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Blocking interferons might not be a good idea at the moment either :-)
Nolupus, I would not be able to say either way, but to be brutally frank Trump owns AZN now, so wait and see. Anifromulab side effects are significant, especially when (SS) Sjogren Syndrom plays a key role in Lupus and AZN new drug causes ( Shingels ) =ophthamalgic disease = ophthalmic zoster, that on its own bring long term problems and should be considered by anyone with SLE.
The FDA at present are suffering from Trumpism Syndrome, as he just forces through what he wants, and that is never been seen before.
Lots of Americans do just travel to Canada to buy there drugs, and soon when the boarder opens again, Americans will be visiting Canada , the USA drug pricing is the worst in the world.
AZN price fixing and fraud in the USA is well known
I would be interested in your opinion about anifromulab and it's chances of getting a FDA approval ?
I take your points on board, and have a very good understanding of Cancer Trials , these are changing, as now leading Cancer Hospitals do not use biotech companys or Pharma, everything some of them do is on site with there own scientists and patients receive novel treatments without the Bio Medical science and pharma being involved.
AS new Novel treatments come to the fore, then companys in this area will have to adjust.
Overlap syndromes in Lupus encompass SS= Sjogren’s Syndrome and aother Autoimmune disease that lead to Myocarditis, Cardiomyopathy's of different types .
To conduct trails in patients, it's imperative to know what drugs have been taken, how long for, the additional side effts and changes to the organs they have made. Ideally, on trails, it helps if the patient's selected are at varing stages of Lupus, (ie) newly diagnosed, but have had limited treatments, then others who have had the disease longer with multiple differnt treatments.
This is why I say you need a very good University Hospital that as say 5000 patients, and there history , as thise patients care as been under one roof in effect and that way you can get better trail results.
Of course this would not restrict a trail, as if you have multiple patients who have treatment at various Hospital s, you will see a different result, it then gives additional information of a trails success , but the key is, you may just find the biggest group from one University Hospital shows real promise and good results, compared to others in the trial..
Appreciate your post and the detail of it
We are all here to debate but we have to stick with the factual .
We are all awaiting news to fill in the gaps left by most of the RNS since the Avion partnership ..
FDA meeting was supposed to be in Q1 ...
What will be the primary endpoint ?
LLDas accepted by the FDA or not ?
Avion are doing this and that but we have not seen any concrete evidence of them doing anything, as MD said there is no mention of IMM on the Avion website .
We are all awaiting news to fill in the blanks but my patience is running low as it's time for action and not TALK ..
That said we may possibly have an RNS this week :-)
Nolupus: I owe you and apology. I wrote that I believed that the leading lupus patient organisation that Avion was consulting with in relation to the new Phase 3 for Lupuzor was the Lupus Foundation of America. I have not had confirmation from IMM that this is correct so until I do I have to leave this as speculation.
As to the identity of the KOLs recruited by Avion to likewise help in devising the parameters of the new Phase 3 trial, I think I conflated the KOLs with the three American members of IMM's Scientific Advisory Board. One of them, Dr Daniel J Wallace has an illustrious career in treating lupus. He has a CV as long as your arm; another, Lee S Simon, has a history of research in autoimmune diseases and now heads a consultancy which advises on devising trials for new drugs. The other members of this Board. one other American, the other two from Europe have similarly impressive research experience in this field. They may or may not be amongst the KOLs recruited by Avion although one presumes they are being kept fully in the picture.
But I nevertheless apologise if I have misled you or other readers on this site.
We are all awaiting the outcomes of the FDA meeting ...
The primary outcome of Lupus trials is the most important in my view ... will the FDA finally agree to allow LLDas ??
Personalised medecine is the way forward as some treatments will work effectively on some patients and not others depending on their individual bio markers
MD.J You are right to highlight the huge spectrum of autoimmune diseases and the overlaps between them. Indeed, the thinking is moving away from pigeon holing these conditions towards trying to understand the unique situation for each patient (an approach which is revolutionising cancer therapy). The devil, however, is in the detail and an immuno-modulator which works in one condition may fail in a related one whose pathways differ slightly. So, as far as the regulators are concerned, we are stuck with double blind trials - anecdotes just don't cut the mustard. And, as Lupus points out, doing trials in all the conditions you have mentioned is not feasible for reasons of finance and time.
I too am disappointed not to see Avion flag waving on their site, and am keen to hear details of discussions with the FDA. The longer this information is in coming, the more anxious I will be. This second trial really is 'make or break'.
They are not all, If you want a Deadly Autoimmune disease, then consider Amyloidodid, especailly when it effects the Heart.
Having details of Overlap Autoimmune disease that encompass Lupus is very important Nolupus, but you need to understand that and see how one treatment may assist in overlap to Lupus.
Its really a matter of having a understanding of these diseases, as if you do not and focus soley on one, then you miss the others.
TRy breaking Systemic lupus erythematosus into 4, so far I can only see one type that comes anywhere near Avion small pipeline of selling drugs.
They are trying to break into Dermatology, perhaps they would be better suited to selling Hydromol
It's all very well mentioning all the auto immune diseases but it takes time and money to do trials , and IMM don't have much of one or the other..imv
Patent runs out when again ?
