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Drano

05/16/15 9:33 AM

#102618 RE: To infinity and beyond! #102607

Somewhere in the vast sea of data, press releases, and presentations at conferences, the blood pressure issue was specifically mentioned as a transient and manageable event. The PolyMedix data is meaningless because the doses were vastly higher and more frequent than the seemingly effective much lower dosages they are testing.

Any medication taken to excess can cause a significant adverse effect -- for instance, digitalis has been used safely since the 18th century for cardiac conditions -- but take too much, and you are on the autopsy table. Take a few Tylenol for a headache and it will help, take too many and you need a liver transplant, if you survive the overdose.

The potential transient spike in blood pressure is far less risky than the risks that many commonly used antibiotics have. Permanent deafness, spontaneous tendon rupturing, diarrhea, disorientation, and many more side effects have been well documented for Cipro, yet it continues to be commonly prescribed -- as my colleague tragically discovered, a previously healthy and active 50 year old who is now wheelchair-bound for the rest of his life because of a reaction to it. Compared to that, I think his doctors would have greatly preferred managing a one-day or less spike in blood pressure, and perhaps temporary numbness and tingling in his limbs (IF in the worst-case scenario he had those side effects).

Let me say it again: THE POLYMEDIX DATA IS MEANINGLESS BECAUSE IT WAS FROM VASTLY HIGHER AND MORE FREQUENT TREATMENT REGIMENS.
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MinnieM

05/16/15 2:26 PM

#102652 RE: To infinity and beyond! #102607

Thanks... I'd been waiting for your follow up to the discussion. The only thing I'd like to add is to clarify that many make the mistake of not distinguishing between the Brilacidin phase 2a by PolyMedix and Cellceutix phase 2b results. I realize you know and understand the difference, but, others reading your post may not.

For those not aware, the statement "The one time dosing esp the 0.8 did as well as the 3 day so a once daily dosing is bound to be the future for B." was based on info from the Cellceutix phase 2b trial recently completed. And, I fully agree with this statement.

And, I'm especially glad to see you state the following: "I once again say that I do not see BP changes as an issue for Brilacidin." Thanks for being a contributor here. Your knowledge and experience are greatly appreciated. And, it's great to see you agreeing with my thinking on Brilacidin. ;)






In Reply to 'To infinity and beyond!'
Quick follow up to blood pressure discussion. Look at Brilacidin antibiotic fact sheet Feb 2013 put out by Polymedix. There is a discussion of adverse events including a statement that two patients left the study due to increased blood pressure. Those dosing regimens were different than those currently used- specifically, those were multiday and the recent phase 2 was two one day 0.6 and 0.8 as I suspect you all know very well. The one time dosing esp the 0.8 did as well as the 3 day so a once daily dosing is bound to be the future for B.

But it means that Jorgensen mentioned it 1) some patients do get BP increases, and 2)BP increases represented a real problem with the Polymedix phase 2 trial

I once again say that I do not see BP changes as an issue for Brilacidin. We will have phase 3 data to look at some day too.