Oral formulation of salmon calcitonin – DMOAD

sturge8

I have been reading lots about this drug, it is in it's Phase III clinical studies to be a possible DMOD. Has anyone heard of it or know about it? Has many drugs in the past got to a Phase III clinical study and then failed? Should I be getting my hopes up that we may have the first drug which actually helps OA sufferers?

Trials for efficiency and safety end 2011, researcher said to me it could go to market in 2 years depending on results of course.

Please can someone respond, as I am getting quite excited that this could be the thing we have all been waiting for.

dreamdaisy

I haven't come across this but then, not having OA, I'm not surprised. I hope it does herald an era of hope for those with OA. Don't get too excited tho, there's a long way to go. DD

speedalong

Hi Sturge - no not heard of it either. I have OA, so would be interested to learn more. Any links you can post for us?

Speedy

sturge8

speedalong wrote:

Hi Sturge - no not heard of it either. I have OA, so would be interested to learn more. Any links you can post for us?

Speedy

try this link

http://seekingalpha.com/instablog/128183-joseph-ramelli/29508-the-most-undervalued-biotech

Phase III trials are underway.

sturge8

another link

http://www.thefreelibrary.com/Emisphere+Announces+Initiation+of+Phase+III+Clinical+Program+of+Oral...-a0163856213

sturge8

another link

http://www.clinicaltrials.gov/ct2/show/NCT00704847?term=calcitonin&rank=4

sturge8

dreamdaisy wrote:

I haven't come across this but then, not having OA, I'm not surprised. I hope it does herald an era of hope for those with OA. Don't get too excited tho, there's a long way to go. DD

Hi DD, when you say "there's a long way to go" What do you mean? What do they have to do after phase III of a clinical trial? How long would the next thing take?

If the drug is successful what would they be waiting for? It's been in the pipeline for a decade.

Extract from:
TARRYTOWN, N.Y., May 24 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. ("Emisphere") has been notified that Novartis Pharma AG and its development partner Nordic Bioscience have initiated the Phase III clinical program of oral calcitonin for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. The oral calcitonin product is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis(i),(ii).

dreamdaisy

Certain phrases give the game away, don't they? Bearing in mind I am not a clinical trials drug researcher the words 'initiated Phase 3 clinical trials' hints that a) it's still in research territory so b) it's not in production yet for wide-range usage, then you have the phrase 'new drug candidate' - candidate to me means someone/something seeking a rank or position, ie not elected yet, or in this case not manufactured, confirming the fact that it's not yet in production. American research probably won't be valid over here, our drug companies would want to do their own trials/tests - are they already? Then it has to get past NICE. DD

sturge8

dreamdaisy wrote:

Certain phrases give the game away, don't they? Bearing in mind I am not a clinical trials drug researcher the words 'initiated Phase 3 clinical trials' hints that a) it's still in research territory so b) it's not in production yet for wide-range usage, then you have the phrase 'new drug candidate' - candidate to me means someone/something seeking a rank or position, ie not elected yet, or in this case not manufactured, confirming the fact that it's not yet in production. American research probably won't be valid over here, our drug companies would want to do their own trials/tests - are they already? Then it has to get past NICE. DD

As far as I know the clinical trials are being conducted globally. Here in Britain the trials are being held at a surgery in Bexhall on Sea. Why can't American drug companies sell their drugs here?

dreamdaisy

I don't know. I know many things but not that. Would you like me to find out? DD

speedalong

Hi Sturge, only just noticed you have posted links ... shall take a peek tomorrow.

Speedy

sturge8

dreamdaisy wrote:

I don't know. I know many things but not that. Would you like me to find out? DD

Hi DD

I basically am very new to all this arthritis stuff. I am 29 years old and was told I have OA in my great toe joint and ankle all due to joint injuries. Doc says there is no cure and send me to an ortho, ortho has done a bit of shaving of bone in the ankle and injected my toe with cortisone. Thats me done in their eyes. I wasn't satisfied that this is all modern medicine can provide, so I googled cure for OA and this drug came up on the first page. My investigations have found that it's been globally clinically trialled and seems to be a winner. My knowledge of how drugs get to market are limited, so yes DD if you can enlighten me as what happens next with regards to this drug. I would be very grateful. I have even spoken to Arthritis research about it, they claim they have never heard of it. Why is it such a mystery?

dreamdaisy

Oh, poor you, only 29 and facing this. I'm 51, been battling with PA for over thirteen years now, only knwoing for the past 3 1/2 what it is. There are 78 joints in the human body and 31 of mine are affected.

