– 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 I June 20, 2013 I Protalix BioTherapeutics, Inc. (PLX) (PLX.TA), 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(R), 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(R), 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 website.
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(R). 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(R)) 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.
SOURCE: Protalix Biotherapeutics
Post Views: 268
– 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 I June 20, 2013 I Protalix BioTherapeutics, Inc. (PLX) (PLX.TA), 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(R), 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(R), 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 website.
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(R). 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(R)) 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.
SOURCE: Protalix Biotherapeutics
Post Views: 268
