Swedish trial of mercury binding substance IodoCarb ® for CFS

[Dolphin]

(I've copied a computer-generated English translation below. No questions to me, please - I just came across it on Twitter)

https://www.avanza.se/aza/press/news.jsp?newsArticleId=N1964331

PharmaLundensis: Klinisk studie mot kroniskt trötthetssyndrom inleds idag (Aktietorget)
2013-02-07 11:42

Rekrytering av patienter till PharmaLundensis nya kliniska studie inleds idag!
Studien är en Fas 1 + 2a "Proof of concept" dubbelblind placebo kontrollerad klinisk studie på 40 patienter med kroniskt trötthetssyndrom. Studien bedöms bli färdig hösten 2013. En positiv behandlingseffekt i aktuell studie kan leda fram till det första effektiva läkemedlet mot denna svåra sjukdom!






Idag inleds rekrytering av patienter till PharmaLundensis nya kliniska studie på kroniskt trötthetssyndrom (ME/CFS). Studien är en Fas 1 + 2a "Proof of concept" dubbelblind placebo kontrollerad studie på 40 patienter . Män och kvinnor i åldern 35-60 år kan deltaga. Hälften av testpersonerna kommer att erhålla PharmaLundensis kvicksilverbindande substans IodoCarb® och hälften får placebo (overksam substans). Studien är godkänd av Läkemedelsverket och Regionala Etikprövningsnämnden i Lund, och bedöms bli färdig hösten 2013. Personer som önskar deltaga i studien kan anmäla intresse enligt kontaktuppgifter i nedanstående annons.

PharmaLundensis VD Dr Staffan Skogvall säger: Det är med stor tillfredsställelse som vi idag kan meddela att alla förberedelser för PharmaLundensis nya kliniska studie är färdiga, och att patientrekrytering nu påbörjas! Kroniskt trötthetssyndrom är en stor sjukdomsgrupp med många patienter som lider svårt, och det finns idag ingen effektiv behandling. Vi hoppas att PharmaLundensis testsubstans skall visa goda effekter mot denna sjukdom!

Det kan också vara värt att notera att PharmaLundensis, i och med att den nya kliniska studien nu påbörjas, uppenbarligen har förmåga att driva kliniska studier på två viktiga sjukdomar samtidigt, trots små ekonomiska resurser. Detta är naturligtvis möjligt endast tack vare den höga kompetensnivån på bolagets nyckelpersoner samt dess samarbetspartners.



För ytterligare information:
Dr Staffan Skogvall
VD
Telefon: 046-13 27 78
E-post: staffan.skogvall@pharmalundensis.se


PharmaLundensis affärsidé är att utveckla nya och kreativa läkemedel mot sjukdomar som idag saknar effektiv behandling. En ny behandling mot den svåra lungsjukdomen KOL med IodoCarb® befinner sig i klinisk fas, och bolaget avser inom kort att starta kliniska studier mot fler svårbehandlade sjukdomar.




Har Du Kroniskt Trötthetssyndrom?

Vi genomför för närvarande en studie där man utvärderar ett helt nytt läkemedel för kroniskt trötthetssyndrom (ME/CFS).

För att kunna delta i studien krävs att:
- läkare har ställt diagnosen kroniskt trötthetssyndrom på dig.
- du är 35 - 60 år.
- du är inte gravid eller ammande, och har fullgott preventivskydd.
- du är för övrigt vid god hälsa.

Deltagande innebär att du besöker kliniken 3 gånger under ca 6 veckor. Dessutom görs ett uppföljande återbesök ca 3 månader efter avslutad behandling. Vid besöken får du genomgå en allmän läkarundersökning med bestämning av bland annat puls och blodtryck. Vi kommer även att ta EKG samt några blodprover. Du kommer dagligen fylla i ett livskvalitetsformulär, en dagbok där använda mediciner skrivs in, samt du får använda en stegräknare för att bestämma din fysiska aktivitetsnivå. Reseersättning utgår för klinikbesöken i studien.

Om beskrivningen ovan passar in på dig och om du är intresserad av ytterligare information om ovanstående studie är du välkommen att ringa till ProbarE i Lund, Ewa Karlsson på telefon 0732-300 450 eller skicka e-mail till: ewa.karlsson@probare.se

Ansvarig läkare för studien är Dr Anders Luts, Specialistläkare i Psykiatri.

Dina personuppgifter kommer att behandlas i enlighet med personuppgiftslagen (PUL).

Studien är godkänd av Regionala Etikprövningsnämnden och Läkemedelsverket.



