Promising Research Results! - I've attached both the links to the site and actual news release from New York on March 17, 2014

pbc-society.ca/research.html

globenewswire.com/news-rele...

[Hidden]

Hello nataline.

I did look at the links you posted. Had previously seen one like the pbc.society quite recently. The globenewswire.com I obviously hadn't.

As promising as it does sound and it does from what I could understand of it all (as some terminology can be very technical) the one thing that would actually make me very dubious would be the fact that it can cause pruritis and I started with the itch back in 2010 that started the ball rolling to PBC diagnosis for me. The itch has subsided quite a lot in the 3yrs I've now taken urso and my LFTs have improved greatly. I can currently tolerate the night time itching, more recently it has subsided that bit more but not sure if just fluke or the ongoing urso.

I know if comes the day that the medical profession are informed to switch to OCA and stop urso (UDCA) then I think I would have to have a good think about it for myself. Knowing how the itch used to be to what it currently is for me, I just do not want the itch to worsen with a new drug and also don't fancy any new temporary side-effects from it either. I'm not being negative here, I am sure a lot of others would be a bit sceptical. I've quoted the effects from the globenewswire site of the new OCA below so anyone can see why I chose my reply. I personally will if it is marketed in the future read the pharmaceutical literature for the OCA and then take it from there.

'Pruritus, generally mild to moderate, was the most frequently reported adverse event associated with OCA treatment (placebo: 38%, OCA 10 mg: 68%, OCA 5-10 mg titration: 56%). Eight patients discontinued due to pruritus: none in the placebo group, seven (10%) of the patients in the 10 mg OCA group, and only one (1%) of the patients in the OCA 5-10 mg titration group. Apart from pruritus, the incidence of adverse events was generally similar across both OCA and placebo groups (placebo: 90%, OCA 10 mg: 86%, OCA 5-10 mg: 89%). Overall, serious adverse events (SAEs) occurred in 22 (10%) of the patients and, although there were more SAEs in the OCA treatment groups, none were considered drug-related and there were no apparent patterns in the SAEs.'

[Hidden]

Hi Peridot,

Yes, I did see that Pruritis as a mild to moderate side effect of this study and surely does not need to be

made worse from anyone experiencing it.

If marketed, I believe that whether OCA works alone or in conjunction with Urso, the benefits would have

to definitely and significantly out-way the side effects.

Hope it happens soon no matter the study!

[Hidden in reply to Hidden]

Hello nataline.

I somehow seem to think that eventually OCA will be made into a tablet (or other form) with urso (UDCA) as a combined medication.

I am not sure if you have the itch but you would definitely not think that 'benefits would outweigh risks' as seems doctor speak these days if you did suffer from it every night. If for instance I was to take this new 'bile' then if I was finding myself itching most of the time I would more than likely opt out of taking it as to me I'd rather be comfortable during the day as I am now than spend all the waking day and nearly all the of the night stuck with the itch. To me that wouldn't be living.

[Hidden in reply to Hidden]

For sure, in your case, it shouldn't be made worse but hopefully by the time it comes to market they would have eliminated the "itch" side effect.

Glad to hear you are comfortable during the day.

[liver-bird]

Hi Nataline - thanks for sharing the links. As a 66 year old who was very recently diagnosed with pbc, I am very glad that people are working hard to improve our lot. Happily they seem to have a breakthrough which could significantly reduce deterioration of the liver. I am so sorry to see so many people suffer from bad itching - I get mild itching at present and hope it does not get worse as it must be miserable. Looking forward to hearing more about the new drug

[Hidden in reply to liver-bird]

Hi liver-bird,

Sorry, to here of your diagnosis and know that you will receive great support and encouragement on this site.

It sure is great to know that some day soon (hopefully!) these dedicated people will have something meaningful that will significantly benefit the liver.

Hope the itching won't last too long.

[Hidden in reply to liver-bird]

Fingers crossed liver-bird that your itch starts to subside somewhat by taking urso. Mine has sort of settled now in the last 3 yrs of taking urso but it has taken some time. The itch is apparently not something that urso apparently has an effect on with regards to it banishing the itch but I expect with better LFTs and improving health due to urso on PBC then it figures that the itch will somehow diminish somewhat. Not the case for everyone.

Sincerely hope that your itch remains mild as it is currently. I'd say these days mine is tolerable and being confined to night time some nights I can sleep, others I do find it disrupts.

[rosie456]

Does this mean there will soon be treatments available to completely halt the progression of pbc?

[Hidden]

According to this study, they believe that their data indicate OCA will provide a meaningful clinical improvement in PBC progression.

[Kind_of_crazy]

This is my first post. I am in the US and think there is additional information that everyone should review before becoming too excited about OCA.

OCA was developed by a US company called Intercept Pharmaceuticals. Currently, there are at least five (I stopped counting) class actions suits filed against the company in the US in regards to their FLINT study (using OCA for the treatment of NASH). The following quote is from an article on Reuters US edition:

reuters.com/article/2014/04...

"On January 9, 2014, Intercept announced that its Phase 2 trial of drug compound obeticholic acid (OCA) had been stopped early based on interim analysis showing that the primary endpoint had been met. Upon this news, shares of Intercept surged over 500 percent. Then on January 10, 2014, the National Institutes of Health issued a statement noting that while the efficacy primary endpoint had been met, participants in the study who had received OCA experienced "lipid abnormalities," including higher levels of "bad" LDL cholesterol. On this news, Intercept stock dropped from its $445.83 per share closing price on January 10, 2014 to close at $255.12 per share on January 14, 2014."

Intercept also failed to disclose that there were two deaths in Phase 2 FLINT study. You can Google class actions suits against Intercept in the US if you care to read further regarding lawsuits against Intercept.

Here is the link to the latest Intercept marketing material:

interceptpharma.com/wp-cont...

Reviewing Intercept's material you will be stunned, amazed, hopeful, all good things. The results they report for the POISE study (the use of OCA for the treatment of PBC) are truly astounding. However, however, however, Intercept has been already been caught not fully disclosing once. What does this say about the integrity of Intercept? Intercept has never had a drug on market, and this material is provided by Intercept to sell their stock. How reliable is this information? In the back of my mind, I keep hearing, "If it sounds too good to be true...".

I want it to be true. I hope it's true. It would be so nice to have a second treatment option for PCB. I think we deserve a miracle - or two.

[Hidden]

With all research there is the good, the bad and the ugly in it's process. There is a lot of trial and error before any new product comes to market. We'll need to trust the rigorous approval process (when and if it's gets to that point), and, even then, the final decision is ours to make on if it is right for each one of us.

Thanks, for sharing and, as you, I hope it's true.

[littlemo]

Thanks very interesting and hopeful research will be sure to ask about it when see my consultant next month. x