Ixico Regulatory News (IXI)

30 Jul 2007 07:00

Phytopharm PLC30 July 2007 Company Contact: U.K. Investor Relations Contact:Phytopharm plc FDDr Daryl Rees CEO David YatesPiers Morgan CFO Ben Atwell+44 1480 437 697 +44 207 831 3113www.phytopharm.com Successful completion of Phase Ib clinical study for MyoganeTM GODMANCHESTER, Cambridgeshire, U.K. (30 July 2007) - Phytopharm plc (LSE: PYM)("Phytopharm" or the "Company") announces today that it has successfullycompleted a Phase Ib healthy volunteer clinical study for MyoganeTM. MyoganeTMis a novel orally active neurotrophic factor inducer being developed for orphanmotor neurone diseases of which the most prevalent form is amyotrophic lateralsclerosis (ALS, also known as Lou Gehrig's disease). This residential healthy volunteer clinical study utilised a randomised, doubleblind, placebo-controlled design with a liquid formulation of MyoganeTM. ALSpatients have difficulty in swallowing and this new formulation optimises easeof use for the patient. The study demonstrated a good safety, tolerability andpharmacokinetic profile following single oral doses escalated across groups ofhealthy adult subjects. Encouragingly, the highest dose administered (640 mg)was well tolerated with no adverse events and demonstrated an excellentabsorption profile. The study was conducted in the UK under a clinical trial authorisation (CTA)from the Medicines and Healthcare Products Regulatory Agency (MHRA). MyoganeTMhas previously been granted Orphan Drug and Fast Track designation for thetreatment of ALS by the United States Food and Drug Administration (FDA).Phytopharm intends to request EU orphan medicinal product status during thefourth quarter of 2007 to enable the most efficient and rapid clinical progressof MyoganeTM for this devastating condition. ALS is a fatal neurodegenerative disease characterised by progressivedegeneration of both upper and lower motor neurones which lead to severe muscleweakness and wasting followed by paralysis. Approximately 350,000 patientssuffer from ALS world wide, of which 50% die within 18 months of diagnosis. Thiscondition has a high unmet medical need (source: Datamonitor). Commenting on today's announcement, Dr Brian Dickie, Director of ResearchDevelopment, MND Association, said: "There is an urgent need for new therapeuticapproaches to motor neurone disease. Potential treatments such as MyoganeTMthat can readily access the central nervous system and induce a person's ownneurotrophic factor activity offer the potential to alter disease progression.Clinical trials in patients are now needed to validate this novel therapeuticapproach." Commenting on today's announcement, Dr Daryl Rees, Chief Executive Officer ofPhytopharm, said: "Pre-clinical studies with MyoganeTM, our novel orallybioavailable neurotrophic factor inducer, have been highly encouraging in bothquality of life and survival parameters. We are pleased that our new liquidformulation has demonstrated such a good safety, tolerability and absorptionprofile and we look forward to further clinical progress." -Ends- Notes to Editors Phytopharm plc Phytopharm is a pharmaceutical development and functional food company whoseproduct leads are generated from medicinal plants. The Company's strategy is todevelop these products through 'proof of principle' clinical testing, and thensecure partners for late stage development, sales and marketing. Laboratory,manufacturing and clinical work is outsourced to selected specialists, operatingunder expert in-house management. This operational structure allows access tothe best external research facilities whilst maintaining low fixed overheads anda lower development cost structure. MyoganeTM MyoganeTM is a novel non-peptide, orally bioavailable neurotrophic factorinducer that readily crosses the blood brain barrier. In pre-clinical studies,MyoganeTM stimulates the release of neuronal growth factors, increases neuriteoutgrowth and protects against oxidative and glutamate neuronal damage. MyoganeTM also reverses the decrease of neuronal growth factors, reverses oxidative andglutamate damage and reverses neuronal degeneration observed in motor neuronesin vitro. When administered orally to pre-clinical models of ALS, MyoganeTMdelays the loss of muscle strength and extends survival time. The neuroprotective and neurotrophic actions of MyoganeTM suggest potentialbeneficial effects in other orphan neurodegenerative diseases includingFriedrich's ataxia, progressive supranuclear palsy, Huntington's disease andmultiple system atrophy as well as several niche market diseases. Motor Neurone Disease Amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease) is themost prevalent form of motor neurone disease which generally strikes peoplebetween 40 and 60 years of age. It is characterised by progressive loss of bothlower (spinal cord and brainstem) and upper (cerebral cortex) motor neurones,which leads to severe muscle weakness and wasting, followed by paralysis anddeath, generally caused by respiratory failure. ALS is considered an orphan disease (i.e. the condition is rare) as it affectsfewer than 200,000 in the US (US definition) and affects no more than 5 in10,000 people (EU definition). Approximately 350,000 patients suffer from ALSworld wide, of which 50% die within 18 months of diagnosis. In recent years,there is evidence that the incidence of motor neurone disease is increasingalthough this may be due to more accurate testing and diagnosis (source MotorNeurone Disease Association). The financial cost to families of patients isexceedingly high, and it is estimated that in the advanced stage, care can costan average of $200,000 per year (source: International Alliance of ALSAssociations). The precise causes of motor neurone degeneration in ALS patients remain unknown.Approximately 5-10% of cases appear to be of familial origin and possiblemechanisms include loss of neurotrophic factors coupled with oxidative andglutamate mediated damage of nerve cells. Neurotrophic factors are essentialfor the survival and maintenance of nerve cells and provide protection againsttoxic insults, however as proteins, their utility as pharmacological treatmentsare limited. Riluzole (RilutekTM), a glutamate modulator, is the only agentindicated for the treatment of this condition and increases average survival byonly a few months (source Datamonitor). There is an urgent need for thedevelopment of new approaches to this devastating condition and non-peptideorally bioavailable neurotrophic factor inducers that readily cross the bloodbrain barrier represent an important therapeutic approach. For further information about Phytopharm please see our website at http://www.phytopharm.com Motor Neurone Disease (MND) Association The MND Association wants to see a world free of MND. The Association fund andpromote research to help bring about an end to the disease. Until then, it doesall that it can to ensure everyone with MND receives the best possible care,achieves the highest quality of life, and dies with dignity. The Association isalso dedicated to supporting the families and carers of people with MND. The MND Association's Research Foundation is committed to raising the fundsneeded to support national and international research efforts to end MND. Fundsraised by the Research Foundation will drive science forward, so that a cure canbe found and MND will be beaten. Until that day comes, the Research Foundationis equally committed to funding research that improves the lives of peopleliving with MND. For further information about the MND Association please visithttp://www.mndassociation.org This information is provided by RNS The company news service from the London Stock Exchange