Se nyheten från PharmaLundensis

Computer-generated English translation:

https://www.avanza.se/aza/press/news.jsp?newsArticleId=N1964331

PharmaLundensis: Clinical study of chronic fatigue syndrome starts today (Aktietorget)

2013-02-07 11:42

Recruitment of patients for PharmaLundensis new clinical trial starts today!
study is a Phase 1 + 2a "proof of concept" double-blind placebo-controlled clinical trial in 40 patients with chronic fatigue syndrome. The study is expected to be completed autumn 2013. A positive treatment effect in the current study may lead to the first effective drug against this devastating disease!




Today begins the recruitment of patients to PharmaLundensis new clinical trial in chronic fatigue syndrome (ME / CFS).The study is a Phase 1 + 2a "proof of concept" double-blind placebo-controlled study in 40 patients. Men and women aged 35-60 years can participate. Half of the subjects will receive PharmaLundensis mercury binding substance IodoCarb ® and half will receive placebo (inactive substance). The study was approved by the FDA and the Regional Ethical Review Board in Lund, and is expected to be completed by autumn 2013. Individuals who wish to participate in the study can apply under contact information in the following ad. PharmaLundensis CEO Dr. Staffan Skogvall says: It is with great satisfaction that we can now announce that all preparations for PharmaLundensis new clinical study is finished, and that patient recruitment is now starting! Chronic fatigue syndrome is a major disease group with many patients suffering from difficult, and there is currently no effective treatment. We hope PharmaLundensis test substance should show good effects against this disease! It may also be worth noting that PharmaLundensis, in that the new clinical study now begins, apparently has the ability to run clinical trials of two important diseases at the same time, despite limited financial resources. Of course this is only possible thanks to the high level of expertise on the company's key employees, and its partners. For further information: Dr. Staffan Skogvall CEO Phone: 046-13 27 78 E-mail: staffan.skogvall @ pharmalundensis.se PharmaLundensis mission is to develop new and Creative drugs for diseases that currently lack effective treatment. A new treatment for the severe lung disease COPD with IodoCarb ® is in clinical phase, and the company intends shortly to start clinical trials against more difficult to treat diseases. Has To Chronic Fatigue Syndrome?We are currently conducting a study to evaluate a new drug for chronic fatigue syndrome (ME / CFS). Participation in the study required that: - doctor has made the diagnosis chronic fatigue syndrome for you. - you are 35 - 60 years. - you are not pregnant or breastfeeding, and have adequate contraceptive protection. - you is otherwise in good health.Participation means that you visit the clinic three times in about 6 weeks. Furthermore, a follow-up visit approximately 3 months after treatment. During these visits, you will undergo a general medical examination with determination including pulse and blood pressure. We will also take ECG and some blood tests. You will fill the daily quality of life questionnaire, a diary in which to use medications are entered, and you may use a pedometer to determine your physical activity level.Travel expenses paid for clinic visits in the study. If the description above applies to you and if you are interested in further information on the above study, please call ProbarE in Lund, Dr Karlsson on phone 0732-300 450 or send e-mail to: ewa.karlsson @ probare.se responsible physician for the study is Dr. Anders Luts, Specialist in Psychiatry. Your personal data will be processed in accordance with the Personal Data Act (PUL). study was approved by the Regional Ethics Committee and Drug Administration.

 

[Seven7]

What is the theory behind this drug, that we have a mercury binding issue???

 

[Helen]

Hi Inester7,

They have noticed that people with CFS have about the same symptoms as people intoxicated by mercury (exposed in their jobs). As Iodocarb binds to mercury, and some people have gotten better when they tried the supplement, they now want to test if this group of people with CFS could get better from using it.
They don´t discuss if we have a mercury binding issue. They just suggest that a toxic overload might give us CFS.

Most people with ME/CFS, according to more than 200 Methylation Panels analysed by Rich Van Konynenburg, have a partially blocked methylation, with decreased level of glutathione. As glutathione binds to mercury, we also have "a mercury binding issue" , when low levels of glutathione.

I live in Sweden so I will follow the study carefully and let you know the results. Thanks Dolphin for the reminder!

Helen

 

[Little Bluestem]

That is the best computer generated translation that I have seen. What site/software did you use to do it?

I'm a little suspicious of the responsible physician being a psychiatrist.

 

[Dolphin]

That is the best computer generated translation that I have seen. What site/software did you use to do it?

Yes, I was surprised by it also.
It was Google Translate (on Google Chrome).
I was wondering perhaps was it written by somebody initially in English and translated into Swedish which might then improve a translation? I've also seen with some translation tools one can suggest better translations of particular bits, so perhaps somebody did that already???

 

[SilverbladeTE]

hm, interesting!
well I've used Selenium for while, ti seems to helps, I have a load of amalgam fillings and live in an incredibly heavy metal polluted area so I gave selenium a try as it's useful at removing mercury.

