Archive for May 7th, 2012

Protalix Soars on FDA Approval of Gaucher Drug: Tel Aviv Mover

7 May, 2012

See on Scoop.itVirology News

“Protalix BioTherapeutics Inc. soared in Tel Aviv trading after the biopharmaceutical company’s first product won approval from the U.S. Food and Drug Administration.

Protalix expects approval to sell its Gaucher disease drug in Israel soon, Aviezer said. Israel has at least 500 patients affected with the illness, he said. The company also is awaiting a regulatory decision in the European Union.
“This is a biotechnology milestone as it it the first time the FDA has approved a product that was engineered in plant cells, as opposed to mammalian or bacterial-based systems,” Yoav Kedar, a biotechnology consultant for Clal Finance Brokerage Ltd., said in an interview. “The approval will better position the company to receive approvals in Europe, Israel and Brazil.”
Gaucher disease can cause fat to build up in the liver, spleen, bone marrow and nervous system. About 1 in 14 individuals of Ashkenazi Jewish ancestry carries the mutated gene that can cause the illness, and as many as 1 in 500 present a form of the disorder.”

 

This is a seriously big deal, and I have blogged on it here before: this is a plant-made bio-better, now licenced for human use as a therapeutic ofr a nasty genetic disease.  It should compete well, given that other offerings are made in mammalian cells – and one manufacturer’s output was recently shut down completely due to a viral infection of their cell cultures, which is what led to accelerated approval for Protalix’s product.

 

Going green…you know the rest.

See on www.bloomberg.com

Landes Bioscience Journals: Human Vaccines & Immunotherapeutics

7 May, 2012

See on Scoop.itVirology News

Rapid production of influenza vaccine antigen is an important challenge when a new pandemic occurs. Production of recombinant antigens in plants is a quick, cost effective and up scalable new strategy for influenza vaccine production.  In this study, we have characterized a recombinant influenza haemagglutinin antigen (HAC1) that was derived from the 2009 pandemic H1N1 virus and expressed in tobacco plants. Volunteers vaccinated with the 2009 pH1N1 oil-in-water adjuvanted vaccine provided serum and lymphocyte samples that were used to study the immunogenic properties of the HAC1 antigen in vitro. By 7 d post vaccination, the vaccine fulfilled the licensing criteria for antibody responses to the HA detected by haemagglutination inhibition and single radial hemolysis. By ELISA and ELISPOT analysis we showed that HAC1 was recognized by specific serum antibodies and antibody secreting cells, respectively. We conducted a kinetic analysis and found a peak of serum HAC1 spec antibody response between day 14 and 21 post vaccination by ELISA. We also detected elevated production of IL-2 and IFNγ and low frequencies of CD4+ T cells producing single or multiple Th1 cytokines after stimulating PBMCs (peripheral blood mononuclear cells) with the HAC1 antigen in vitro. This indicates that the antigen can interact with T cells, although confirming an effective adjuvant would be required to improve the T-cell stimulation of plant based vaccines. We conclude that the tobacco derived recombinant HAC1 antigen is a promising vaccine candidate recognized by both B- and T cells.

 

Fraunhofer USA, waving the Green Vaccine flag: way to go….

See on www.landesbioscience.com