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Author Topic: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,  (Read 4470 times)

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Offline John2038

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #1 on: April 19, 2010, 05:57:33 AM »
pharmaceutical business review

Immuron Completes Coral HIV Phase 2 Trial

Immuron, a biopharmaceutical company focused on oral immunotherapy, has completed the treatment phase in its Phase 2 double blind placebo controlled clinical trial (the Coral trial).

The trial was designed to test the Immuron hyperimmune antibody product BioGard as adjunct therapy to support the immune system of HIV patients undergoing long-term treatment with anti-retroviral drugs. The trial also involved the anti-retroviral drug Raltegravir in a combination of treatment regimes.

The trial was conducted by the National Centre of HIV Epidemiology and Clinical Research based at the University of New South Wales in Australia. All patients have completed their treatments and all trial samples are being processed at laboratories throughout Australia, including laboratories at the Universities of Melbourne and New South Wales.

Immuring said that the trial was sponsored by the National Health & Medical Research Council (NHMRC) via a major program within the National Centre of HIV Epidemiology and Clinical Research.

During the six month treatment phase within the Coral study, there was patient retention and compliance, with 68 of 73 participants finishing their allotted courses of treatment. Immuring is expected to release the full clinical trial results in June/July 2010 when all testing is completed.

The results will include both primary (immune marker measurements) and secondary (changes in plasma viral load and T cell counts) clinical endpoints. These results are expected to indicate the effectiveness of Immuring antibody product in improving immune markers both with and without the antiviral drug.

If the trial results are positive, Immuring is expected to partner with a pharmaceutical company possessing existing anti-retro viral drugs. Preliminary contacts with pharmaceutical companies have been made and will be accelerated when the trial results are known.

Grant Rawlin, CEO of Immuring, said: “We are delighted that this clinical trial has proceeded so smoothly within the expected time frame. We eagerly await the results, which if positive, due to the large global market for chronic support products for HIV patients, will have a positive impact for Immuring and also for the many patients being treated with anti-HIV drugs.”


Source

Offline veritas

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #2 on: April 19, 2010, 08:26:36 AM »

Haloo, John,

This research sounds interesting, however, when I try to get to Immunon's web site, I keep getting an error message. Were either of you successful in reaching their website?

Thanks,

v

Offline xman

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #3 on: April 19, 2010, 01:10:39 PM »
Please consider that this is an adjunct and not a replacement of HAART. We need to see how far we can benefit from this. Adding another drug to the already heavy regimens don't seem a good idea if it needs to be processed by the liver.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline J220

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #4 on: April 19, 2010, 07:31:03 PM »
Please consider that this is an adjunct and not a replacement of HAART. We need to see how far we can benefit from this. Adding another drug to the already heavy regimens don't seem a good idea if it needs to be processed by the liver.

When the option is immune failure then this is a good idea..there are ways to work on liver issues....there are less ways to work with HAART failure. So, this is good news, all in all.

What meds are you on, Xman, if at all? I ask because you seem to have a rather staunch opposition to any news regarding meds development. Just curious...
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline xman

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #5 on: April 19, 2010, 08:29:06 PM »
When the option is immune failure then this is a good idea..there are ways to work on liver issues....there are less ways to work with HAART failure. So, this is good news, all in all.

What meds are you on, Xman, if at all? I ask because you seem to have a rather staunch opposition to any news regarding meds development. Just curious...

There are still many issues relatied to HAART and we don't know what effects it will have after decades of therapy. It is now 15 years that we have HAART but the tendency is more to keep such drugs rather than finding a valid alternative.

Many specialists are happy and compliacent with the current therapies. Excellent. If everything is so marvellous why we still need prevention? I mean HIV is now chronic and nothing else than taking a pill everyday, right? OK it's expensive but many patents are running out and in a couple of years you'll have a regimen for the cost of a chewingum.

Billions were spend in making a preventive vaccine which never pan out. If we invested this money in a therapeutic vaccine or even a cure perhaps HIV would be a bad remind of the past. Please tell me one big company which is consistently investing in finding a cure!

Sure there are many small biocompanies studying and conducting trials but beeing realistic nothing is ready for approval. It seems that this disease is really no big deal anymore and not only for the pockets of the big investors.

Interestingly only now more effort is taken into a cure. What was done in the last 25 years? Now it seems obvious that we can't take all HIV infected on therapy for a lifetime but this problem is not new and was there even a decade ago.

