PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Yes this indeed very good news. Hi John, I can see where potential confusion might come from on this, so please allow me to explain.

In the simplest terms, this statement reflects the benefit we are seeing from the patients is directly related to the activity of PRX-110 (Alidornase alpha). And that the activity is more potent than that of the current Pulmozyme treatment (Dornase alpha).

Also just for your understanding of the following data explanation, ppFEV1, means, percent predicted forced expiratory volume in one second. This is the key measure to use for these patients as it indicates their lung function. A higher ppFEV1 indicate better lung function and reduced viscosity of sputum in the airways.

Now referring to the data that your highlighted statement refers to, please see the Bar chart in the news article:
http://www.nasdaq.com/press-release/protalix-biotherapeutics-announces-phase-ii-clinical-trial-results-for-alidornase-alfa-in-cystic-20170607-00314#ixzz4jQAZjptT


We can see this beneficial effect is due to PRX-110 activity and better than Pulmozyme, as when patients are taken off Pulmozyme, the patients only saw a negligable decrease in the performance of their ppFEV1 (-0.06). This decrease is small because effectively the Pulmozyme treatment was providing little benefit over baseline (no treatment). So when we take the patients off Pulmozyme, we don't see a big drop in lung performance, as Pulmozyme (Dornase) was not really benefiting them very much.

However first off we see that Alidornase (PRX-110) vs Dornase (Pulmozyme), that PRX-110 shows a full 3.3 point increase in ppFEV1 better than Dornase, which already evidences PRX-110 better therapeutic benefit. And then to further evidence that the benefit is directly due to PRX-110 is that when the patients are taken off PRX-110, there is a very significant decrease in the patients lung function (-2.7). The reason why we see the 'bigger drop' is because once the treatment is over the patients are dropping back to their normal baseline, and that the perceived drop is bigger because the clinical efficacy of PRX-110 is stronger than that of Pulmozyme.

Very good news indeed.

Also the additional information is great too:

In the same news article we see two line graphs. Both of these show the same ppFEV1 data (the blue lines), but with different simultaneous data, Mean Stress and Mean DNA content, respectively.

The 1st graphs compares the Mean Stress or really the effort the patient is needing to place on his/her lungs/airways to achieve the corresponding ppFEV1 scores. As you can see with the -14day to 1day data (this was when the patient was on their last day of Pulmozyme treatment '-14d' and then the 14 day washout period before starting PRX-110 treatment on 1day), we can see that from the last day of taking Pulmozyme and the following 2 week washout, there is almost no difference in ppFEV1, showing that Pulmozyme again was providing very little benefit. Also you can see the mean stress over that time period remains high, again showing the little benefit from Pulmozyme.
In comparison, you can see that from 1day (beginning PRX-110 treatment) both the ppFEV1 scores immediately increases, and the mean stress needed to achieve the ppFEV1 score goes down significantly, showing that PRX-110 is showing truly fantastic benefit in prolonged activity of reducing sputum viscosity. After the 14 day PRX-110 treatment duration and the patients are taken off PRX-110, we then see the scores of ppFEV1 go back down and mean stress go back up, again evidencing the benefit is only seen during PRX-110 activity.

And the 2nd graph: As mentioned the ppFEV1 line is the same, but here we are looking at the mean DNA content in the sputum (which makes up a large part of what's making the sputum viscous and hard to breath through), the DNA content is relatively unchanged from last Pulmozyme day use and the end of the washout period, but when beginning PRX-110 treatment, then DNA content (and this viscosity) is significantly reduced. Then, once again we see that once the PRX-110 treatment is over the DNA levels climb back up, showing the efficacy is related to PRX-110 use.

And finally, in the text of the article it is stated, more great data is that "In addition, analysis of the presence of pseudomonas aeruginosa in patients available sputum samples was evaluated using qPCR. The analysis demonstrated a reduction of over 70%, compared to baseline, in the presence of pseudomonas as a result of alidornase alfa treatment.".
This is important as due to the higher viscosity of mucus and sputum in CF patients, they are susceptible to frequent lung infections. So here we a seeing a correlation of the prolonged benefit of PRX-110, which is to significantly reduce the space where the bacteria collect and so we are finding very significantly less of the bacterial DNA.

Remember the key reason for all of PRX-110's benefits is that it last far longer than Pulmozyme, as PRX-110 is resistant to inhibition by Actin, whereas Pulmozyme is not and is therefore quickly and significantly degraded.

All the best,
Spidey