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Here's A Look At The Latest Protalix Biotherapeutics Inc (NYSEMKT:PLX) Data

Here's A Look At The Latest Protalix Biotherapeutics Inc (NYSEMKT:PLX) Data
Written by
Chris Sandburg
Published on
April 19, 2017
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We looked at Protalix Biotherapeutics Inc (NYSEMKT:PLX) last week as part of this piece, when the company took a hit on some misinformation regarding a data drop. That situation is behind us now, and we're not going to bring it up again. What we are going to do, however, is revisit the company from a different perspective, as brought about by the release of preclinical data from one of its secondary (but very much valid from an investment thesis standpoint) programs.The company put out the news mid market on Tuesday, and as things stand, is running pretty flat on the back of the release. There's value in it, however, and we suspect that the unwillingness to pull the trigger on a position by operators that might otherwise be jumping in head first is rooted in the above mentioned misinformation.Anyway, let's look at the latest release in an attempt to decipher what it means, and what it's implications are for Protalix longer term.It's a preclinical data release, as mentioned, and it refers to a drug called PRX-102. Protalix is investigating the drug as a potential treatment for a condition called Fabry disease, which for those not familiar with the indication, is a progressive genetic condition that causes health things like extreme tiredness, little to no sweating, a reddish-purplish skin rash called angiokeratoma, burning pain in the hands and feet, problems in the heat and cold and frequent diarrhea and constipation. Longer term, it can result in heart and kidney disease, or at least earlier progression of these disease types in patients that might otherwise have been predisposed to them. The condition is rooted a lack of an enzyme called alpha-GAL, which comes about as the result of mutations in the gene that's responsible for the creation of this enzyme – a gene called GLA. A lack of alpha-GAL causes buildup of the fatty substance it would normally responsible for breaking down (called GL-3) and this buildup causes the symptoms of the condition.PRX-102 is a modified version of the GAL protein – its MOA is relatively self explanatory.That's the science.The current SOC in the space is something called Replagal, and PRX-102 is essentially a version of Replagal that's been made with plant cells instead of mammalian cells. The theory is that this is not only a cheaper way to produce the same drug, but that it could also lead to an improved efficacy and safety profile (based on the fact that it's a more stable construction).So, the data just released came fro a study that, naturally, was set up to compare PRX-102 to Replagal and another SOC called Fabrazyme. It was a mouse study, with three active arms – one 102, one Replagal and one Fabrazyme.As per the latest release, mice (with Fabry disease) treated with PRX-102 showed a 53% reduction in the number of what are called Iba1 spots (these are used as a marker for inflammation, and a signal of Fabry severity), compared to untreated Fabry controls. Further, and just as importantly, Iba1 levels in the PRX-102 arm reached the levels of the healthy mice, while there was no difference in the Iba1 marker in Fabry mice treated with Replagal or Fabrazyme compared to untreated Fabry mice.So what's next?Well, this data serves as strong proof of concept, and should validate an advance from the lab to the clinic for Protalix and its PRX-102 asset in this patient population. Against a backdrop of the cystic fibrosis situation (again, we're not going to get drawn into that debate here), that's a bit of good news that should serve to ease sentiment somewhat at a time that a sentiment lift is very much needed.Keep an eye on said advancing as the next PRX-102-related catalyst, and keep in mind that there's a little bit of added dilutive risk on said advance ahead of picking up an exposure.We will be updating our subscribers as soon as we know more. For the latest updates on PLX, sign up below!Disclosure: We have no position in PLX and have not been compensated for this article.

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