Rose Bengal as a chemotheaputic.

[GrouseMan]

I wanted to bring some additional attention to one of Garbovatwin news posts about ESMO GI providing new insights into HCC and metastatic liver cancer from other forms of cancer such as CRC. A lot of these insights I think seemed a bit disappointing for folks with liver mets or HCC. My father was recently dx with HCC quite by accident, and his cardiologist ordered a CT but didn't limit it to his upper torso, and they scanned his lower torso and got some great pictures of his liver showing a single Golf ball sized tumor in his liver. He has no risk factors and this is rare, unless it's a Met from another form of cancer, of if he had Hepatitis, or ate moldy peanuts! He has no other cancer that they can detect. So this is plenty rare. So since he is diagnosed with HCC, my wife had liver mets from her CRC, this caught my attention.

Nearly a year or more ago, on Linked In a friend I use to work with at the pharmaceutical company we were both employees before they shut down the facility, posted that the new company she started work for, had received a patent for use of an old well known compound called Rose Bengal as a treatment for cancer via direct injection into tumors. Primarily Melanoma. I contacted her and asked if they are doing other studies and at the time she said no not yet. But I expected as much because they really can't say publicly.

Now I see some preliminary work has been done with Liver tumors, Both HCC and from CRC mets! See the later part of this news article. http://www.medicalnewstoday.com/articles/296646.php

This is pretty exciting I think. Something as simple as this injected straight into the tumor once! It involves an immune response, and from what I have already read about melanoma, it may also prime this response against other mets nearby that were not injected!!!

Here is general information about Rose Bengal: https://en.wikipedia.org/wiki/Rose_bengal

Here is information about the company http://www.thelifesciencesreport.com/pu ... herapeutic.

And https://www.pvct.com/

This is not an exotic chemical compound its been known for a very long time and is commonly called acid red 94.

Regards,

GrouseMan.

[DK37]

Fascinating GrouseMan - thank you for posting.
As a priority I am going to do some digging into this...................
Cheers,
-DK

[smalltownmess]

Is the name for Rose Bengal as a chemotheraputic agent PV10? Did some quick googling and found this trial.. is this the Rose Bengal?

https://clinicaltrials.gov/ct2/show/NCT ... V10&rank=1

[Voxx66]

Thanks for posting this. Some great info here.

[CRguy]

Is the name for Rose Bengal as a chemotheraputic agent PV10? Did some quick googling and found this trial.. is this the Rose Bengal?
https://clinicaltrials.gov/ct2/show/NCT ... V10&rank=1

Yes that is it, in a specific preparation for a specific purpose.
In vet school we learned of its use as a stain for corneal ulcers, BUTT now just about everyone uses fluorescein clinically ...
so Rose Bengal as "chemo" is a great find as far as I am concerned !!!!

I am a huge fan of old drugs finding new and BETTER uses !
Let's see where this leads.

CR

[GrouseMan]

Is the name for Rose Bengal as a chemotheraputic agent PV10? Did some quick googling and found this trial.. is this the Rose Bengal?

https://clinicaltrials.gov/ct2/show/NCT ... V10&rank=1

Yes - That is indeed the one.

Regards,

GrouseMan

[smalltownmess]

Mentioned this to Dr. Fisher today at Stanford and he said he hadn't heard of it. He and his fellow did say they would look it up though. He did note that none of them were at academic centers, we'll see if we hear anything back.

[DK37]

I looked into the scientific literature, I wanted to post (2) very pertinent scientific papers/abstracts (I think both are free access so should work for anyone that wants to download).

1.) Preclinical paper where they begin to dissect the immune mechanism of action: http://journals.plos.org/plosone/articl ... ne.0068561
2.) Preclinical abstract where they discuss preclinical activity in CRC (Abstract #P134 on page S86): http://expo.jspargo.com/exhibitor/web/S ... tracts.pdf

Especially Ref #1 has a lot of scientific detail in it -- but some take home messages:
- Requires direct injection into a tumor, non-tumor injection showed no effect
- Certainly immune related, some non-injected tumors were impacted when a separate tumor in the same animal was injected with the drug (bystander effect). Even more interestingly, when they transferred immune system T-cells from treated mice into different mice, those mice were then resistant to tumor growth showing successful immune memory and transfer between animals.

