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News from Redorbit Apr.18, 2007
Protalix BioTherapeutics, Inc.
Receives Approval From the FDA to Initiate a Phase III Clinical
Trial of prGCD
CARMIEL, Israel, April 18 /PRNewswire-FirstCall/ --
Protalix
BioTherapeutics, Inc. today announced that it has received
written notice from the United States Food and Drug Administration
(FDA) that it may initiate a Phase III clinical trial in the United
States of its lead product candidate, prGCD, a proprietary plant
cell expressed recombinant form of human Glucocerebrosidase (GCD),
for the treatment of
Gaucher Disease, a lysosomal storage disorder in humans.
The FDA has allowed the Company to directly initiate Phase III based
upon the results of the Company's pre clinical and Phase I clinical
trials of prGCD. The Company presented the completed data from its
Phase I clinical trial at the European Working Group of Gaucher
Disease (WEGGD) in Cambridge, United Kingdom in July 2006.
The Company hopes to commence the Phase III clinical trial shortly.
The trial will take place in centers in the United States, Israel,
where approval from the Israeli Ministry of Health has been received,
and other locations worldwide. The study will initially consist of
male and female adult patients with Gaucher Disease.
David Aviezer, Ph.D., President and Chief Executive Officer of
Protalix BioTherapeutics, commented, "The receipt of the FDA's
approval to initiate a Phase III clinical trial of prGCD represents
an important milestone in the development of this product, and we
are excited about the progress we have made thus far. Following the
success of our Phase I trial and our promising pre clinical and
biochemical data, we believe that we will continue to see positive
results from our patients in Phase III."
Dr. Aviezer continued, "We remain deeply committed to the
development of a treatment for Gaucher Disease and are excited by
the opportunity to commence the Phase III trial and working with the
medical experts and patient community."
About Protalix BioTherapeutics, Inc.
Protalix's proprietary technology is based on its plant cell culture
and bioreactor system, which provides an effective and scaleable
cell system for industrial production of recombinant
biopharmaceuticals. Protalix is pursuing advanced clinical studies
for its enzyme therapy for Gaucher Disease and intends to advance
additional recombinant biopharmaceutical drug development programs.
The Company believes its plant-based expression has significant
advantages over more traditional mammalian and bacterial expression
technology with respect to patient safety, cost and scalability.
Safe Harbor Statement
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. 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
such a material difference include, among others, the inherent risks
and uncertainties in developing drug platforms and products of the
type we are developing; 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; lack of progress of our
research and development (including the results of clinical trials
being conducted by us); obtaining on a timely basis sufficient
patient enrollment in our clinical trials; the impact of development
of competing therapies and/or technologies by other companies; our
ability to obtain additional financings required to fund our
research programs; our ability to establish and maintain strategic
license, collaboration and distribution arrangements and to manage
our relationships with collaborators, distributors and partners;
potential product liability risks and risks of securing adequate
levels of product liability and clinical trial insurance coverage;
the possible disruption of our operations due to terrorist
activities and armed conflict, including as a result of the
disruption of our subsidiary, our manufacturing facilities,
collaborative partners, licensees, and clinical trial sites; and
other factors described in our filings with the Securities and
Exchange Commission. The statements are accurate only as of the date
hereof and we disclaim any obligation to update this information,
except as required by law.
Protalix BioTherapeutics, Inc.
CONTACT: Protalix Investor Relations:
investors@protalix.com
,+972-4-988-9488; AMEX IR Alliance for Protalix: Lee Roth,
+1-212-896-1209,lroth@kcsa.com , or David Burke,
+1-212-896-1258, dburke@kcsa.com
Source: PRNewswire-FirstCall
http://www.redorbit.com/news/health/906250/protalix_biotherapeutics_inc_receives_approval_from_t
he_fda_to_initiate/index.html?source=r_health
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