Successful Completion of Phase Ib Clinical Study for Myogane



GODMANCHESTER, England, (30 July 2007) - Phytopharm plc (LSE: PYM) ("Phytopharm" or the "Company") announces today that it has successfully completed a Phase Ib healthy volunteer clinical study for Myogane(tm). Myogane(tm) is a novel orally active neurotrophic factor inducer being developed for orphan motor neurone diseases of which the most prevalent form is amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease).




This residential healthy volunteer clinical study utilised a randomised, double blind, placebo-controlled design with a liquid formulation of Myogane(tm). ALS patients have difficulty in swallowing and this new formulation optimises ease of use for the patient. The study demonstrated a good safety, tolerability and pharmacokinetic profile following single oral doses escalated across groups of healthy adult subjects. Encouragingly, the highest dose administered (640 mg) was well tolerated with no adverse events and demonstrated an excellent absorption profile.


The study was conducted in the UK under a clinical trial authorisation (CTA) from the Medicines and Healthcare Products Regulatory Agency (MHRA). Myogane(tm) has previously been granted Orphan Drug and Fast Track designation for the treatment of ALS by the United States Food and Drug Administration (FDA). Phytopharm intends to request EU orphan medicinal product status during the fourth quarter of 2007 to enable the most efficient and rapid clinical progress of Myogane(tm) for this devastating condition.


ALS is a fatal neurodegenerative disease characterised by progressive degeneration of both upper and lower motor neurones which lead to severe muscle weakness and wasting followed by paralysis. Approximately 350,000 patients suffer from ALS world wide, of which 50% die within 18 months of diagnosis. This condition has a high unmet medical need (source: Datamonitor).


Commenting on today's announcement, Dr Brian Dickie, Director of Research Development, MND Association, said: "There is an urgent need for new therapeutic approaches to motor neurone disease. Potential treatments such as Myogane(tm) that can readily access the central nervous system and induce a person's own neurotrophic factor activity offer the potential to alter disease progression. Clinical trials in patients are now needed to validate this novel therapeutic approach."


Commenting on today's announcement, Dr Daryl Rees, Chief Executive Officer of Phytopharm, said: "Pre-clinical studies with Myogane(tm), our novel orally bioavailable neurotrophic factor inducer, have been highly encouraging in both quality of life and survival parameters. We are pleased that our new liquid formulation has demonstrated such a good safety, tolerability and absorption profile and we look forward to further clinical progress."


-Ends-


Notes to Editors


Phytopharm plc

Phytopharm is a pharmaceutical development and functional food company whose product leads are generated from medicinal plants. The Company's strategy is to develop these products through 'proof of principle' clinical testing, and then secure partners for late stage development, sales and marketing. Laboratory, manufacturing and clinical work is outsourced to selected specialists, operating under expert in-house management. This operational structure allows access to the best external research facilities whilst maintaining low fixed overheads and a lower development cost structure.


Myogane(tm)

Myogane(tm) is a novel non-peptide, orally bioavailable neurotrophic factor inducer that readily crosses the blood brain barrier. In pre-clinical studies, Myogane(tm) stimulates the release of neuronal growth factors, increases neurite outgrowth and protects against oxidative and glutamate neuronal damage. Myogane(tm) also reverses the decrease of neuronal growth factors, reverses oxidative and glutamate damage and reverses neuronal degeneration observed in motor neurones in vitro. When administered orally to pre-clinical models of ALS, Myogane(tm) delays the loss of muscle strength and extends survival time.


The neuroprotective and neurotrophic actions of Myogane(tm) suggest potential beneficial effects in other orphan neurodegenerative diseases including Friedrich's ataxia, progressive supranuclear palsy, Huntington's disease and multiple system atrophy as well as several niche market diseases.


Motor Neurone Disease

Amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease) is the most prevalent form of motor neurone disease which generally strikes people between 40 and 60 years of age. It is characterised by progressive loss of both lower (spinal cord and brainstem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure.


ALS is considered an orphan disease (i.e. the condition is rare) as it affects fewer than 200,000 in the US (US definition) and affects no more than 5 in 10,000 people (EU definition). Approximately 350,000 patients suffer from ALS world wide, of which 50% die within 18 months of diagnosis. In recent years, there is evidence that the incidence of motor neurone disease is increasing although this may be due to more accurate testing and diagnosis (source Motor Neurone Disease Association). The financial cost to families of patients is exceedingly high, and it is estimated that in the advanced stage, care can cost an average of $200,000 per year (source: International Alliance of ALS Associations).


The precise causes of motor neurone degeneration in ALS patients remain unknown. Approximately 5-10% of cases appear to be of familial origin and possible mechanisms include loss of neurotrophic factors coupled with oxidative and glutamate mediated damage of nerve cells. Neurotrophic factors 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. Riluzole (Rilutek(tm)), a glutamate modulator, is the only agent indicated for the treatment of this condition and increases average survival by only a few months (source Datamonitor). There is an urgent need for the development of new approaches to this devastating condition and non-peptide orally bioavailable neurotrophic factor inducers that readily cross the blood brain 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 and promote research to help bring about an end to the disease. Until then, it does all 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 is also dedicated to supporting the families and carers of people with MND.


The MND Association's Research Foundation is committed to raising the funds needed to support national and international research efforts to end MND. Funds raised by the Research Foundation will drive science forward, so that a cure can be found and MND will be beaten. Until that day comes, the Research Foundation is equally committed to funding research that improves the lives of people living with MND. For further information about the MND Association please visit http://www.mndassociation.org



Gemma Cross Brown Assistant Financial Communications

FD <http://www.fd.com/>

Holborn Gate, 26 Southampton Buildings London, WC2A 1PB

T +44 (0)20 7269 7125 F +44 (0)20 7242 8695 M +44 (0)7786 074 515 www.fd.com

Company Contact:

Phytopharm plc

Dr Daryl Rees CEO

Piers Morgan CFO

+44 1480 437 697

www.phytopharm.com


U.K. Investor Relations Contact:

FD

David Yates

Ben Atwell +44 207 831 3113

http://www.pharmalive.com/News/index...&categoryid=21