Research Update
Phytopharm PLC
30 July 2007
Company Contact: U.K. Investor Relations Contact:
Phytopharm plc FD
Dr Daryl Rees CEO David Yates
Piers Morgan CFO Ben Atwell
+44 1480 437 697 +44 207 831 3113
www.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 successfully
completed a Phase Ib healthy volunteer clinical study for MyoganeTM. MyoganeTM
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 MyoganeTM. 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). MyoganeTM
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 MyoganeTM 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 MyoganeTM
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 MyoganeTM, 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.
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
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
This information is provided by RNS
The company news service from the London Stock Exchange