It is an unfortunate fact of life that there is no cure, as yet, for any form of arthritis. Arthritis is a pernicious disease, once you have it it does not go, it does spread, but at what rate and to what joints varies from person to person, and the type you have. OA can be 'treated' with fish oils, to maximise joint fluids - and basically, that research in America sounds like the next step in that. People with OA have been taking cod liver oil, chondroitin, glucosamine etc and may have felt the benefit. If you're not doing that, START! If you only have a small area affected (and I am not undermining the effect of it, but it is limited at the moment) then you may be able to stave off its development, or at least slow it.
The text is jumping, I've lost my setting. Part 2 will follow.

dreamdaisy

Right, I hope that's done it.

From what you have said the docs have done all they can, and it is all they can do. We live in an age where we expect instant cures for everything, from hunger to boredom to illness, but the truth is they are not there. What works for one person does not for another, you have to keep trying different things until you find the result that suits you. Exercise is beneficial: I take it you are not on sticks or anything, so walk and cycle as much as you can to strengthen your bone density, that could also help. Many people on the forums with OA are very active and it must make a difference.

Drugs wise, marketing them is a tricky business. It's a multi-multi million dollar/pound business, there are many versions of one drug, investment is very intensive, and they do have to be very careful in how they trial and what they pass. Thalidomide children, now adults, are an excellent (tho very sad) example of a rush to promote a drug that cured morning sickness. I don't know the whole history, but it must have lacked some form of trialling because the manufacturers were unaware it would cause birth defects.

Different countries have differing standards and rules and NIHCE are quite fussy, as we know. They look at cost more than benefit, hence the postcode lottery on Aricept for example. You came across this research by accident: there is world-wide research going on and not everyone can know everything. My fingers are giving out, can't do much more. You are in the early stages, there is much you can do to help yourself, research diet and supplements. The meds that are involved in 'treating' RA and PA are extremely toxic to the body, I regularly inject, and am injected with, medical poisons. If you can manage with swallowing fish oils etc then that is good. DD

woodbon

Hi, I have OA and I was reading up some research papers, I came across a study that's being conducted in Nottingham, I think, (sorry to be vauge). It looked interesting and was looking for volunteers at the time.

I read a fair few articles and it seems that research medics are taking more of an interest on oa now. There are lots of theories as to why certain people get it, not being a medic myself I admit that more than half of it I didn't understand! So, it looks as if it's being treated as a serious disease, not just that horrible phrase, 'wear and tear', which makes me feel like an old dress, all faded and holey and the hem comming down!!!

I am sorry that you have this painful condition, which is hard to find any medicaions that really work, it takes approx 10 years from a scientist thinking something may help, to the drug being on the market and these days NICE stick their noses in and say its too expensive! But maybe we have hope for the future.
Love Sue

frogmorton

Hi Sturge

Havent seen you on for a bit. You ok?

This does sound very interesting doesnt it?

Have you posted to the helpline? they tend to be able to find stuff out?

Love

Toni xx

border

If this is true, it will be really marvellous

sturge8

frogmorton wrote:

Hi Sturge

Havent seen you on for a bit. You ok?

This does sound very interesting doesnt it?

Have you posted to the helpline? they tend to be able to find stuff out?

Love

Toni xx

What is the helpline?
I spoke to someone at NICE this morning. They didn't give me any bad vibes about the drug being not passed by them. I think the drug would cost $4/day according to this guy http://seekingalpha.com/instablog/128183-joseph-ramelli/29508-the-most-undervalued-biotech

This doesn't sound anymore expensive than the combined cost of my daily supplement intake.

dreamdaisy

Look at the top of the screen - there's a number that starts with 0808. There is another forum where you can post enquiries, there's a little box at the bottom of the posts where you can select the forum to which you wish to jump. The same box also appears under the submit button of a posting screen. Find out if there are trials in your area and see if you can join. Failing that, move to America!

sturge8

dreamdaisy wrote:

Look at the top of the screen - there's a number that starts with 0808. There is another forum where you can post enquiries, there's a little box at the bottom of the posts where you can select the forum to which you wish to jump. The same box also appears under the submit button of a posting screen. Find out if there are trials in your area and see if you can join. Failing that, move to America!