This reminds me of local injection of oncolytic viruses, except in this case the local tumor is chemoablated. When local injection oncolytic virus therapy was combined with systemic PD-1 inhibitors in preclinical models, the PD-1 inhibitors really increased the anti-tumor effects throughout the body (i.e. "bystander" or "abscopal" effects). The authors admit that they are still trying to figure out why the immune system is taking such abnormally close attention to the way Rose bengal is killing the tumor. In general terms, this is called an "immunogenic cell death" - they are still figuring out the specific details.

Especially now that there are new potential routes to a systemic (abscopal) effect, it seems to me that there will probably be more and more intra-tumoral injection trials in the future. As a non-expert conjencture, it seems to me that using interventional radiology, it would be in-between a needle biopsy and RFA in terms of difficulty.

Definitely exciting times ahead in novel cancer treatment strategies!

-DK

[pukalania]

Thank you for posting that Grouseman and DK.. Asked onc about it but he said due to peri involvement not a good idea.. But wouldn't the peri mets get the bystander effect too? ... This sounds so promising ! It had a note for compassionate use on the company website but not sure if that's for HCC only... Thanks again!

[cnorton1960]

Just wanted to throw this out there - I only skimmed the messages but this whole post threw me for a loop - Rose Bengal being my grandma's name. Just brought back memories......

[alanrobertross]

Hi, I am new here but I have been doing due diligence on PV-10 (which is Provectus' formulation of Rose bengal) for years. My Grandmother died from CRC and my Aunt has been struggling with it for many years. I am also a cancer survivor so I have too much first-hand knowledge, myself.

Anyway... I read elsewhere that you were discussing RB here and I thought I might be able to help, so I registered for your forum.
Up front, I want you to know that I am so impressed with PV-10 that I bought stock in the company. I think this drug needs to get approved quickly because it is so effective. I also have a free part of my website that covers Provectus and its drugs. You can read the article without registering, here: http://www.trustintelligence.com/forum/index.php

I will give you a the Coles Notes version and then point out the most relevant part for people who have CRC or other solid tumors.

RB has been around as a stain for about 100 years. It was used in people to stain the eye and liver. It has a half-life in the body of only about 30 minutes. It does not harm normal cells.
PV-10 is highly pure RB in a 10% saline solution. It is injected into the tumor. It is most effective if as much as the tumor will take, is injected. PV-10 enters the cancer cells and kills it within days. The cell's debris cause the patient's immune system to be able to ID the cancer that was killed and t-cells proliferate and circulate through the body killing other similar cancers wherever they find them. In other words, if you inject a primary melanoma it can kill a met to the lung.

Most of the human work has been on melanoma and a Phase II trial was published last year. A Phase I trial in breast cancer was successful, as was/is a Phase 1 in liver cancer, which is continuing. The efficacy data has been better than existing treatments and side-effects are mostly pain from the injection. There are no systemic effects because it is not injected into the bloodstream.

There is a Compassionate Use Program but that is only FDA approved for cutaneous and subcutaneous cancer. People with other cancers (I believe including CRC) have been treated in the program because they had cutaneous or subcutaneous cancer too. You can see the details and who to contact, here: http://www.pvct.com/compassionateuse.html

The expanded Phase 1 Liver cancer trial is both for people with primary liver cancer (HCC) and for people with metastatic liver disease (MLD). CRC often metastasizes to the liver and in the trial, some people with CRC had their liver tumor treated (only 1 shot allowed in the trial) very successfully. The data has not been fully released but there is reason to believe that the immune effect made the liver injection also work on the cancer in other locations. This has happened for a few patients, who ended up with No Evidence of Disease, years later.

People with CRC with liver mets, who qualify can still get into this trial. I know they are looking for people with primary digestive system cancers that spread to liver, including pancreatic cancer, because PV-10 has been successful in preclinical tests with animals. So far, everything that has worked with animals has worked with humans when they tried it. You can get the trial information here: https://clinicaltrials.gov/ct2/show/NCT ... tus&rank=2

I will let it go at that now and leave you with the Provectus website www.pvct.com where there is lots more information.
I will check back later in case anyone posts any questions that I can answer.