My impression is that we are loosing more and more the control over the epidemic. Here in Europe 60% of new diagnosed are in AIDS stage which shows an absolute lack of testing. Do you think the actual estimate of infected folks worldwide is accurate? Personally I would double that number.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Boze

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #6 on: April 19, 2010, 09:32:08 PM »
Xman,

I think you are mistaken. There are a lot of different new methods being tried to replace HAART. They are of course NOT done by the big pharma companies because current treatment is a goldmine for them. If a cure were to be announced tomorrow, their stock capitalization would drop by tens of billions of dollars.

However I believe in Capitalism. Let's say some scientist figures out a way to fight HIV - there will be people investing money in this because of the huge monetary benefit they stand to gain. So you don't actually need big pharma behind this.

Also - with regard to your question why for 15 years we have no new treatment options, only variations on HAART. I asked that question to someone I know who works on HIV and he said that there has been a huge progress behind the scenes. What we take for granted - that ARV keeps the virus suppressed and unable to mutate (assuming proper adherence) - is due to the new drugs developed.  So actually staying in place without moving forward (ie being able to have a normal life on ARV) is progress since people are not dying from AIDS as they used to.

What worries me is the lack of new drugs in the last 5 years. Stuff like Atripla - which is kinda the latest word - has been around for 5-10 years. Reading the literature I am hoping that new drugs are being developed but will take time to go through trials. The good thing is that all the scientific work done in the last 25 years is the foundation on which today's scientists can rely on. It's like an inverted pyramid - the more time passes, the more we know about the virus and have more chance to find a cure.
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline xman

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #7 on: April 19, 2010, 09:42:48 PM »
So actually staying in place without moving forward (ie being able to have a normal life on ARV) is progress since people are not dying from AIDS as they used to.

No drug company will ever warrant that we will not die from AIDS. This is an assumption but not a certainty as long we have the virus in the body. We have this drugs for 15 years. How can we make the statement that HAART is able to completely prevent the death from AIDS? There's also a risk, even if remote, that a supervirus could bypass current regimens leaving us without any option. It's a timebomb that can explode anytime. We don't know what really is doing the virus when suppressed. Perhaps if it keeps reproducing in sanctuaries where current drugs are unable to get, the virus could become resistant in the long term even if undetectable. I think we are playing with something that can explode in our hands and we risk to not be prepared. Current HAART is a bandaid and will not help us for the rest of our lifes.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Boze

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #8 on: April 19, 2010, 09:55:17 PM »
"No drug company will ever warrant that we will not die from AIDS."

Nobody makes that claim. However, if you take a large group of HIV+ people on ARV and analyze how many of them die over a certain time-period, you can work out the probability that it happens. And the probability (for those who started before cd4 dropped very low) is similar to HIV- individuals.

"Perhaps if it keeps reproducing in sanctuaries where current drugs are unable to get, the virus could become resistant in the long term even if undetectable."

I don't think you understand the science behind this (at least as I do).

First - a mutation occurs when there is a weak form of ARV in a person's body (which happens if you stop taking the pills - some drug is still present but in quantities not sufficient to kill all virus). Half of the virus are killed by the drug still present and half are not. Here EVOLUTION takes place - the half that survives will actually have the mutation necessary to circumvent the drug.
Virus cells that are "hiding" in a place that's inaccessible to the drug - like bone marrow - can not produce a mutation in the virus because NO drug gets there in the first place. Mutation only happens where drug can get but in a weak form.

"Current HAART is a bandaid and will not help us for the rest of our lifes."
  Well - first of all it's a bandaid that people 10 years ago did not have. Second - if you look at the postings in this forum you will see how many different other non-haart ways are being developed. You have to understand that science moves in jerks. There is a quiet period when current methods are improved on for a while..and then someone has a big insight that changes the whole playing field. It happened over and over in every scientific field (see here: http://en.wikipedia.org/wiki/The_Structure_of_Scientific_Revolutions) I am hopeful that a simillar fate awaits this field. However it's impossible to predict when the change can happen - you just need enough smart people doing the work and having access to resources they need.
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline J220

  • Member
  • Posts: 587
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #9 on: April 19, 2010, 11:00:19 PM »
There are still many issues relatied to HAART and we don't know what effects it will have after decades of therapy. It is now 15 years that we have HAART but the tendency is more to keep such drugs rather than finding a valid alternative.

Many specialists are happy and compliacent with the current therapies. Excellent. If everything is so marvellous why we still need prevention? I mean HIV is now chronic and nothing else than taking a pill everyday, right? OK it's expensive but many patents are running out and in a couple of years you'll have a regimen for the cost of a chewingum.

Billions were spend in making a preventive vaccine which never pan out. If we invested this money in a therapeutic vaccine or even a cure perhaps HIV would be a bad remind of the past. Please tell me one big company which is consistently investing in finding a cure!

