Research Update
Phytopharm PLC
17 May 2007
Company Contact: U.K. Investor Relations Contact:
Phytopharm plc FD
Dr Daryl Rees CEO David Yates
Mr Piers Morgan CFO Ben Atwell
+44 1480 437 697 +44 207 831 3113
www.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 clearance
from the Medicines and Healthcare Products Regulatory Agency (MHRA) and received
Research Ethics Committee (REC) approval to commence a Phase Ib healthy
volunteer clinical study for MyoganeTM in the UK. MyoganeTM is a novel orally
active neurotrophic factor inducer being developed for amyotrophic lateral
sclerosis (ALS, also known as Lou Gehrig's disease), the most prevalent form of
motor neurone disease.
This residential healthy volunteer clinical study utilises a randomised, double
blind, placebo-controlled design with a new liquid formulation of MyoganeTM.
ALS patients have difficulty in swallowing and this new formulation aims to
provide optimal ease of use for the patient. The study will evaluate the
safety, tolerability and pharmacokinetic profile of single oral doses escalated
across groups of healthy adult subjects. It is expected that the results will be
reported during the third quarter of 2007.
Phytopharm has already successfully completed a Phase Ia healthy volunteer
clinical study with MyoganeTM formulated as a capsule which demonstrated an
excellent overall safety profile for the product. The study was conducted under
an investigational new drug (IND) with the United States Food and Drug
Administration (FDA) who also granted Orphan Drug and Fast Track designation to
MyoganeTM for the treatment of ALS.
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 Daryl Rees, Chief Executive Officer of
Phytopharm, said: 'There is an urgent need for new therapeutic approaches to
motor neurone diseases such as ALS. Pre-clinical studies with MyoganeTM, our
novel orally bioavailable neurotrophic factor inducer, have been highly
encouraging in both quality of life and survival parameters. We are pleased to
progress our new liquid formulation into the clinic and anticipate requesting EU
orphan medicinal product status during the fourth quarter of 2007 as this will
enable the most efficient and rapid clinical progress of MyoganeTM for this
devastating condition.'
-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.
MyoganeTM
MyoganeTM is a novel non-peptide, orally bioavailable neurotrophic factor
inducer that readily crosses the blood brain barrier. In pre-clinical studies,
MyoganeTM 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, MyoganeTM
delays the loss of muscle strength and extends survival time.
The neuroprotective and neurotrophic actions of MyoganeTM 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 (RilutekTM), 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
This information is provided by RNS
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