 

[Mimi]

You don't have to use a translator - it's posted here: http://www.clinicaltrials.gov/ct2/show/record/NCT01793415

The summary is:

Descriptive Information
Brief Title ICMJE Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Official Title ICMJE Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Brief Summary
Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
Detailed Description
Chronic fatigue syndrome (CFS, which is also sometimes called ME, Myalgic Encephalomyelitis) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. They often function at a substantially lower level of activity than they were capable of before they became ill. Besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. Often, CFS can persist for many years. Researchers have not yet identified what causes CFS, and there are no specific tests to diagnose CFS. The prevalence has been suggested to be around 1-2 %.
All humans are exposed to small amounts of mercury every day from the environment. It is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. It is also known that the sensitivity to the toxic effects by mercury differs greatly between people. Thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. Therefore, the question arises if a reduction of the mercury content in the body of CFS patients can improve their symptoms and problems in daily life.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
This is a double blind placebo controlled parallel group study.
Patient population: 40 patients diagnosed with CFS will participate.

 

[Mimi]

I have been doing Cutler frequent low-dose chelation to get rid of mercury and it has helped me more than anything else, with the possible exception of s-acetyl glutathione. Or maybe idebenone.

 

[A.B.]

I don't think iodated activated carbon can lower the body burden of mercury in any organs except the gut.

Iodated activated carbon could end up alleviating symptoms for a number of reasons, but the study design does not allow any conclusions to be made about mercury being involved as far as I can tell.

I don't want to come across as too critical though, I think trying new approaches is commendable and for this reason alone the study is worth watching.

 

[Mimi]

It doesn't need to. The gut is extremely well-vasculated, so something in the gut can pull mercury from the blood. The blood is in turn supplied with mercury from the tissues. For more info, watch some of Chris Slade's videos on YouTube.

 

[A.B.]

It doesn't need to. The gut is extremely well-vasculated, so something in the gut can pull mercury from the blood. The blood is in turn supplied with mercury from the tissues. For more info, watch some of Chris Slade's videos on YouTube.

That's how layman imagine it works, but it doesn't. If it did, micromercurialism wouldn't exist because the blood clears itself of mercury within a few days.

 

[Mimi]

You mean me, or Chris Slade? While I am a layman (albeit and educated one) Dr. Slade has a PhD in chemistry. He did his dissertation on mercury detoxification. He consults with Hal Huggins and Dietrich Klinghardt and has done a lot of original research in the field. All of his statements are backed up by evidence, using the world's most sensitive mercury testing to date.

Dr. Slade has shown how mercury levels drop in the bloodstream during chelation, and then rise back up as they seep out of the tissues into the blood. Furthermore, he has the only test that I know of which can distinguish between forms of mercury stored in the body - methyl, elemental or an inorganic salt. This gives us clues as to source and location - something no other test can do.

The beautiful thing about that test is it's totally safe. No drinking DMPS or DMSA and then retoxifying the body by moving mercury around and making things worse. Furthermore, his company's product - Quicksilver Scientific Intestinal Metal Detox - is much, much safer than chelators that go in the blood. And it doesn't pull out minerals the way DMPS and DMSA do.

If you have ME/CFS then this is well worth looking into. Mercury is everywhere and we are constantly getting re-exposed. If you have ever had amalgam fillings, they are 50-70% mercury. And even if you have had them removed safely - following very strict protocols that few dentists are trained in - you still have a body burden of mercury to detox. Something we don't do very well.

As for the blood clearing itself of mercury - which I assure you it does not - where do you think that mercury goes? If you have ME/CFS by definition your detoxification systems are overloaded. Mercury accumulates in those systems and screws them up. It has an affinity for the heart, liver, brain, thyroid and adrenals. And now that we have better testing, we know it stays in the blood.

 

[dannybex]

You mean me, or Chris Slade? While I am a layman (albeit and educated one) Dr. Slade has a PhD in chemistry. He did his dissertation on mercury detoxification. He consults with Hal Huggins and Dietrich Klinghardt and has done a lot of original research in the field. All of his statements are backed up by evidence, using the world's most sensitive mercury testing to date.

Dr. Slade has shown how mercury levels drop in the bloodstream during chelation, and then rise back up as they seep out of the tissues into the blood. Furthermore, he has the only test that I know of which can distinguish between forms of mercury stored in the body - methyl, elemental or an inorganic salt. This gives us clues as to source and location - something no other test can do.

The beautiful thing about that test is it's totally safe. No drinking DMPS or DMSA and then retoxifying the body by moving mercury around and making things worse. Furthermore, his company's product - Quicksilver Scientific Intestinal Metal Detox - is much, much safer than chelators that go in the blood. And it doesn't pull out minerals the way DMPS and DMSA do.