[pacificnorthwest1]

Thank you for posting that Grouseman and DK.. Asked onc about it but he said due to peri involvement not a good idea.. But wouldn't the peri mets get the bystander effect too? ... This sounds so promising ! It had a note for compassionate use on the company website but not sure if that's for HCC only... Thanks again!

A sincere suggestion to all seeking PV-10 treatment information:

I am happy you discovered the sometimes hidden gem and remarkable PV-10 treatment.
For you or anyone who will pursue a PV-10, Rose Bengal cancer injection, treatment (made by Provectus Biopharmaceuticals) . . .

It is my strongest recommendation that you ask to speak directly with the treating physician ONLY, when you call the clinical trial location(s).
If the front line person insists on being able to answer questions, I would explain, it is about my life, and therefore very important to me, to speak directly with the treating physician ONLY.
I would call as often at it took, or have a friend call, until I found the opportunity to speak directly with the treating physician ONLY.


Reason for this suggestion?

When I called various trial locations, I confirmed every time, that the front line staff knows less about PV-10 than I do.
Sometimes they have recommended other treatments, which have serious adverse effects, sometimes even killing patients, and/or reached the highest success rate of 26% success.
In comparison, a PV-10 approximate success rate is something around 71%+ success, has no serious adverse effects, does not destroy healthy tissues, and the biggest side effect is described as local pain at injection which lasts only a short time.

(Important note: the approximate 71% PV-10 success rate is from past trials where all tumors were not yet allowed by the FDA to be injected. Past trials, medical professionals in the know and animal studies, give every reason to believe that future PV-10 trial success rate will be approximately around 80-90% or better, again, where all tumors are allowed by the FDA to be injected.


Again:
When calling a clinical trial site, I would only rely on answers from the treating physician, since the front line clinical trial staff have so far proven to be unreliable at best, regarding this remarkable, rarely known, breakthrough treatment which Even some medical professionals, who claim to be in the know, are still thinking it is too good to be true. The high success rate and bystander effect will sound too good to be true, I promise.
Reaching out to Alan Ross, who has a Trust Intelligence blog with extensive hours on PV-10 research, is a great resource also.
To let you know also: this recommendation, to ask for the treating physician only, when calling any clinical trial location, comes from important medical professionals who are in the know about the facts of PV-10.
I would NOT post this recommendation here, if I did not have reliable medical professional support

Current Liver
https://clinicaltrials.gov/ct2/show/NCT ... -10&rank=1

Current Melanoma
https://clinicaltrials.gov/ct2/show/NCT ... -10&rank=5

Highest Regards,
pacificnorthwest1

[Bev G]

Fascinating posts! I wonder if this could turn out to be "IT"?

[alanrobertross]

PV-10 isn't going to be perfect, but it is unlikely to be very risky.

Melanoma patients report the shot of PV-10 hurts, but that may not be the case for when they inject liver or other solid tumors. And it doesn't have systemic effects. No digestive problems, hair loss, etc.

The cancer that is injected usually dies in a couple of days if the tumor was pumped with enough PV-10 so it doesn't tend to postpone other treatments. In melanoma, biopsy of the tumor site, a week after injection found no live tumor cells to analyse in research by doctors at Moffitt Cancer Center in Tampa.

The immunological effect that can hunt down, attack, and kill uninjected tumors seems to take about a week to start working. It looks like the adaptive immunity that the PV-10 causes stays with you, although it is only good on genetically similar cancer. If another type of cancer arises or if there are mutations that exist, PV-10 should be injected into them to widen the adaptive immunity.

But keep in mind that PV-10 has not yet been FDA approved and you can only get it by being in a trial or the compassionate use program... if you qualify.
Qualifying is not easy and I explained that a bit in my earlier post. At this point, you need to have cancer in your liver or a subcutaneous or cutaneous cancer that is not amenable to surgical 'cure'. There are other rules too and you can see them on the clinicaltrial.gov website.

In my view, people with solid tumors need this drug, or one as effective as it has been show to be so far, approved ASAP.

[smalltownmess]

Hi alanrobertross,

Does using PV10 under compassionate use still mean that only one tumor can be injected per 28 days or are the guidelines more flexible? I asked the research coordinator at one of the trial sites but she has been slow at getting back to me.

Thanks!