Good news

[donna01]

Came across this earlier and been meaning to post. Help could be closer than we think. Positive thoughts! pipelinereview.com/index.ph...

[Hidden]

Hello donna01.

I hve just read your posting. I am a bit of a sceptic at times and to me though this seems that it might be of some breakthrough in PBC I think at this stage in event of it being given that go-ahead eventually (I did read that it can take 10yrs from the study of clinical trials for new medications to be devised and then to trials to approval before it is marketed), I think it might just become a next step after the urso.

Anything is good news but when I was looking online to see if I could find further info on this NG... trial, articles seem the same. I did find London Mercury website and if you are to click on the 'read more' it takes you to an American site and it basically states the same as your posted link.

I know for me, given I read that the itch of PBC didn't seem to be altered by this trial in my case being an itcher is not something that I could readily accept for myself.

I also read that originally the trial was for diabetes and in this event, I do think that perhaps if marketed for use in PBC it might well alter certain other things with our bloods whereas for me, as much as I dislike having to take a medication every day apparently for the remainder of life, urso doesn't actually cause any other alterings or side-effects in my case.

I'm no 'party pooper' here, forgive me if thought. I think any input is interesting and I somehow have this way of thinking that with everything that is thought of and yes with these trials, I think one day someone out there is going to stumble upon something and then we will have some definite answers.

Here's my link I found....

londonmercury.com/index.php...

[donna01 in reply to Hidden]

Hi Peridot,

I understand you are skeptical, but to me, any news/breakthrough is good news. I'm wondering if the study you came across for the diabetes , if perhaps a diabetic has the same issue as someone with PBC, the FGF19 Hormone? Just a thought since PBC has been thought to be hormone related . Also, I am curious, where did you read that it could take up to 10 years for this? I did not see that anywhere

[Hidden in reply to donna01]

Hello again donna01.

I once did read and I am certain it was on the NHS Clinical Trials website the route of the formation of a possible clinical trial for something to the planning and then organising which then has to be accepted at each stage before it can ever be considered for marketing and it stated that it can take around 10yrs from the original thought to final use if approved. When one considers that pharmaceuticals have to get on board and that magic word that seems to control life - money - then it all adds up in time. I'll see what I can find and re-post it on here.

I did see that there was a mention of this N trial something that you posted originally on here earlier as trialled for PBC but it also mentioned about diabetes in the same article I read too.

I still have that stance here that to me the way forward for us in PBC isn't attempting to control it but to eventually find something that will eradicate the antibodies that are being produced that keep the PBC in motion. If a cure for these was found tomorrow I personally would still expect whatever damage has already been started to remain as we know bile ducts cannot rejuvenate themselves like the

liver can (to a certain stage) but it to be completely stopped.

I have just found an article on an unrelated site to PBC (Alzheimer's one - I'll pop the link on) and will quote here what it states re clinical trials. I didn't originally read it on this one but it is roughly what I originally read though this states slightly longer than the 10yrs I posted.

"Designing a new drug

Once a target has been found it can take many years to develop a drug from scratch. However, often there are existing drugs that are good candidates. This helps to cut down the time required.

A new drug must go through several rounds of testing before trials in humans can begin. First it is tested in cells grown in a laboratory to check that it will work. Next the drug is tested in an animal model for safety and toxicity, and to see if it has the desired effect. This process takes 3 - 5 years.

Testing a drug in people

Only then can a drug start trials in humans. Clinical trials progress in a stepwise fashion, gradually involving more people. It usually takes 8 - 10 years for a drug to be licensed. Each increasing step is called a 'Phase' and there are four phases:

Phase I: Checking for side effects and testing the dosage. Usually about 30 people

Phase II: Does it work in the people with the condition? The drug is tested against a placebo. Usually about 200 people

Phase III: How effective is it? The drug is tested in hundreds or thousands of people and can then be licensed for medical use.

Phase IV: How does the drug perform in the long-term? This involves following people over a series of years.

