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|Protalix BioTherapeutics to Explore Non Alcoholic Steato Hepatitis (NASH) as an Indication for Its PRX 106 Oral Anti TNF|
In preclinical studies, PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A (ConA) inflammatory mouse model. Furthermore, the drug was shown to alleviate liver damage and reducing liver necrosis and reduction of liver enzymes, ALT and AST, thus leading to an improvement in liver biopsies.
In a high fat diet model (NASH) PRX 106 demonstrated a reduction of liver enzymes, ALT and AST, reduction of serum triglycerides, along with a trend for reduction of liver fat.
The safety of orally administered PRX-106 was assessed in a 14-day repeated administration study in rats. Three doses representing up to 5x of the highest intended clinical dose were evaluated, along with a control arm. No adverse clinical symptoms presented, with all blood parameters and weight gain persistent and normal. Furthermore, there were no abnormalities in gross necropsy pathology seen in any of the animals.
In addition, a two months toxicology study to support longer duration clinical studies was successfully completed. No treatment-related adverse reactions were observed among all experimental groups.
PRX-106 has also completed a Phase I clinical trial in healthy volunteers conducted at the
"Taken together, the data from the pre-clinical and clinical studies suggest the orally administered PRX-106 is safe and can exert a profound anti-inflammatory effect in liver disorders," commented Prof.
Fatty liver disease affects 30% of the Western world population. The disease can deteriorate to its severe form, nonalcoholic steatohepatitis or NASH, which affects 2-8% of the population. NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to work properly. It can also deteriorate into primary liver cancer. NASH is becoming more common because of the greater number of people with obesity. In the past 10 years, the rate of obesity has doubled in adults and tripled in children, and is considered by many as the next global epidemic. Obesity also contributes to diabetes and high blood cholesterol, which can further complicate the health of someone with NASH.
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
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