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|Protalix BioTherapeutics Announces New Strategy for Accelerated Growth|
PRX-102 for Fabry disease
PRX-102 is designed to be an improved enzyme replacement therapy product for Fabry disease given its potential for clinically superior outcomes and enhanced safety when compared to currently marketed enzyme replacement therapies. The product remains a key focus for the Company and will aggressively be pushed through clinical development. Interim efficacy and safety data from the Company's ongoing Phase I/II trial will be presented during Protalix's corporate presentation at the
Oral Anti-TNF (PRX-106) for Inflammatory Bowel Disease
Oral Anti-TNF represents a novel mode of administering a recombinant anti-TNF protein. The Company plans to initiate clinical efficacy trials of Oral Anti-TNF for the treatment of Inflammatory Bowel Disease (IBD) in a non-IND setting during 2015. Upon reviewing the proof of concept (POC) data, expected in early 2016, the Company intends to collaborate with a well-suited partner for further development.
AIR DNase (PRX-110) for Cystic Fibrosis
AIR DNase has an actin inhibition resistance that is designed to improve lung function and lower the incidence of recurrent infections by enhancing the enzyme's efficacy in patients sputa. The product has demonstrated improved disease parameters in animal models and human sputum testing when compared to the currently marketed product. The Company plans to initiate clinical efficacy trials of AIR DNase for the treatment of Cystic Fibrosis (CF) in a non-IND setting during 2015. Upon reviewing the results of the trial, expected in early 2016, the Company intends to collaborate with a well-suited partner for further development.
Oral GCD (PRX-112) for Gaucher Disease
Oral GCD represents a novel mode of administrating taliglucerase alfa, the Company's approved enzyme replacement therapy for Gaucher disease. The initial clinical data generated for this compound in pre-clinical and Phase I trials is promising. In 2015, Protalix will focus on improving the drug's formulation and delivery in order to transform it into a commercially viable product.
Potential Pipeline Candidates
Protalix aims to expand the Company's pipeline by leveraging the advantages of the ProCellEx® proprietary protein expression technology. The focus will be on biologics with improved clinical profiles than the currently marketed proteins for these indications. Biosimilars will not be a focus for the Company, and will only be considered in the case of proteins that are highly difficult to express or that represent opportunities for early market entry arising from Protalix' plant cell based intellectual property advantages.
Elelyso™ for Gaucher Disease
The Company anticipates continuing to increase market share in
"We are very excited with our new path forward as there are a number of key value creating milestones that have the potential to significantly increase shareholder value," commented Mr.
- Report interim efficacy and safety results from Phase I/II trial of PRX-102 in early
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
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: risks related to management transitions; risks related to the commercialization of our drug product; failure or delay in the commencement or completion of our preclinical 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 clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with 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
CONTACT: Investor Contact Marcy Nanus