Sure there are many small biocompanies studying and conducting trials but beeing realistic nothing is ready for approval. It seems that this disease is really no big deal anymore and not only for the pockets of the big investors.

Interestingly only now more effort is taken into a cure. What was done in the last 25 years? Now it seems obvious that we can't take all HIV infected on therapy for a lifetime but this problem is not new and was there even a decade ago.

My impression is that we are loosing more and more the control over the epidemic. Here in Europe 60% of new diagnosed are in AIDS stage which shows an absolute lack of testing. Do you think the actual estimate of infected folks worldwide is accurate? Personally I would double that number.


You are entitled to your views. but so am I, and it is my belief that your views are utterly clouded by fear. I still have no idea if you are on meds or not. Perhaps you are not, and are dreading the day you must start them? Maybe, I don't know.

But I will say this: the "bandaid", as you call it, that is HAART, is the sole reason I am ALIVE right now. Without it I would not be here writing this. I celebrate the existence of meds, as opposed to looking at whatever drawbacks they may have, and most of what you are writing about them is pure speculation- i.e. "a supervirus timebomb lurking within us that will explode someday"- that's just plain fear and paranoia speaking, I'm sorry.

So fine, you can view meds as bad thing that leaves much to be desired, but for me, and for many of us here, I owe my life to them. Would I like a cure?...well of course....but at least, when and if they do come up with one, I trust I will be around to celebrate it thanks to: you guessed it, HAART.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline John2038

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    • HIV Research News (Twitter)
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #10 on: April 20, 2010, 03:33:04 AM »
xman,

the purpose of the Phases studies (if others that will follow if approved) is among others things to answer such question (lipid profile). Let see then what will come out.

Offline xman

  • Member
  • Posts: 288
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #11 on: April 20, 2010, 01:18:48 PM »
So fine, you can view meds as bad thing that leaves much to be desired, but for me, and for many of us here, I owe my life to them. Would I like a cure?...well of course....but at least, when and if they do come up with one, I trust I will be around to celebrate it thanks to: you guessed it, HAART.

I'm not questioning the success of HAART but I try to be realistic on what we need to put into account reguarding the future. It is not only the meds but the entire problems related to this condition. The legal system still sees this disease as a death sentence. If HIV is really so manageable and treatable like anybody says why there's so much criminalization and stigma? Why are there is people sentenced to 25 years of jail because they might infect someone? Perhaps we should comunicate that everything is different now and that HIV is something you can live with. Doing so more people would find the courage to get tested.

The problem is that we still need to disclose, we need to protect others and we have many responsibilities to take that others, the scientific community and the media, never were able to manage. A cure of even a therapeutic vaccine would put the disease under a new view. Still now many are seeing this disease as it was 20 years ago.

We have meds that keep us alive but we don't know what we need to pay in terms of toxicities.

I invite you to read the following article:
http://www.thebody.com/content/art55438.html
 

 
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline tommy246

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #12 on: April 20, 2010, 02:00:33 PM »
I think it is a chronic managable disease if you have been infected and on haart since the less toxic drugs have come along like atripla. The early drugs did alot of damage and were very toxic but many people who took the early meds are doing great on the modern meds albiet not without problems. Its also very important to realise with hiv life does change you need to eat a good diet not drink and party to much , take your meds and get good rest.
jan 06 neg
dec 08 pos cd4 505 ,16%, 1,500vl
april 09 cd4 635 ,16%,60,000
july 09 ,cd4 545,17%,80,000
aug 09,hosptal 18days pneumonia cd190,225,000,15%
1 week later cd4 415 20%
nov 09 cd4 591 ,vl 59,000,14%,started atripla
dec 09  cd4 787, vl 266, 16%
march 2010  cd4 720 vl non detectable -20  20%
june 2010  cd4  680, 21%, ND

Offline Pepino2

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #13 on: April 20, 2010, 06:14:55 PM »
Its also very important to realise with hiv life does change you need to eat a good diet not drink and party to much , take your meds and get good rest.

Now that's the tuff pill to swallow.

Pepino  ;)
« Last Edit: April 20, 2010, 06:16:29 PM by Pepino2 »

Offline xman

  • Member
  • Posts: 288
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #14 on: April 20, 2010, 08:36:31 PM »
However I believe in Capitalism. Let's say some scientist figures out a way to fight HIV - there will be people investing money in this because of the huge monetary benefit they stand to gain. So you don't actually need big pharma behind this.

Sadly this is only partially true because they need a big pharma company with the necessary resources to put the new drugs on the market.
« Last Edit: April 20, 2010, 08:39:55 PM by xman »
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Boze

  • Member
  • Posts: 477
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #15 on: April 20, 2010, 09:11:05 PM »
Sadly this is only partially true because they need a big pharma company with the necessary resources to put the new drugs on the market.