In total, it takes an estimated 15 - 20 years to develop, test and license a new drug."

alzheimers.org.uk/site/scri...

[cazer in reply to Hidden]

Hi peridot the problem is that it sounds as if for you urso lessens the itch...unfortunately I myself and lots of others do not get any benefit in this way for the itch and need other options. I went on urso 16yrs ago and at the time was quite new and mainly being used for gallstones. ..so unfortunately every drug is not proven really until people have been on it longer term. I think I also one of first to use it whilst breastfeeding but I had a premature baby who was underwait due to having pbc whilst pregnant! Although not with 100% diag at that time. ...so needs must in some situations. Also my lfts were pretty bad so they had to try and do something. Obviously it is each to his own but not everyone s circumstances are the same and that has to be taken into account.

[Hidden in reply to cazer]

Hello cazer.

I do think that it might be a case of someone starting urso and how they are with the PBC. I was said by the hospital consultant to have probably had PBC 'a few years'. The itch alerted me to see a GP after a fortnight of 24/7 itching. This was March 2010 and I had to endure the itch until Dec 2010 when I was diagnosed and then longer. I'd say that the itch only really started to feel that more settled a couple years ago. In the earlier days of taking urso I did after around 6 months start to have odd nights where I didn't itch but that's not been the case in the last year, I've had the itch ever night, some times it can be rather intense but others notso.

It seems that for everyone with PBC and taking urso the itch can vary. I have read on this site by one contributor who I've not seen in a couple months now that her itch vanished when she started to take urso and she seems to have been free of it over the years by doing so. Others have you have stated found they got no relief or change whatsoever by taking urso.

I know reading the Patient Info Leaflet with the urso, they do state that it is a case that it doesn't actually be known to have much of an effect on pruritis (itching) nor fatigue in PBC.

Maybe also it depends on your age when you are diagnosed with PBC. I was 45 when I started to itch, 46 at diagnosis and in a few days I will be 51.

[mayday-Yeah]

Thanks Donna am interesting read.

whoever finds a cure for the itch will b a very rich man^woman.

[butterflyEi]

Thank you for sharing. Any interest in PBC has to be a good thing. Someone somewhere will get a breakthrough sooner or later which I hope will come sooner rather than later.

best wishes

[liver-bird]

Thanks for this Donna - its good to know that great minds are applying themselves to improve the lot of us pbcers

[cazz22]

Thanks Donna .any publicity /news is good for pbc sufferers as it's not common and therefore not a high profile disease.its really up to us to shout loud i guess

[mayday-Yeah]

Thanks a veryinteresting read.

[donna01]

Why was everything deleted from here? I seen notifications from Mayday-Yeah, cazz22 and liver-bird and Peridot, and only Peridot's response is here? Awfully strange to say the least.

[donna01 in reply to donna01]

The notifications and lag in this site is really bad.

[skippydownunder]

Hi Guys. I am actually on the trial and did this 28 day phase. The ALP, ALT and AST all reduced significantly. I am now doing another 52 weeks for them. ALP is down to 341 at last blood test. The bilirubin has gone up since stopping methotrexate for the trial but according to gastro it is OK. But we can only see. Because the 28 day trial was blinded for ALP we could not see the final result after 28 day phase but it was over 600 before beginning. We can now see the results monthly and it has been gradually reducing. It was 473 at beginning of next trial (52 weeks) and as I said it is now 341. ALT went from 239 - 66 and AST from 102 - 48 since the beginning of 52 Week trial. Bilirubin is 32. I am up to week 32 in May so will see then. Yes the symptoms are mild headache and loose stools but nothing you can't cope with.

Skippy

[donna01 in reply to skippydownunder]

Skippydownunder, are you referring to the NGM282 study that I posted above?

[donna01 in reply to donna01]

That is awesome Skippy! Your ALT/AST numbers are remarkable! Please let me know how the rest of the trial goes

[skippydownunder in reply to donna01]

Will keep you posted. The numbers do look much better than at the beginning. I am feeling less tired as well.

[skippydownunder]

Yes