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Faust Pharmaceuticals Present Phase IIa
Results for Parkinson's Disease
Faust Pharmaceuticals' Phase IIa Results for
Parkinson's Disease Presented at International Congress of Parkinson's Disease
and Movement Disorders
Faust's lead molecule, FP0011, exhibited a differentiated combination of
therapeutic effects and good tolerance in mid- to late-stage patients
Strasbourg, France, June 6, 2007 - Faust Pharmaceuticals S.A., a clinical
stage product company specializing in the discovery and development of drugs for
diseases of the nervous system, today announced that the Phase IIa clinical
trial results of its small molecule glutamate release inhibitor, FP0011, are
being presented at the Movement Disorder Society (MDS)'s 11th International
Congress of Parkinson's Disease and Movement Disorders, taking place this week
in Istanbul, Turkey. The poster, presented by the study's Principal
Investigator, Olivier Rascol, M.D., of University Hospital, Toulouse, has been
selected for presentation at the Highlights of Posters session during the
conference.
In the trial, FP0011 was well tolerated and improved Parkinsonian symptoms as
measured by the Unified Parkinson's Disease Rating Scale (UPDRS), as well as
motor fluctuations as measured by patient diaries. The compound had positive
effects in three critical areas: "core" Parkinsonian motor symptoms (such as
tremor, rigidity and akinesia), axial symptoms not sensitive to L-dopa and other
commonly-prescribed dopaminergic drugs (such as disturbance of posture, balance
and gait), and dyskinesia (i.e. the jerky uncontrolled movements that result as
a side effect of long term L-dopa therapy).
The Phase IIa trial was conducted according to an innovative "n of 1" trial
design in which a small population (n=8) of mid-to-late stage Parkinsonian
patients with L-dopa-induced motor complications were administered FP0011 or
placebo over 4 cross-over periods on a randomized, blinded basis.
Professor Rascol, Dr. Joaquim Ferreira (Lisbon), and Dr. Lucette Lacomblez
(Paris), were principal investigators in this Phase II trial. The "n of 1" trial
design was previously used by Dr. Ferreira to confirm that amantadine,
originally developed as an antiviral and now commonly used to address side
effects of L-dopa therapy, could help Parkinson's patients.
"The differentiated profile observed in this Phase II trial is interesting and
intriguing as there are currently no other drugs with this combination of
therapeutic effects," said Professor Rascol. "Particularly if the therapeutic
effect on non-levodopa sensitive symptoms can be confirmed in the Phase IIb and
subsequent trials, the compound would address a very important unmet medical
need for all mid-to-late stage patients developing postural disturbances, and
could represent a significant advance in approaches to Parkinson's disease."
Also being presented at the conference is a poster on the results of FP0011 in a
MPTP macaque monkey model of Parkinson's disease, by Dr. Jonathan Brotchie, CEO
of Atuka Ltd. of Toronto, Canada. In this trial, monkeys that have developed
dyskinesia from the administration of L-dopa to treat Parkinsonian symptoms from
the neurotoxin, MPTP, were administered FP0011. FP0011 reduced the severity of
L-dopa-induced dyskinesia while extending the duration of the anti-Parkinsonian
action of L-dopa.
"Unlike other drugs on the market that increase the duration of L-dopa action,
FP0011 did not exacerbate the problem of dyskinesia," said Dr. Brotchie. "If
these effects were seen in patients, then over the course of a day such an
action could significantly enhance the quality of life of people with advanced
Parkinson's disease."
Commenting on these presentations, Thomas Seoh, CEO of Faust noted that: "These
mutually supportive data in the Phase IIa trial and the MPTP monkey trial
presented at this conference strongly support the further clinical development
of FP0011 as an adjunctive therapy to L-dopa in patients with established motor
complications. We look forward to confirming and extending these results in
larger trials for Parkinson's patients. Ultimately, we hope to demonstrate that
FP0011 can be a potent, safe glutamate release inhibitor that could have a role
in other neurological diseases and conditions where excess glutamate has been
implicated, such as Alzheimer's disease, ALS, Huntington's disease, multiple
sclerosis and neuropathy."
About Parkinson's disease
Parkinson's disease affects both men and women in almost equal numbers with
no apparent social, ethnic, economic or geographic links. In the United States,
it is estimated that 60,000 new cases are diagnosed each year, joining the 1.5
million Americans who currently have Parkinson's disease. While the condition
usually develops after the age of 65, 15% of those diagnosed are under 50.
Estimates range up to about 1,200,000 patients in Europe.
About Faust Pharmaceuticals -
www.faustpharma.com
Faust Pharmaceuticals is a clinical stage products company specializing in the
discovery and development of drugs for diseases of the nervous system. The
company's lead compound, FP0011, is a small molecule glutamate inhibitor in
Phase II for Parkinson's disease and ALS. A second compound, FP0023, is a fetal
gene activating utrophin inducer in preparation for Phase I/II for Duchenne
Muscular Dystrophy. The company additionally has pre-clinical programs on
targets such as mGluR (metabotropic glutamate receptor), as well as a
proprietary drug discovery platform targeting GPCRs (G-Protein Coupled
Receptors).
For further information, please contact:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
allo@ala.com /
neil@ala.com
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