Y llegará lo que se espera!!!

Se va por el buen camino, parece.

Cariños

Cristina



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De: xfragil@yahoogroups.com [mailto:xfragil@yahoogroups.com] En nombre de
GARCIA JOSE ALBERTO
Enviado el: lunes, 10 de marzo de 2008 12:59
Para: xfragil@yahoogroups.com
Asunto: [xfragil] FASE II



Se ha iniciado la Fase II del tratamiento con FENOBAM, la I ya fue
superada. Sigamos cruzando los dedos.

Alberto

__________________________________________________________
____

Phase II Human Trial of Fenobam is Underway

In December we announced that an initial Phase 1 trial of fenobam in
normal volunteers had started. That trial has been completed
successfully, and a Phase II trial of fenobam in patients with Fragile X
has begun.


Neuropharm and FRAXA Research Foundation are working together to
explore the potential of the mGluR5 antagonist fenobam to treat Fragile
X Syndrome. Neuropharm, a speciality pharmaceutical company focused on
neurodevelopmental disorders, received Orphan Drug Designation in
November 2006 for fenobam to treat Fragile X, after acquiring rights to
relevant data on the compound from FRAXA. The Orphan Drug Act aims to
speed up development of treatments for rare diseases, defined as
affecting 200,000 or fewer U.S. residents, like Fragile X.


Fragile X Syndrome is the most common inherited cause of mental
impairment and autism. Its symptoms include intellectual handicap,
hyperactivity, attention problems, autistic features, emotional
liability and epilepsy. There is currently no effective treatment for
the condition.


This Phase II trial is being conducted in the US by Professor Randi
Hagerman from the UC Davis MIND Institute
(www.ucdmc.ucdavis.edu/mindinstitute/) and Professor Elizabeth
Berry-Kravis from Rush University Medical Center ( www.rush.edu/). Since
mGluR5 antagonists have not been given to people with Fragile X before,
this first study will use a single dose of fenobam in each patient. The
outcome of this investigation will determine the feasibility of
longer-term studies with fenobam.


Robert Mansfield, Neuropharm's CEO, commented: "We are delighted to
announce the commencement of this study with Professors Hagerman and
Berry-Kravis who are world leading experts in the clinical study of
Fragile X Syndrome. Their trial of NPL-2009 (fenobam), a targeted
treatment for Fragile X Syndrome, is a milestone for those affected by
this condition. This study follows the work of FRAXA, and researchers
such as Dr. Mark Bear, which has highlighted the potential of mGluR5
receptor antagonists for this patient group."

News on this program will be posted on the following websites:
clinicaltrials.gov (ClinicalTrials.gov)
fraxa.org (FRAXA Research Foundation)
neuropharm.co.uk (Neuropharm)

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