Protalix Announces Presentation of Phase III Taliglucerase Alfa Data at WORLD Lysosomal Disease Network
2010年2月4日 - 9:30PM
PRニュース・ワイアー (英語)
CARMIEL, Israel, Feb. 4 /PRNewswire-FirstCall/ -- Protalix
Biotherapeutics, Inc. (NYSE- Amex: PLX) today announced that data
from its pivotal Phase III trial of taliglucerase alfa in patients
with Gaucher disease will be presented at the Annual Meeting of the
Lysosomal Disease Network: WORLD Symposium 2010, February 10-12,
2010 in Miami, Florida. Hanna Rosenbaum, M.D., Director of
Hematology Day Care Unit, RAMBAM Medical Center, Haifa, Israel and
study investigator, will give the oral presentation, titled: "Novel
Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal
Clinical Trial with Plant Cell Expressed Recombinant
Glucocerebrosidase (prGCD) - taliglucerase alfa," on Thursday,
February 11, 2010 at 10:15 AM ET. The symposium is co-organized by
the Lysosomal Disease Network and the National Institutes of
Health. Participants include clinicians, geneticists, neurologists
and other health care professionals. About Gaucher disease Gaucher
disease, an inherited condition, is the most prevalent lysosomal
storage disorder, with an incidence of about 1 in 20,000 live
births. People with Gaucher disease do not have enough of an
enzyme, beta-glucosidase (glucocerebrosidase) that breaks down a
certain type of fat molecule. As a result, lipid engorged cells
(called Gaucher cells) amass in different parts of the body,
primarily the spleen, liver and bone marrow. Accumulation of
Gaucher cells may cause spleen and liver enlargement, anemia,
excessive bleeding and bruising, bone disease and a number of other
signs and symptoms. About Protalix Protalix is a biopharmaceutical
company focused on the development and commercialization of
proprietary recombinant therapeutic proteins expressed through its
proprietary plant cell based expression system. Protalix's
ProCellEx(TM) presents a proprietary method for the expression of
recombinant proteins that Protalix believes will allow for the
cost-effective, industrial-scale production of recombinant
therapeutic proteins in an environment free of mammalian components
and viruses. Protalix is also advancing additional recombinant
biopharmaceutical drug development programs. Taliglucerase alfa is
an enzyme replacement therapy in development under a Special
Protocol Assessment with the FDA for Gaucher disease. 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 material differences include, among
others, risks relating to: the successful preclinical development
of our product candidates; the completion of clinical trials; the
review process of the FDA, the EMEA, other foreign regulatory
bodies and other governmental regulatory bodies, including the
FDA's and the EMEA's review of any filings we make in connection
with the treatment protocol; delays in the FDA's, the EMEA's or
other health regulatory authorities' approval of any applications
we file or refusals to approve such filings; refusals by such
regulatory authorities to approve the marketing and sale of a drug
product even after acceptance of an application we file for any
such drug product; the identification of lead compounds; the risk
that we may fail to satisfy certain conditions relating to grants
we have received from the Office of the Chief Scientist of Israel's
Ministry of Industry and Trade which may lead to our being required
to refund grants previously received together with interest and
penalties; the risk that the Office of the Chief Scientist may not
deliver to us all of the funds awarded to us; uncertainties related
to the ability to attract and retain partners for our technologies
and products under development; and other factors described in our
filings with the Securities and Exchange Commission. Companies in
the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced or late-stage clinical trials,
even after obtaining promising earlier trial results or in
preliminary findings for such clinical trials. Further, even if
favorable testing data is generated by clinical trials of drug
products, the FDA, EMEA or any other foreign regulatory authority
may not accept or approve an NDA filed by a pharmaceutical or
biotechnology company for such drug product. Failure to obtain
approval from the FDA, EMEA or any other foreign regulatory
authority of any of our drug candidates in a timely manner, if at
all, will severely undermine our business and results of operation
by reducing our potential marketable products and our ability to
generate corresponding product revenues. The statements in this
release are valid only as of the date hereof and we disclaim any
obligation to update this information. Investor Contact: Marcy
Nanus The Trout Group, LLC Telephone: 646-378-2927 Email: Media
Contact: Brad Miles BMC Communications Group, LLC Telephone:
212-477-9007 x17 Email: DATASOURCE: Protalix Biotherapeutics, Inc.
CONTACT: Investor Contact, Marcy Nanus, The Trout Group, LLC,
+1-646-378-2927, ; or Media Contact, Brad Miles, BMC Communications
Group, LLC, +1-212-477-9007 x17, , all for Protalix
Biotherapeutics, Inc.
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