Press Releases
View printer-friendly version |
Back |
Protalix BioTherapeutics Discloses Three New Compounds in Development
|
Jun
20
- Oral PRX-106 for immune mediated disorders
CARMIEL,
"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. 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
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
Additional information on these compounds can be found in the slides presented at the Company's Analyst Day on
About Protalix
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: 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 CONTACT: Investor Contact Marcy Nanus |