Yes - but every big pharma company would be bending over backwards to work with this upstart. Their livelihood is at stake - and they know well that if they don't do it, all other companies would. They probably wish that half the world was living on ARV in perpetuity - but there are enough interested parties to see this through if a viable solution is found.

Look at how successful horse industry has been at stopping cars (google red flag laws).
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

Offline MitchMiller

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  • Posts: 482
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #16 on: April 22, 2010, 01:03:24 AM »
The unfortunate reality is that sometimes market leaders "protect" their market share by being the first to spot a potential competitor, buy it, then bury it... at least until the patents on their current cash cows expire.   What they will do is ensure patent protection over the acquired new acquisition is airtight... so no other company can use it to compete against them... and their market share is safe.  I could easily see Gilead doing this since they are clearly the leader in HIV drug sales with at least 70% of new patients starting off with Atripla.

This makes good business sense because it allows a company to maximum profits over the patent lifetime of a drug... then choose whether or not to move forward with another treatment medium.  Companies hate to cannibalize their own cash cows.

Offline xman

  • Member
  • Posts: 288
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #17 on: April 22, 2010, 01:38:58 PM »
The unfortunate reality is that sometimes market leaders "protect" their market share by being the first to spot a potential competitor, buy it, then bury it... at least until the patents on their current cash cows expire.   What they will do is ensure patent protection over the acquired new acquisition is airtight... so no other company can use it to compete against them... and their market share is safe.  I could easily see Gilead doing this since they are clearly the leader in HIV drug sales with at least 70% of new patients starting off with Atripla.

This makes good business sense because it allows a company to maximum profits over the patent lifetime of a drug... then choose whether or not to move forward with another treatment medium.  Companies hate to cannibalize their own cash cows.


That's exactly what's happening. Big pharma decides what will be available for us. Please try to be realistic. Let's say Sangamo will succeed with their gene therapy. They will sell the chemical formula or product to a pharma company which of course will buy it. Sangamo is happy because they get back the money invested for studies, and the industry keeps the patent. If they see that it wouldn't have the potential of a blockbuster or would limit the sales of their actual top brands, they will not put it on the market immediately or they will exploit at a maximum all the drugs in their arsenal.

A gene therapy or therapeutic vaccine might be difficult to administer and even very expensive. As long as capitalism, how we know it now, tells the rules, I fear we will not end this situation soon.
Perhaps insurance companies or the government can influence a bit this reality but as long as tax payers provide the funds to substain therapies for those in need, no one feels the need to change this system.

Please note this is not conspiracy theorizing. This are simple rules of a society based on profit. This logic is applied every day in Wall Street, on the Nasdaq. What drives their decision is the stock value and not if you develop lipo in your face or build resistance to a drug.
« Last Edit: April 22, 2010, 01:58:15 PM by xman »
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Inchlingblue

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Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #18 on: April 22, 2010, 02:28:01 PM »
The contracts for buying the patent rights in biotechnology are very complex. Smaller companies that spend years and lots of money developing something that ends up being a clear "home run," are not going to agree to a multi-million dollar buyout and walk away.

The real money lies in the long-term royalties paid out during the life of the patent (the small bio-tech companies that develop a product get royalties). Once the patent has been issued the time clock is ticking until it expires. There are all sorts of contractual stipulations to ensure the product is exploited by a certain date or the rights revert. Do you think these people are idiots and are going to just sell to Big Pharma to have the product shelved?
« Last Edit: April 22, 2010, 04:25:51 PM by Inchlingblue »

Offline Boze

  • Member
  • Posts: 477
Re: Immuron Ltd. Announces Phase II trial of BioGard in U.S.,
« Reply #19 on: April 22, 2010, 02:43:31 PM »
What Blue said :)

You are also forgetting that governments + insurance companies are spending Billions of dollars a year on HIV/AIDS (about 60bn dollars last i saw). So they have a lot of vested interest in seeing a solution developed and put to use. Let alone the fact that governments can do what they please - they write the laws, even the money spent on drugs is only a small portion of all spending (only 12bn).

So I dont' think that the hypothetical 'evil' pharma company could wager that kind of battle against everybody else who wants access to a developed cure.
==========
Aug08 - Seroconversion
Mar10 - Diagnosis; cd4 690 - VL 19,000
Apr10 - cd4 600
May10 - VL 4,500
Jun10 - started Atripla ; VL 113
Jul 10 - UD vl, CD4 590
Aug 10 - UD, CD4 810, 52%
Nov 10 - UD, CD4 980

 


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