Full Press Release Details
Protalix BioTherapeutics Discloses Three
New Compounds in Development
- Oral PRX-106 for immune mediated disorders
- PRX-110 for Cystic Fibrosis (CF)
- PRX-107 for emphysema due to hereditary alpha1-antitrypsin deficiency
CARMIEL, Israel, June 20, 2013 /GlobeNewswire /Protalix BioTherapeutics,
Inc. (NYSE-MKT:PLX, TASE:PLX), today held an Analyst Event in which included the disclosure of new data regarding three new compounds
in development, oral PRX-106 for immune mediated disorders, PRX-110 for Cystic Fibrosis (CF), and PRX-107 for emphysema from heredity
alpha1-antitrypsin (AAT) deficiency.
"Our validated plant-cell based platform, ProCellEx ,
has the capacity to generate a diverse array of protein therapeutics, each with highly unique characteristics. With this next wave
of compounds and oral administration modalities, we are building a strong pipeline and potentially treatment advances to patients,"
said Dr. David Aviezer, Protalix BioTherapeutics' President and Chief Executive Officer.
PRX-106 is the Company's proprietary plant cell recombinant
Anti-TNF fusion protein being developed as an orally-administered treatment for immune mediated disorders. In preclinical studies,
oral PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A (ConA) mouse model. Additionally,
oral administration of PRX-106 alleviated immune mediated colitis, a well established model for Crohn's disease, promoting
serum levels of anti-inflammatory IL-10 and regulatory T-cells. The Company is conducting additional preclinical studies for oral
PRX-106 in additional attractive indications.
PRX-110 is the Company's proprietary plant cell recombinant
human Deoxyribonuclease 1 (DNase 1) under development for the treatment of CF, to be administered by inhalation. PRX-110 works
by cleaving extracellular DNA and thinning the thick mucus that accumulates in CF patients' lungs. In preclinical trials,
PRX-110 demonstrated improved enzyme kinetics, less sensitivity to inhibition by actin and improved ex-vivo efficacy when compared
to Pulmozyme , the only approved form of recombinant DNase 1 manufactured in Chinese hamster ovary (CHO) cells. The Company
held a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) in 2012, and plans to file an
IND with the FDA following the completion of toxicology studies, which is expected to occur by year end.
PRX-107 is the Company's proprietary plant cell recombinant
human Alpha1-antitrypsin (AAT) under development for the treatment of emphysema due to hereditary AAT deficiency, to be administered
by inhalation. PRX-107 is a protein that works by regulating the AAT-dependent inflammatory response in the lungs. Currently, there
is no approved recombinant form of AAT. Plasma derived-forms of AAT are available, but are associated with limitations, including
inadequate supply, the potential for adventitious agents and poor absorption. In preclinical studies, PRX-107 demonstrated the
ability to rescue elastase induced lung damage in rats and as effective as a plasma-derived reagent. The Company plans to hold
a pre-IND meeting with the FDA in the second half of 2013 to discuss next steps for this compound.
Additional information on these compounds can be found in the
slides presented at the Company's Analyst Day on June 20, 2013. These are available under the presentation tab on the Company's
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, by Israel's Ministry of Health in September 2012,
by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection
against Sanitary Risk (COFEPRIS) in April 2013, and by the regulatory authorities of other countries. Marketing applications for
taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide
development and commercialization of taliglucerase alfa, excluding Israel and Brazil, where Protalix retains full rights. 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 produced and encapsulated within 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; PRX-110 for the treatment of Cystic
Fibrosis; PRX-107 for the treatment of emphysema due to hereditary alpha1-antitrypsin deficiency; 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 preclinical studies and 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 trials will not support the applicable
claims of safety or efficacy, that our product candidates 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 FDA, 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; risks related to the potential
infringement of a third party's patents or other intellectual property rights; the uncertainty of obtaining patents covering
our products and processes and in successfully enforcing our intellectual property rights against third parties; 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.
The Trout Group, LLC
MacDougall Biomedical Communications
Source: Protalix BioTherapeutics, Inc.