Imm got up the noses of many lupus specialists in the last couple of years , so they might have difficulties arranging a kol meeting like they did for the last P3 trial .
We were supposed to have a meeting with the FDA in Q1 2020 but still no news , all we have had is vague announcements without any details or timescales and of course more dilution ....
It's time to deliver more than talk , imo
Immupharam are good at telling everyone what Avion are doing.
I can tell you now, no Physician, or Autoimmune MD at Johns Hopkins are involved and they are the world renown hospital for treating Autoimmune.
Have a look at Avion website on all there latest news. No MENTION of Immupharma. Wonder how many of these respected consultants understand Autoimmune Cardiology. Lets look at Avion latest news
From their last final results:
Post review period
– Avion strengthened advisory team for Lupuzor™ Phase III trial, including collaboration with leading lupus patient group and formation of KOLs – all senior respected consultants within lupus and autoimmune community in US/EU
CauldStream7 Avion have nothing on the website re IMM, why? AS to IMM stating something, if it's the case that AVION have stated it, where is the statement on AVION website?
My post of MAY 22nd 14.33 was clear on autoimmune diseases, that cross over and overlap diseases that link, all are long term conditions, some lead to "Axial Myopathy" as well. especially (DM) = Dermatomyositis which is Neurological
Part of the post which you say is not clear, study them and then you will see they are clear..Lupus can for into several categories . CTD, MCTD, UCTD . it also falls into overlap syndromes.
Investors could benefit from seeing a bigger picture with regard to Immupharma. How many have heard of Rhupus ?
You then have ( RA) Rheumatoid arthritis . (SS) Sjögren syndrome ( (SSc)Systemic sclerosis which is a disease that as many components , some found in Lupus and can be overlap syndrome . ( DM) Dermatomyositis That starts with a rash and is rarely diagnosed correctly till the disease is advanced . (PM) Polymyositis similar to (DM) but without the rash, ALL THESE CROSSOVER AND OVERLAP IN (CTD) (MCTD) (UCTD),
Mixed connective tissue disease (SLE) systemic lupus erythematosus (SSc) as another component which is Scleroderma part of Systemic Sclerosis, and then you have Myositis= Polmyositis-Dermatomyositis to a much lesser extent "Inclusion Body Myositis"
Could you post a link to your sources of who I see being lined up for the KOL and which Lupus organisation as to the best of my knowledge no details were disclosed ...
Re: For info.
Jonah58 and MDJM.
I very much appreceate your informed posts on Lupuzor. I'm not sure that I understand them 100% especially the various diseases of the immune system mentioned by MDJM and identified only by their initials.
As far as his last post is concerned in which he recommends that IMM makes contact with leading Lupus organisations, IMM told shareholders within the past 3 months that Avion has signed a collaboration agreement with a leading lupus patient organisation in the US. I believe it is the Lupus Foundation of America. It also has signed up what it calls KOLs Key Opinion Leaders. From reading their CVs they do seem to be very eminent in the Lupus field of research.
MD.J. There were several top quality academic units involved with the last P3 trial. I agree that subgroup analysis (sometimes unkindlyreferred to as data dredging) suggests that a further study of sero-positive patients might be revealing and I also agree that there is a good chance that this will turn out to be the case. I can't wait to see the entry criteria and pre-defined end points of the next study and see no reason why this information should not be coming soon.
The problem with these studies, imho, lies not in the academic credentials of the participating centres, but in the fluctuating nature of the disease and the difficulty of establishing meaningful end points. In this respect, I think the first study was over-ambitious and I am sure this crucial lesson has been learnt.
By way of illustration, any study will have to compare Lupuzor with standard care, which frequently involves treatment with steroids - a horrid therapy if given long term. If a patient in the Lupuzor wing completes the trial with no improvement in symptoms, but with a significant reduction in steroid dose this will constitute a huge benefit. I am sure these subleties will emerge in the design of the forthcoming study.
Pangolin.. It's time Immupharma got more involved with https://www.lupusresearch.org/stay-informed/updates-and-events/lra-news/
GSK, Takeda Pharma both have LUPUS drugs and treatments, RemGem have got a fast track with the FDA. Now is the time the Board of IMM start be more proactive and engage with Lupus Foundation, Lupus Research.
Reason for deal with Avion:
Need for money I suppose!
And thanks for your educated posts.
Lupuzor as much potential in Autoimmune and Neurological diseases, here is the caveat, the Trials must be conducted with major university teaching hospitals to see its full potential as a treatment.
I would say Avion is a stop gap at this stage, and I have reasons for saying that , which anyone can enlighten themselves to.
Personal preference link with Johns Hopkins or similar to take Lupuzor further. Its about having access to patients with Autoimmune Conditions where multiple treatments have been tried ..
There isa huge difference between a failed trial and a failed drug, Lupuzor was very much a failed trial, that fact will be proved by Avion, sometimes the wrong base is taken for a trial, I have seen reviews from people who were in the trial and they never felt so well as when they were on Lupuzor, they were so unhappy this drug was taken away from them. This has very little side effects compared to the alternatives and is a key to having a long happy life