Protalix BioTherapeutics Announces First Patient Treated in Phase I/II Study of Fabry Patients With PRX-102
10 Dezember 2012 - 8:00AM
Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced
today that the first patient has been treated in the Company's
phase I/II clinical trial of Fabry patients with PRX-102. PRX-102
is the Company's proprietary plant cell-expressed, chemically
modified recombinant alpha-galactosidase-A enzyme in development as
a long-term enzyme replacement therapy (ERT) for the treatment of
Fabry disease.
"We are pleased to have PRX-102 enter the clinic this year as
planned. We believe PRX-102 may eventually serve as an
alternative treatment for Fabry patients with the potential to be
an improved enzyme replacement therapy," said Dr. Einat Brill
Almon, the Company's Senior Vice President, Product
Development. "PRX-102 is manufactured using ProCellEx®, our
proprietary recombinant protein expression system which uses
genetically engineered plant cells to produce specific protein
products. ELELYSOTM, our first commercial product which was
approved by the U.S. Food and Drug Administration in May 2012, is
also manufactured through ProCellEx."
The phase I/II clinical trial is a worldwide, multi-center, open
label, dose ranging study to evaluate the safety, tolerability,
pharmacokinetics and exploratory efficacy parameters of PRX-102 in
adult Fabry patients. The trial is designed to enroll 18
adult Fabry patients, each in one of three dosing groups. Each
patient will receive intravenous infusions of PRX-102 every two
weeks for 12 weeks. After the completion of the protocol, the
Company intends to offer enrolled trial patients the option to
continue to receive PRX-102 in an open-label extension study.
About Protalix
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,
ELELYSO™ (taliglucerase alfa), was approved for marketing by the
U.S. Food and Drug Administration on May 1, 2012 and by Israel's
Ministry of Health in September 2012. Protalix has partnered
with Pfizer Inc. for the worldwide development and
commercialization of ELELYSO™, excluding Israel, where Protalix
retains full rights. Marketing applications for taliglucerase
alfa have been filed in additional territories as
well. Protalix's development pipeline also includes the
following product candidates: PRX-102, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry
disease; PRX-105, a pegylated recombinant human
acetylcholinesterase in development for several therapeutic and
prophylactic indications, a biodefense program and an
organophosphate-based pesticide treatment program; an
orally-delivered glucocerebrosidase enzyme that is naturally
encased in carrot cells, also for the treatment of Gaucher disease;
pr-antiTNF, a similar plant cell version of etanercept (Enbrel®)
for the treatment of certain immune diseases such as rheumatoid
arthritis, juvenile idiopathic arthritis, ankylosing spondylitis,
psoriatic arthritis and plaque psoriasis; and others.
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
"anticipate," "believe," "estimate," "expect," "plan" 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. Factors that might cause material differences
include, among others: failure or delay in the commencement or
completion of our clinical trials which may be caused by several
factors, including: unforeseen safety issues; determination of
dosing issues; lack of effectiveness during clinical trials; slower
than expected rates of patient recruitment; 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 the clinical trials; the risk that the results
of our clinical trial of PRX-102 will not support our claims of
safety or efficacy, that PRX-102 will not have the desired effects
or includes undesirable side effects or other unexpected
characteristics; 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 U.S. Food
and Drug Administration, or other health regulatory authorities;
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 clinical
trial insurance coverage; and other factors described in our
filings with the U.S. Securities and Exchange Commission. The
statements in this release are valid only as of the date hereof and
we disclaim any obligation to update this information.
CONTACT: Investor Contact
Tricia Swanson
The Trout Group, LLC
646-378-2953
tswanson@troutgroup.com
Media Contact
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com