If you have ME/CFS then this is well worth looking into. Mercury is everywhere and we are constantly getting re-exposed. If you have ever had amalgam fillings, they are 50-70% mercury. And even if you have had them removed safely - following very strict protocols that few dentists are trained in - you still have a body burden of mercury to detox. Something we don't do very well.

As for the blood clearing itself of mercury - which I assure you it does not - where do you think that mercury goes? If you have ME/CFS by definition your detoxification systems are overloaded. Mercury accumulates in those systems and screws them up. It has an affinity for the heart, liver, brain, thyroid and adrenals. And now that we have better testing, we know it stays in the blood.

Mimi, I agree that the test sounds promising, however it's my understanding that his 'instestinal' product isn't considered "much, much safer" than say ALA, which Cutler as you know, used and recommends. I had heard that it's only used once or twice a day, which would have the ALA in it redistributing mercury in the body. Do you have any info to back up the 'safer' claims? And/or have you asked about this on the FDC yahoo group?

Thanks in advance Mimi,

Dan

 

[Mimi]

Hi Dan - It's been a while since I borrowed the Cutler protocol, but if I recall correctly, ALA doesn't bind mercury as strongly as DMSA. That's why he suggest taking them together, and taking DMSA every four hours around the clock.

I did 7 rounds of the Cutler protocol this spring, and added ALA on the last two rounds. My experience was that ALA greatly increased my symptoms temporarily, to the point where I was nearly as sick as I was in the first two rounds.

If ALA moves mercury in the brain, as Cutler contends, that would probably explain it. Given the strength of the reaction, I'm glad I was taking DMSA around the clock, along with s-acetyl glutathione, coffee enemas, charcoal, diatomaceous earth, Pectasol, NDF+, Liver Life, and so forth. Even so, the mercury kicked my butt right until the final day of detox.

Regarding your last two questions, I didn't know about the Yahoo forum, but I'm glad there is one. For safety information, I recommend Chris Shade's in-depth presentations. His work is very thorough.

Mimi

 

[dannybex]

Interesting, thanks for replying Mimi.

I did about six-seven rounds of ALA back in late 2009 -- wish I could turn the clock back and continue where I left off. I had no problems with it at all -- even waking up at night to take a dose wasn't so bad -- and generally felt "better" during during that time. So in hindsight, I took my "health" for granted, and stopped chelating because...I dunno...I wasn't as sick as other locals with CFS so I guess I thought I knew everything. Hindsight's always 20/20, but sure wish I hadn't wasted these last four years...oy!

It's my understanding that ALA does bind mercury as well as DMSA, and is in Cutler's view the only compound that can cross the BBB, but that DMSA may help lower the overall body burden relatively faster. Sometimes it's recommended to start with (can't remember why right now!), although Cutler used ALA alone when he chelated. It was too pricey for me, so I went with low dose ALA.

I'd recommend checking out the FDC group. I believe you can check out the posts without joining, so if you're interested in hearing contrasting opinions on the safety (or not) of various compounds claimed to chelate. Let's just say for example, that NDF -- or worse, anything with chlorella or cilantro -- isn't looked at very fondly.

Thanks -- I'll check out more of Shade's videos...hope he has some info on the ingredients in his products.

 

[Sparrowhawk]

Just researching this based on Mim's recommendation. The Chris Shade videos on youtube are quite clear and enlightening about mercury in our metabolism and how to get it out. Do you know if anyone on Phoenix Rising has used his approach/product?

dannybex can you give me any more info on where to find that yahoo group? Is that an acronym or abbreviation of a longer group name I can search on? Thanks.

and Mimi when you say you did rounds of the Cutler protocol, how many days in a row is each round, over how many weeks or months? Thanks again.

 

[dannybex]

I sent you a PM Sparrowhawk, but for others, here's the link to the group:

http://health.groups.yahoo.com/group/frequent-dose-chelation/

 

[Sparrowhawk]

Thanks very much on both accounts! Just joined there. Between this and the MTHFR stuff I'm a bit overwhelmed but it's all so intertwined. One practitioner is telling me all the viral issues will work out once my mercury burden is reduced, others are saying do antivirals...and there's debate around the safest way to do mercury chelation...argh.

 

[Mimi]

Mimi[/USER] when you say you did rounds of the Cutler protocol, how many days in a row is each round, over how many weeks or months? Thanks again.

Hi Sparrowhawk,

I did it based on muscle testing as well as intuitive reading, so not the standard Cutler protocol. My rhythm was 3 days on and 2 days off. And it was hell. Just to warn you.

Mimi

 

[Mimi]

I also have another friend on PR who is doing the Quicksilver protocol. He's quite happy on it and expects to go back to work in October.