Press Release Source: Newron Pharmaceuticals SpA


Newron Pharmaceuticals Completes Enrollment in Safinamide Phase III
Pivotal Clinical Trial for Parkinson's Disease
Thursday July 21, 4:00 am ET


MILAN, Italy, July 21 /PRNewswire/ -- Newron Pharmaceuticals SpA, a
research and development company focused on novel CNS therapies, today
announced the completion of patient enrollment in its phase III trial
with Safinamide for the treatment of Parkinson's disease. Phase III
testing is the final stage before submission to health regulatory
authorities. A total of 260 patients in 26 centres worldwide have been
randomised in the study, which aims to show efficacy and safety of
safinamide used as adjunctive treatment to a dopamine agonist in patients
with early-stage Parkinson's disease.

"Completing patient enrollment on schedule in our first phase III trial
is a major achievement for Newron. We anticipate data from the study to
be available in the first half 2006," commented Dr Luca Benatti, CEO of
Newron Pharmaceuticals. "We will now accelerate the implementation of
additional trials to allow regulatory filing of Safinamide worldwide".

Safinamide Phase III Study

The phase III trial has been designed as a double-blind,
placebo-controlled, parallel-group, randomized, multi-national study
during which patients will receive treatment for 18 months. Early-stage
Parkinson's disease outpatients enrolled in the trial will receive a
stable dose of a single dopamine agonist and, as an add-on therapy, one
of two non-overlapping dose ranges of orally administered Safinamide
(50-100, or 150-200 mg/day) or placebo. Patients enrolled and completing
an initial 6-month of double-blind treatment will be eligible to enter a
12-month, double-blind continuation study. The primary efficacy measures
will be the change from baseline to endpoint in mean value of UPDRS
(Unified Parkinson's Disease Rating Scale) - Section III (motor score)
and the CGI (Clinical Global Impression change from baseline to
endpoint). The UPDRS and the CGI are specialised scoring systems used to
rate the clinical severity and response to treatment in Parkinsonian
patients, respectively.

The continuation study will measure the time for which the effect of
Safinamide is maintained in these patients.

About Parkinson's Disease

Parkinson's disease is one of the major neurological disorders, affecting
approximately 4 million people worldwide, according to the World Health
Organisation. It is characterised as a chronic, progressive degeneration
of nerve cells that use the neurotransmitter dopamine in a special area
of the brain, called the Substantia Nigra (black substance) that controls
muscle tone, initiation and smoothness of movements. Symptoms include
limb tremors, muscle rigidity, slowness of motion and postural
instability. Current treatments aim at replenishing the lost stores of
dopamine or stimulating those dopamine receptors that carry forward
dopamine motor messages.

About Safinamide

Safinamide is an investigational new drug currently in phase III clinical
trials for the treatment of Parkinson's disease and in phase II for
epilepsy and Restless Leg Syndrome (RLS). Safinamide is a unique molecule
with multiple mechanisms of action, including potentiation of dopamine
via inhibition of monoamine oxidase (MAO)-B and dopamine re-uptake and
glutamate release inhibition. Safinamide has demonstrated robust efficacy
in phase II clinical trials for Parkinson's disease. The development of
Safinamide in Parkinson's disease is supported in part by a EUR2.7
million grant from the Italian Ministry of Productive Development's
Innovation Technology Fund.

About Newron Pharmaceuticals S.p.A.

Newron Pharmaceuticals S.p.A (http://www.newron.com) is a research and
development company focused on novel ion channel based therapies for
diseases of the Central Nervous System (CNS), particularly Parkinson's
disease, epilepsy and pain. Newron has initiated phase III trials with
Safinamide, a unique molecule with multiple mechanisms of action, for the
treatment of Parkinson's disease. Phase II trials with Safinamide in
Epilepsy and Restless Leg Syndrome (RLS) are also ongoing. Newron is also
conducting phase II trials with Ralfinamide, a potent sodium channel
blocker, for the treatment of neuropathic pain. Newron's clinical
pipeline is supported by a broad portfolio of early stage proprietary
compounds generated by its ion channel drug discovery platform. Newron is
headquartered in Bresso, near Milan, Italy.
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Source: Newron Pharmaceuticals SpA
http://biz.yahoo.com/prnews/050721/ukw015.html?.v=14

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