Ixico Regulatory News (IXI)

17 May 2007 07:01

Phytopharm PLC17 May 2007 Company Contact: U.K. Investor Relations Contact:Phytopharm plc FDDr Daryl Rees CEO David YatesMr Piers Morgan CFO Ben Atwell+44 1480 437 697 +44 207 831 3113www.phytopharm.com Commencement of Phase Ib clinical study for MyoganeTM GODMANCHESTER, Cambridgeshire, U.K. (17 May 2007) - Phytopharm plc (LSE: PYM) ("Phytopharm" or the "Company") announces today that it has been granted clearancefrom the Medicines and Healthcare Products Regulatory Agency (MHRA) and receivedResearch Ethics Committee (REC) approval to commence a Phase Ib healthyvolunteer clinical study for MyoganeTM in the UK. MyoganeTM is a novel orallyactive neurotrophic factor inducer being developed for amyotrophic lateralsclerosis (ALS, also known as Lou Gehrig's disease), the most prevalent form ofmotor neurone disease. This residential healthy volunteer clinical study utilises a randomised, doubleblind, placebo-controlled design with a new liquid formulation of MyoganeTM.ALS patients have difficulty in swallowing and this new formulation aims toprovide optimal ease of use for the patient. The study will evaluate thesafety, tolerability and pharmacokinetic profile of single oral doses escalatedacross groups of healthy adult subjects. It is expected that the results will bereported during the third quarter of 2007. Phytopharm has already successfully completed a Phase Ia healthy volunteerclinical study with MyoganeTM formulated as a capsule which demonstrated anexcellent overall safety profile for the product. The study was conducted underan investigational new drug (IND) with the United States Food and DrugAdministration (FDA) who also granted Orphan Drug and Fast Track designation toMyoganeTM for the treatment of ALS. 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 Daryl Rees, Chief Executive Officer ofPhytopharm, said: "There is an urgent need for new therapeutic approaches tomotor neurone diseases such as ALS. Pre-clinical studies with MyoganeTM, ournovel orally bioavailable neurotrophic factor inducer, have been highlyencouraging in both quality of life and survival parameters. We are pleased toprogress our new liquid formulation into the clinic and anticipate requesting EUorphan medicinal product status during the fourth quarter of 2007 as this willenable the most efficient and rapid clinical progress of MyoganeTM for thisdevastating condition." -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 This information is provided by RNS The company news service from the London Stock Exchange