I think moving to America is a bit drastic.

link to the drugs trial from the NHS

http://www.nres.npsa.nhs.uk/researchsummaries/?EntryId29=19017

It says at the bottom Opinion: Favourable

DD. You seem quite knowledgable, are you an expert? If not how could I get an opinion from a rheumatologist and put my mind at rest once and for all.

I think we all need some kind of hope to cling onto, if this is it lets try and look at all the good things connect with SMC021. For sure I have not yet come across anything which says it does not work. Fingers crossed.

dreamdaisy

Fairly knowledgeable yes, thanks to 45 years of rubbish health, but as stated elsewhere rheumatologists do not usually deal with OA. I think that it is primarily caused by 'wear and tear', advancing age, stuff like that, so not really relevant to rheumatology. RA and PA have a different systemic cause, the immune system going haywire and thus the body attacks itself.

I have a degenerative, inflammatory arthritis to which fish oil etc makes no difference - my joints fill too easily with synovial fluid, hence the regular joint drainings and steroid injections of the past. This is why I take the medical poisons, to reduce the activity of my immune system in order for my body not to attack itself. The drugs do not treat anything, they are trying to inhibit/slow the progress of the disease and not doing too well at it either. I was born with an over-active immune system, it's always been part of life. The plus side of the meds is that I can now eat fruit and stroke a dog with no ill-effects. What a boon.

I think I can understand your frustration - you are comparatively young, and now an OA affected big toe and ankle is threatening your sporty and active lifestyle. That must be hard to come to terms with, plus you are male and therefore have a lower tolerance of pain than a female. What else can I say? I will swap conditions with you now: then you can have all the rheumatological attention you want, with foul meds, fortnightly blood tests and lots and lots of lovely pain! Yes, we live in an 'instant' world, which is a shame because that does not prepare one for the absolute fact that these conditions cannot, as yet, be cured. We all feel it too. Personally, I am looking forward to death, whenever and wherever it occurs because then, and only then, will it all stop. I am not in any rush for that tho - I only have 31 joints affected - I want the whole set! DD

sturge8

dreamdaisy wrote:

Fairly knowledgeable yes, thanks to 45 years of rubbish health, but as stated elsewhere rheumatologists do not usually deal with OA.

Rheumatologists treat arthritis - OA is a form of arthritis, so I would value their opinion as to whether this salmon Calcitonin could be potentially any good. Lets see what Arthritis UK report back to me, they have promised to get the opinion from their in house rheumatologist with regards to Oral Salmon Calcitonin.

dreamdaisy

Have you considered going for a private consultation? Perhaps you should, you do get faster answers that way. I will not bother you any more. You have taught me a valuable lesson and I thank you for that. DD

sturge8

dreamdaisy wrote:

Have you considered going for a private consultation? Perhaps you should, you do get faster answers that way. I will not bother you any more. You have taught me a valuable lesson and I thank you for that. DD

A private consultation with who? What is the valuable lesson which I have taught you? Don't worry, you aren't bothering me.

dreamdaisy

A rheumatologist.

sturge8

sturge8 wrote:

Rheumatologists treat arthritis - OA is a form of arthritis, so I would value their opinion as to whether this salmon Calcitonin could be potentially any good. Lets see what Arthritis UK report back to me, they have promised to get the opinion from their in house rheumatologist with regards to Oral Salmon Calcitonin.

reply from Arthritis Uk:
Our spokesperson, Professor Conaghan of Leeds University sent me the following comment in reply to the link you forwarded on to me:

“Calcitonin is an effective hormone for treating osteoporosis. Its use has been limited by nasal and injectable preparations but safety generally good. Its been shown in animal models of OA to have effects on improving subchondral bone and to a lesser extent cartilage, and in a small human trial to reduce symptoms in OA knee. Now big studies are underway to examine its effect as a structure modifying drug in OA – I haven’t seen the phase III results yet but I am sure if there is anything we will hear!”

So I guess the bottom line is that it may be one to watch".