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Protalix BioTherapeutics Announces First Patient Treated in Phase I/II Study of Fabry Patients With PRX-102



Protalix BioTherapeutics Announces First Patient Treated in Phase I/II Study
of Fabry Patients With PRX-102

CARMIEL, Israel, Dec. 10, 2012 (GLOBE NEWSWIRE) -- 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.  ELELYSO^TM, 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
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