Protalix (PLX)

[takochan1]

why is it going down? I didn't see any bad news or anything, I guess investors just cashing in? seems like good time to buy, they are suppose to release the trial iii result in 4th quarter, any thoughts?

[am_wood]

ditto, I'm long on this one. Should I buy, sell, or hold?

[alex1111]

Is your trade based on technicals or fundamentals or a mixture? I'm a technical trend trader, and I can't draw a trendline in any timeframe.

[newguy]

I have just submitted this information to the calendar:

Already in use pre-approval under a special clearance because of production problems at GENZ that caused severe shortage of treatment for people suffering from Gaucher's desease.

Partnership with PFE.

New revolutionary platform and technology - plant-cell-expressed recombinant form of proteins, effectively growing drugs in carrots.

By using a different expression form of the same molecule, PLX may legally produce the equivalent of any patent-protected drug without actually breaching the patent - no drug may be protected against this platform.

The GENZ production blunders may not be repeated here: plant viruses are not transmittable to humans, so this is the only source for drugs that are 100% free of human viruses. (Also, this is a much cheaper way than mammalian cells to grow those proteins.)

The company:

Located in Carmiel, Israel.

Competitors (treatment for Gaucher's disease): GENZ (U.S.), Shire (U.K.).

Pipeline: more drugs under development using the same platform.

Possible U.S. DoD contract in the future for a new nerve-gas treatment. Only Phase-I study will be needed, as it is impossible to conduct Phase-II and III studies for nerve gas.

[newguy]

This one could land Protalix a U.S. DoD contract:

Protalix BioTherapeutics Completes Phase I Clinical Trial for PRX-105 -- CARMIEL, Israel, June 8 /PRNewswire-FirstCall/ --

Protalix BioTherapeutics Completes Phase I Clinical Trial for PRX-105

CARMIEL, Israel, June 8 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX) announced today the completion of its phase I clinical trial of PRX-105, a plant cell expressed pegylated recombinant human acetylcholinesterase in development for biodefense indications. The trial established the pharmacokinetics of the protein and demonstrated that single dose, intravenous administration of PRX-105 is safe and well tolerated.

"We are very pleased with the favorable safety and pharmacokinetic results from our phase I clinical trial of PRX-105," said Dr. David Aviezer, Protalix's President and Chief Executive Officer. "The positive results also provide further validation of the safety and breadth of our ProCellEx™ plant cell based expression system."

The Company plans to perform additional safety studies in healthy volunteers and animals in collaboration with civil and military agencies in the United States and Israel, for which discussions have been initiated. Given the nature of the biodefense indications for which the Company is developing PRX-105, efficacy trials of PRX-105 in humans (phase II and phase III) are not required.

The phase I clinical trial of PRX-105 is a first in human, open label, non-randomized, single-dose study. PRX-105 is administered intravenously by slow bolus injection to 10 healthy volunteers in the trial. The trial is being conducted in collaboration with Professor Hermona Soreq, from the Hebrew University in Jerusalem, Israel, a world leader in the field of acetylcholinesterase research. The production of PRX-105 is based on patents that were licensed to Protalix Ltd. by Yissum, the Technology Transfer Company of the Hebrew University, Jerusalem.

Pre-clinical studies have indicated that PRX-105 successfully protects animals exposed to organophosphate nerve gas agent analogs, in both the prophylactic and post-exposure settings.

About Protalix

Protalix is a biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based expression system. Protalix's ProCellEx™ presents a proprietary method for the expression of recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale production of recombinant therapeutic proteins in an environment free of mammalian components and viruses. Protalix is also advancing additional recombinant biopharmaceutical drug development programs. Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol Assessment with the FDA for Gaucher disease. In August 2009, the FDA granted orphan drug status and fast track designation to taliglucerase alfa for the treatment of Gaucher disease and Protalix filed a rolling NDA submission with the FDA in December 2009. In November 2009, Protalix granted Pfizer Inc. exclusive, worldwide rights to develop and commercialize taliglucerase alfa for the treatment of Gaucher disease, except in Israel. Protalix retained the right to commercialize taliglucerase alfa in Israel.