CARMIEL, Israel I June 18, 2014 I Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA), announced today that the first Gaucher patient has been enrolled in the Company’s phase IIa clinical trial of oral glucocerebrosidase (GCD), or oral GCD (PRX-112), for the treatment of Gaucher disease. Oral GCD is the Company’s proprietary plant cell expressed form of an active glycosylated glucocerebrosidase enzyme (GCD) that is naturally encapsulated within carrot cells and administered orally. The Company expects the trial to be completed during the third quarter of 2014.
The phase IIa trial is a 28 day open-label, sequential dose escalation study to evaluate the safety of oral PRX-112 and study the dose dependant pharmacokinetics of Oral GCD in 10 naive adult Gaucher patients. Subjects will receive once daily oral administrations of oral GCD for five consecutive days at each dose, with a two-day washout period between doses.
In a phase I study conducted year end 2013, oral GCD was found to be safe and well tolerated in all 16 patients across all of the three doses tested. There were no drug-related serious adverse reactions reported, and no patient discontinued the study prematurely. Presence of the GCD enzyme was detected in patients’ blood circulation and the enzyme demonstrated biological activity. With a daily oral administration of oral GCD, the Company expects to achieve a steady state level of active GCD enzyme in the blood circulation of patients similar to the physiological state in healthy individuals.
“Following the completion of our phase I trial of oral GCD last year, we were encouraged to see the clinical proof of concept demonstrated in the study and we look forward to continuing the development of an oral enzyme treatment for Gaucher patients,” commented Dr. David Aviezer, Protalix’s President and Chief Executive Officer. “We believe oral delivery of GCD has the potential to improve patients’ quality of life and possibly clinical maintenance while maintaining the efficacy and safety of an enzyme treatment.”
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(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, by the Australian Therapeutic Goods Administration (TGA) in May 2014 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-112, an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel(R)) for the treatment of certain immune and inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, colitis, psoriasis and other autoimmune and inflammatory disorders; PRX-110 for the treatment of Cystic Fibrosis; and others.
SOURCE: Protalix
Post Views: 248
CARMIEL, Israel I June 18, 2014 I Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA), announced today that the first Gaucher patient has been enrolled in the Company’s phase IIa clinical trial of oral glucocerebrosidase (GCD), or oral GCD (PRX-112), for the treatment of Gaucher disease. Oral GCD is the Company’s proprietary plant cell expressed form of an active glycosylated glucocerebrosidase enzyme (GCD) that is naturally encapsulated within carrot cells and administered orally. The Company expects the trial to be completed during the third quarter of 2014.
The phase IIa trial is a 28 day open-label, sequential dose escalation study to evaluate the safety of oral PRX-112 and study the dose dependant pharmacokinetics of Oral GCD in 10 naive adult Gaucher patients. Subjects will receive once daily oral administrations of oral GCD for five consecutive days at each dose, with a two-day washout period between doses.
In a phase I study conducted year end 2013, oral GCD was found to be safe and well tolerated in all 16 patients across all of the three doses tested. There were no drug-related serious adverse reactions reported, and no patient discontinued the study prematurely. Presence of the GCD enzyme was detected in patients’ blood circulation and the enzyme demonstrated biological activity. With a daily oral administration of oral GCD, the Company expects to achieve a steady state level of active GCD enzyme in the blood circulation of patients similar to the physiological state in healthy individuals.
“Following the completion of our phase I trial of oral GCD last year, we were encouraged to see the clinical proof of concept demonstrated in the study and we look forward to continuing the development of an oral enzyme treatment for Gaucher patients,” commented Dr. David Aviezer, Protalix’s President and Chief Executive Officer. “We believe oral delivery of GCD has the potential to improve patients’ quality of life and possibly clinical maintenance while maintaining the efficacy and safety of an enzyme treatment.”
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(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, by the Australian Therapeutic Goods Administration (TGA) in May 2014 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-112, an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel(R)) for the treatment of certain immune and inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, colitis, psoriasis and other autoimmune and inflammatory disorders; PRX-110 for the treatment of Cystic Fibrosis; and others.
SOURCE: Protalix
Post Views: 248
