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Fovea Pharmaceuticals Receives Orphan Drug Designation From EC For RdCVF For The Treatment Of Retinitis Pigmentosa
Fovea Pharmaceuticals SA, which, last
December 2007, raised $44M in a Series B financing, announced that
its product, Recombinant human rod-derived cone viability factor
(rh-RdCVF), has received designation as Orphan Medicinal Product from the
European Commission, following the positive opinion from the European
Agency for the Evaluation of Medicinal Products (EMEA) Committee for Orphan
Medicinal Product (COMP) for the treatment of retinitis pigmentosa, a
genetic disease leading to progressive loss of vision. Fovea is currently
conducting pre-clinical studies of RdCVF and has demonstrated efficacy in
animal model of the disease.
Orphan drug designation would entitle Fovea to exclusive marketing
rights in the European countries for ten years should Fovea be the first
company to receive marketing approval for this type of therapeutic drug
product. In addition, the designation would allow Fovea to apply for
research funding, tax credits for certain research expenses, and protocol
assistance. Similar orphan drug designation is currently being assessed in
the USA by the Food and Drug Administration (FDA).
"We are pleased to have received this orphan drug designation for RdCVF
in the treatment of retinitis pigmentosa," said Bernard Gilly, Chairman and
Chief Executive Officer of Fovea. "This designation is a recognition of the
quality of our work and will also provide us with financial and regulatory
benefits in addition to market exclusivity."
In a study on animal model of the disease performed at INSERM U592 in
Paris (Pr. Jose Sahel's team) RdCVF was shown to improve the survival and
the functionality of retinal cone cells that are responsible for central
vision and that are degenerating in patients suffering from this disease.
Fovea is conducting further studies to produce RdCVF and plans to start
clinical trials in 2009.
About Retinitis Pigmentosa
RP is a long lasting disease that slowly evolves towards irreversible
blindness. Classically in affected people, the retinal rod photoreceptors
responsible for night vision and side vision slowly degenerate, first
leading to night blindness. As the disorder progresses, the cone
photoreceptors degenerate also and their loss is responsible of a narrowing
of the peripheral field of vision which progressively worsens to become
"tunnel-like". During the last phase of the disease, the central vision can
decrease until the patient becomes blind.
RP usually appears in teenagers and young adults but may sometimes be
present from early childhood and generally progresses over several decades.
However, in extreme cases the disease may evolve rapidly over two decades.
In the European Community, 150 000 patients are affected by this disorder.
RP is a genetic disorder. The inheritance pattern is variable and can
be either autosomal dominant, autosomal recessive or X-linked recessive.
Most genes for RP cause only a small proportion of cases, exceptions being
the rhodopsin gene, which leads to about 25% of dominant RP. Overall,
approximately 40% of cases of RP are due to genes that are as yet
undiscovered.
About RdCVF
RdCVF (Rod derived Cone Viability Factor) is a protein that is produced
by the rods and is necessary for the functionality and the survival of the
cones. RdCVF was first identified by Pr. José Sahel's team at INSERM U592.
The original work was published in Nature Genetics in 2004.
In RP, preventing cone cell death is a very promising therapeutic
approach as vision can remain substantial in patients with 95% cone loss.
This offers greater hope for a positive outcome from a strategy aimed at
preserving the remaining cones in RP patients and simultaneously broadens
the window for therapeutic intervention.
About FOVEA Pharmaceuticals
Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical
company specialized in development and commercialization of drugs for the
treatment of ocular diseases, with a special focus on retinal pathologies.
Created in May 2005, Fovea has a highly experienced board and management
team. Last December 2007, it raised EUR30M ($44M) in a Series B financing
from a strong, international syndicate of new and existing investors led by
Forbion Capital Partners (Naarden, The Netherlands). All existing
institutional investors participated in the round including Sofinnova
Partners, Abingworth, GIMV, The Wellcome Trust and Credit Agricole Private
Equity (CAPE).
Fovea has built a project portfolio including internal research
programs on dry AMD, glaucoma (neuroprotection) and retinal dystrophies as
well as clinical programs underway for such indications as macular edema,
allergic conjunctivitis, and retinitis pigmentosa.
To advance the development and commercialization of its programs, FOVEA
is working both independently and through collaborators including
industrial partners like Novartis, Genzyme, and CombinatoRx, as well as
with academic teams, like the Inserm unit U592, the Rothschild
Ophthalmological Foundation, or the Johns Hopkins University.
For additional information about FOVEA and its programs, please visit
http://www.fovea-pharma.com
Fovea Pharmaceuticals SA
http://www.fovea-pharma.com
Fovea Pharmaceuticals Primeºte Orphan Drug Desemnarea de la CE pentru RdCVF pentru tratamentul retinitã Pigmentosa - Fovea Pharmaceuticals Receives Orphan Drug Designation From EC For RdCVF For The Treatment Of Retinitis Pigmentosa - articole medicale engleza - startsanatate