when injected into or when produced inside the brain. Direct injection of GDNF into the area of the brainΒ involved in Parkinson's disease has shown substantial beneficial effects in small-scale clinical studies butΒ requires highly complex and difficult surgical procedures. Coganeβ’, which can be taken orally, readilyΒ crosses the blood-brain barrier and stimulates the release of GDNF in the brain and therefore has theΒ potential to overcome many of the difficulties associated with GDNF administration.Β
The current study, to beΒ conducted on a partΒ residential, partΒ out-patient basis,Β will employ a randomised, double-blind, multiple dose-ascending, placebo-controlled design to evaluate the safety,Β tolerability and PK profile ofΒ a new oral solution formulation ofΒ Coganeβ’Β when takenΒ forΒ up toΒ 28 daysΒ atΒ variousΒ dose levels. In total, 18Β healthy male and female volunteersΒ and up to 18 male and female patients withΒ PDΒ agedΒ betweenΒ 40-80 years,Β are planned toΒ be enrolled with doses being escalated sequentially following a safety review at each dose level.
The primary objective of thisΒ study is to confirmΒ theΒ safety and tolerabilityΒ of Coganeβ’Β in healthy subjects andΒ PD patients when administered at these dose levels for up to 28 days, the secondary objective being to determine the plasma PK profileΒ ofΒ Coganeβ’Β in these subjects.
Significantly,Β theΒ range of doses to be administered in this study hasΒ beenΒ selected toΒ target plasma levels of Coganeβ’Β equatingΒ toΒ therapeutically relevantΒ concentrationsΒ in preclinical disease models. The PK data from this study should facilitate dose selection for aΒ Phase IIb proof-of-concept study in PD patients.
MrΒ Sandy Morrison, Interim CEO of Phytopharm, commented:Β "Pre-clinical studies with Coganeβ’ have been highly encouraging in reversing the changes in the area of the brain involved in Parkinson's disease.Β We are very pleased to haveΒ commenced thisΒ safety, tolerability and pharmacokineticΒ study of Coganeβ’Β and look forward to reporting the results of this trial and continuing the developmentΒ of an orally administeredΒ product that can stimulate production of GDNF in the brain, thusΒ overcomingΒ the difficult surgical problems associated with direct GDNF injection into the brain."
Dosing of the first group ofΒ enrolledΒ subjectsΒ has commencedΒ with enrolment expected to be completed in Q3Β ofΒ this yearΒ and the results reported in Q4.
-Ends-
Notes to Editors
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Enquiries Phytopharm plc Sandy Morrison, Interim CEO +441480 437 697 Keith Thomson Interim COO +44 1480 437 697 |
U.K. Investor Relations FD Ben Atwell John Dineen +44 207 831 3113 |
Phytopharm plc
Phytopharm is a pharmaceutical development and functional food company. Our products are developed from medicinal plants, thereby reducing the development risk, cost and time to market. 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 Key Opinion Leaders and accelerates our development programmes increasing their value.
Coganeβ’
Coganeβ’ (PYM50028) is a novel non-peptide, orally bioavailable neurotrophic factor inducer that readily crosses the blood brain barrier. In pre-clinical studies, Coganeβ’ stimulates the release of neuronal growth factors such as GDNF, increases neurite outgrowthΒ andΒ protectsΒ against neuronal degeneration. Importantly, Coganeβ’ alsoΒ reversesΒ the decrease of GDNF andΒ reversesΒ dopaminergic neuronal degeneration observedΒ in vitroΒ andΒ in vivo. When administered orally to pre-clinical models of Parkinson's disease, Coganeβ’ reverses the loss of dopaminergic neurones.
The Michael J. Fox FoundationΒ
TheΒ Michael J. Fox FoundationΒ fundingΒ is supporting ourΒ preclinical studies to determine the optimal dosing requirements for Coganeβ’ andΒ is beingΒ carried out by Dr Jonathan Brotchie,Β a Senior Scientist at theΒ TorontoΒ WesternΒ HospitalΒ and part of the University Health Network (UHN) inΒ Toronto,Β Canada. Dr Brotchie is a recognised expert in the field of Parkinson's disease.Β Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring theΒ development of a cure for Parkinson's disease within this decade through an aggressively funded researchΒ agenda. The Foundation has funded $112 million in research to date. More information on the Foundation isΒ available atΒ www.michaeljfox.org.
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 of an area of the brain,Β the striatum, responsible for the control of movement. This is caused by degeneration of dopaminergic neurones between theΒ striatumΒ and theΒ substantia nigraΒ 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 the disease is estimated to be 100 to 200 per 100,000 population (Source: Datamonitor). In the US alone, there are estimated to be one million patients with diagnosed Parkinson's disease with associated healthcare costs to the economy 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. Individuals will experience varying combinations of the symptoms, each with differing degrees of severity. The cause of Parkinson's disease in the majority of cases is unknown (idiopathic Parkinson's disease), though some cases have been found to have a hereditary component (familial Parkinson's disease) and possible mechanisms include oxidative damage of nerve cells coupled with loss of neurotrophic factors. Neurotrophic factors such as GDNF are essential for the survival and maintenance of nerve cells and provide protection against toxic insults, however as proteins, their utility as pharmacological treatments are limited (Source: Michael J. Fox Foundation for Parkinson's Research).
At present, there is no cure for Parkinson's disease, but a variety of medications provide relief from the symptoms, usually by dopamine replacement therapy either by L-DOPA, which is converted to dopamine in theΒ striatum, or by dopamine agonists which act on the dopamine receptors to restore normal motor function (control of movement). However, both treatments cause either less dopamine to be released by the brain or the dopamine receptors to become progressively less sensitive, thereby eventually increasing the symptoms of the underlying Parkinson's disease. There is an urgent need for the development of new approaches to this debilitating condition and non-peptide orally bioavailable neurotrophic factor inducers which readily cross the blood brain barrier represent an important new therapeuticΒ approach.
For further information about Phytopharm please see our website atΒ http://www.phytopharm.com
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