Positive Results from Phase II Study for Diffuse SD

[Randy]

Perhaps others have seen this article that was part of this week’s SD Foundation Weekly Eletter. Any comments?

Randy

---

Daval International announces positive Phase II results for AIMSPRO

Diffuse SD since Apr '07
AP since Feb '08
100mg Mino twice daily
Stopped Clindamycin IVs Aug 2019
"No one should profit over someone else's illness"

[Maz]

Hi Randy,

I did a little reading on the pharmaceutical website about these trials and really don’t feel nearly qualified enough to comment on this drug with any degree of insight. That said, I think what concerns me most about it is this statement about how it is manufactured:

“It is a pharmaceutically derived biological product that is manufactured and processed using a unique specification that is patent protected and which is derived from a caprine hyperimmune serum source that has been immunised with an inactivated HIV IIIB viral lysate.“

Basically, it’s made from “hyperimmune” goat serum, which is isn’t biologically identical to human serum and effectively foreign to the human body. The “hyperimmune” wording is also bugging me…is its purpose to ramp up immunity to act as a catalyst for the inactivated HIV viral lysate? Maybe even more concerning is that they’re also using inactivated HIV virus. Does anyone really know the long-term effects of the inactive form of the HIV virus? So, if I’m getting the gist of this research, what they’ve created is a vaccine with dead HIV virus in a catalytic state?

A further question that comes to mind is what preservatives are they using in the vaccine, if any? One trial was canceled as it wasn’t being stored/handled (refrigerated/thawed) properly prior to giving it to patients, which may mean is has a very short shelf life and no preservative base.

I dunno, Randy…this one may turn out to be a life-saver for end-stage SD, but I’m such a doubting thomas until I see long-range outcomes of new drugs. Right now, it seems like they’re only doing trials in late stage SD, which would suggest there may be a better risk/benefit quotient on this in terms of it being life-prolonging in some instances. There are a lot of drugs that hold so much promise in trials, get released based on short-range studies, and then wind up producing severe side-effects later down the road. I must admit, the idea of what this one is made from unnerves me, personally, but can see how it may be providing hope for those with terminal illnesses.

I promise, I’ll eat my hat if I’m way off track on this! 😆 What were your thoughts about this drug when you studied it?

[Randy]

Maz,

Great comments!

I have no comments about the drug or study, nor have I studied up on it at all. Fortunately AP has worked very well and I don’t need to be looking into other protocols. However, I was very surprised that no one else had posted about it yet.

Thanks again.

Randy

Diffuse SD since Apr '07
AP since Feb '08
100mg Mino twice daily
Stopped Clindamycin IVs Aug 2019
"No one should profit over someone else's illness"

[MINOCINMAN]

From my readings there are 2 big problems with drug.
1. Very expensive for those with no RX insurance.
2. The very nature of SD illness makest very hard to know if the drug caused subjects to get better, or they would have got better anyway.

I have been advised by multiple experts that many will get better with no treatment, so without a large sample of people in trial the positive results mean nothing.

I fully support AP because we have large number of people are many years, per DR S that he has seen benefit. Strong anedoctal evidence, but no large study, which almost impossible to get with this illness due to rarity of illness, plus variability of illness and symptoms.
However, Randy thanks a lot for posting, as for some this maybe very important info since ABX may not be working and this could be an alternative or adjunct therapy.

[Author]

Posts