Protalix BioTherapeutics to Present Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry...
September 17 2018 - 7:00AM
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX),
a biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins expressed
through its proprietary plant cell-based expression system,
ProCellEx®, today announced that the Company will present
preliminary data from the BRIDGE study of pegunigalsidase alfa for
the treatment of Fabry disease at the 1st Canadian Symposium on
Lysosomal Diseases 2018. The conference will take place
October 5-6, 2018 at the OTL Gouverneur Hotel in Sherbrooke,
Quebec.
An oral presentation titled, “Pegunigalsidase Alfa-a Novel
Enzyme Replacement Therapy for the Treatment of Fabry Disease:
Preliminary Results from the Phase III Bridge Study,” will be
presented by Dr. Michael L. West, Professor of Medicine and
Assistant Dean of Clinical Trial Research, Dalhousie University,
Halifax, Nova Scotia and Director of the Nova Scotia Fabry Disease
Clinic on Friday, October 5 at 10:15 am ET.
Pegunigalsidase alfa, or PRX-102, is the Company’s plant
cell-expressed recombinant, PEGylated, cross-linked
α-galactosidase-A candidate for the treatment of Fabry disease.
The BRIDGE study is an open-label, single arm switch-over
study to assess the safety and efficacy of pegunigalsidase alfa, 1
mg/kg infused every two weeks, in Fabry patients currently treated
with Replagal®. The data to be presented will include kidney
function for the first 16 patients who have completed six months of
treatment with PRX-102.
A copy of the oral presentation will be available on Protalix’s
website under the Presentation tab in the Investors section
following the conference.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based
expression system, ProCellEx®. Protalix’s unique expression
system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale manner.
Protalix’s first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the U.S. Food and Drug
Administration (FDA) in May 2012 and, subsequently,
by the regulatory authorities of other countries. Protalix
has licensed to Pfizer Inc. the worldwide development and
commercialization rights for taliglucerase alfa,
excluding Brazil, where Protalix retains full rights.
Protalix’s development pipeline includes the following product
candidates: pegunigalsidase alfa, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry
disease; OPRX-106, an orally-delivered anti-inflammatory treatment;
alidornase alfa for the treatment of Cystic Fibrosis; and
others. Protalix partnered with Chiesi Farmaceutici S.p.A.,
both in the United States and outside the United
States, for the development and commercialization of
pegunigalsidase alfa.
Investor Contact
Marcy Nanus, Managing Director Solebury Trout
646-378-2927mnanus@soleburytrout.com
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