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Protalix BioTherapeutics Discloses Three New Compounds in Development

Published: Monday, June 24, 2013
Last Updated: Monday, June 24, 2013
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New biologics announced for treatment of immune mediated discorder, Cystic Fibrosis and emphysema.

Protalix BioTherapeutics, Inc. 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.


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