Favorable Safety and Tolerability Data Demonstrates Biological Activity in the Gut and Activation of Regulatory T Cells
CARMIEL, Israel I August 3, 2015 I Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA), announced today positive clinical study results from the Company’s Phase I trial of PRX-106, an orally administered plant cell-expressed recombinant anti-TNF fusion protein. PRX-106 demonstrated a favorable safety and tolerability profile and biological activity in the gut.
The Phase I trial is a randomized, parallel-design, open-label study designed to evaluate the safety and pharmacokinetics of PRX-106 in healthy volunteers. The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days.
The results demonstrated that oral administration of PRX-106 is safe and well tolerated. No major side effects were noted, and no suppression of the immune system was observed. Regulatory T cell activation showing biological activity in the gut was observed. Fluorescence-activated cell sorting analysis (FACS) was performed using various antibodies for surface markers, and it was observed that all three dosages of PRX-106 promoted the induction of various subsets of T cells, some of which are correlated with anti-inflammatory response.
“The results demonstrated in the Phase I trial are very exciting and encouraging. As T regulatory cells have a central role in the immune system, PRX-106 has the potential to be an effective agent for numerous immune-mediated indications,” said Prof. Yaron Ilan of the Gastroenterology and Liver Units, Director of the Department of Medicine of the Hebrew University-Hadassah Medical Center in Jerusalem.
In preclinical studies evaluating oral PRX-106 the compound alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A immune mediated hepatitis mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis in a well-established mouse model, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells.
Protalix is currently evaluating the best indication to take forward with PRX-106. The Company anticipates identifying this shortly and initiating a proof of concept trial in patients around year end.
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, subsequently by Israel’s Ministry of Health, by the Brazilian National Health Surveillance Agency (ANVISA) 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 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-106, an orally-delivered anti TNF; PRX-110 for the treatment of Cystic Fibrosis; and others.
SOURCE: Protalix BioTherapeutics
Post Views: 186
Favorable Safety and Tolerability Data Demonstrates Biological Activity in the Gut and Activation of Regulatory T Cells
CARMIEL, Israel I August 3, 2015 I Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA), announced today positive clinical study results from the Company’s Phase I trial of PRX-106, an orally administered plant cell-expressed recombinant anti-TNF fusion protein. PRX-106 demonstrated a favorable safety and tolerability profile and biological activity in the gut.
The Phase I trial is a randomized, parallel-design, open-label study designed to evaluate the safety and pharmacokinetics of PRX-106 in healthy volunteers. The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days.
The results demonstrated that oral administration of PRX-106 is safe and well tolerated. No major side effects were noted, and no suppression of the immune system was observed. Regulatory T cell activation showing biological activity in the gut was observed. Fluorescence-activated cell sorting analysis (FACS) was performed using various antibodies for surface markers, and it was observed that all three dosages of PRX-106 promoted the induction of various subsets of T cells, some of which are correlated with anti-inflammatory response.
“The results demonstrated in the Phase I trial are very exciting and encouraging. As T regulatory cells have a central role in the immune system, PRX-106 has the potential to be an effective agent for numerous immune-mediated indications,” said Prof. Yaron Ilan of the Gastroenterology and Liver Units, Director of the Department of Medicine of the Hebrew University-Hadassah Medical Center in Jerusalem.
In preclinical studies evaluating oral PRX-106 the compound alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A immune mediated hepatitis mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis in a well-established mouse model, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells.
Protalix is currently evaluating the best indication to take forward with PRX-106. The Company anticipates identifying this shortly and initiating a proof of concept trial in patients around year end.
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, subsequently by Israel’s Ministry of Health, by the Brazilian National Health Surveillance Agency (ANVISA) 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 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-106, an orally-delivered anti TNF; PRX-110 for the treatment of Cystic Fibrosis; and others.
SOURCE: Protalix BioTherapeutics
Post Views: 186
