Protalix BioTherapeutics Announces the Completion of Enrollment in the Phase III BRIDGE Clinical Trial of pegunigalsidase alf...
December 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 the completion of enrollment for the
BRIDGE phase III clinical trial of pegunigalsidase alfa (PRX-102)
for the treatment of Fabry disease. Additionally, the Company
provided an update on the enrollment for the BALANCE and BRIGHT
phase III clinical trials which, collectively with the BRIDGE
study, comprise the phase III clinical development program for
PRX-102 for the treatment of Fabry disease. The BRIGHT study
is approximately 90% enrolled and the BALANCE study is
approximately 70% enrolled.
“In September 2018, we reported encouraging, positive interim
results from the BRIDGE study and look forward to continue
releasing additional data in 2019,” commented Moshe Manor,
Protalix’s President and Chief Executive Officer. “Based on
the promising preliminary BRIDGE study results, and taking into
account the newly issued guidance from the U.S. Food and Drug
Administration (FDA), we plan to meet with
the FDA during the first quarter of 2019 to discuss the
most optimal regulatory path forward for PRX-102. While we
continue to enroll patients in the BRIGHT and BALANCE Fabry disease
studies, we believe that with the patients enrolled across the
studies included in our PRX-102 clinical program to
date, there is a sufficient number of patients to support
expedited review, including the potential for filing an application
for accelerated approval,” continued Mr. Manor.
The BRIDGE study is an open label switch over study evaluating
the safety and efficacy of PRX-102 in patients with Fabry disease
currently treated with agalsidase alfa for at least 2 years and on
a stable dose for at least 6 months. Patients are screened
and evaluated over 3 months while continuing treatment with
agalsidase alfa. Following the screening period, patients are
enrolled and switched from agalsidase alfa treatment to intravenous
(IV) infusions of 1 mg/kg of PRX-102 every two weeks for 12
months.
PRX-102 is the Company’s plant cell-expressed recombinant,
PEGylated, cross-linked α-galactosidase-A product candidate for the
treatment of Fabry disease.
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 has 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.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms “expect,”
“anticipate,” “believe,” “estimate,” “project,” “plan,” “should”
and “intend” and other words or phrases of similar import are
intended to identify forward-looking statements. These
forward-looking statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and
results to differ materially from the statements made. These
statements are based on our current beliefs and expectations as to
such future outcomes. Drug discovery and development involve
a high degree of risk and the final results of a clinical trial may
be different than the preliminary findings for the clinical
trial. Factors that might cause material differences include,
among others: failure or delay in the commencement or completion of
our preclinical and clinical trials which may be caused by several
factors, including: risks that the FDA will not accept an
application for accelerated approval of PRX-102 with the data
generated to date or will request additional data or other
conditions of our submission of any application for accelerated
approval of PRX-102; slower than expected rates of patient
recruitment; unforeseen safety issues; determination of dosing
issues; lack of effectiveness during clinical trials; inability to
monitor patients adequately during or after treatment; inability or
unwillingness of medical investigators and institutional review
boards to follow our clinical protocols; and lack of sufficient
funding to finance clinical trials; the risk that the results of
the clinical trials of our product candidates will not support our
claims of superiority, safety or efficacy, that our product
candidates will not have the desired effects or will be associated
with undesirable side effects or other unexpected characteristics;
risks related to our ability to maintain and manage our
relationship with Chiesi Farmaceutici and any other collaborator,
distributor or partner; risks related to the amount and sufficiency
of our cash and cash equivalents; risks related to the ultimate
purchase by Fundação Oswaldo Cruz of alfataliglicerase pursuant to
the stated purchase intentions of the Brazilian Ministry of Health
of the stated amounts, if at all; risks related to the successful
conclusion of our negotiations with the Brazilian Ministry of
Health regarding the purchase of alfataliglicerase generally; risks
related to our commercialization efforts for alfataliglicerase in
Brazil; risks relating to the compliance by Fundação Oswaldo Cruz
with its purchase obligations and related milestones under our
supply and technology transfer agreement; risks related to the
amount and sufficiency of our cash and cash equivalents; risks
related to the amount of our future revenues, operations and
expenditures; the risk that despite the FDA’s grant of fast track
designation for pegunigalsidase alfa for the treatment of Fabry
disease, we may not experience a faster development process, review
or approval compared to applications considered for approval under
conventional FDA procedures; risks related to the FDA’s ability to
withdraw the fast track designation at any time; risks relating to
our ability to make scheduled payments of the principal of, to pay
interest on or to refinance our outstanding notes or any other
indebtedness; our dependence on performance by third party
providers of services and supplies, including without limitation,
clinical trial services; delays in our preparation and filing of
applications for regulatory approval; delays in the approval or
potential rejection of any applications we file with the FDA or
other health regulatory authorities, and other risks relating to
the review process; our ability to identify suitable product
candidates and to complete preclinical studies of such product
candidates; the inherent risks and uncertainties in developing drug
platforms and products of the type we are developing; the impact of
development of competing therapies and/or technologies by other
companies and institutions; potential product liability risks, and
risks of securing adequate levels of product liability and other
necessary insurance coverage; and other factors described in our
filings with the U.S. Securities and Exchange Commission. The
statements in this press release are valid only as of the date
hereof and we disclaim any obligation to update this information,
except as may be required by law.
Investor Contact
Marcy Nanus, Managing Director Solebury Trout 646-378-2927
mnanus@soleburytrout.com
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