Latest Statement from the MD of Daval

A forum to discuss Aimspro (Goat Serum) as a possible therapy for MS

Latest Statement from the MD of Daval

Postby Nemotoday » Tue Jul 20, 2004 5:04 am

http://www.davalinternational.com/markup/about.cfm

A message from the Managing Director of Daval International.

“Daval’s mission is to make "Aimspro'" available to all those who wish to take advantage of its therapeutic properties, as quickly as possible.

To attain this goal we need to achieve certain clinical, regulatory and commercial objectives which I am confident we are on course to do. The first is in our own hands and those of our eminent team of scientists. Increasing vocal patient demand will add weight to our regulatory submissions, and a projected partnership with a larger marketing organisation will assist in attaining the third objective.

As so many friends of Daval are aware, Aimspro is particularly suited to the treatment of neural disorders, such as multiple sclerosis, although we are becoming increasingly impressed with its applicability to other disorders of an inflammatory nature. The 150 patients who are already receiving Aimspro on an informed consent basis all attest to its efficacy. Daval is confident that those receiving it on the authorised trials currently taking place in this country will provide a similar endorsement in due course.

We are keeping the appropriate government departments regularly apprised of the development of our remarkable medication in anticipation that they will help Daval to fast track its general availability.

We feel it would certainly be in their interest to do so as we are already achieving significant savings for the National Health Service by freely treating patients. When the product's true potential is fully realised these savings would amount to many, many millions of pounds. This would also be consistent with the Government’s frequently stated intention of strongly supporting the British bio-technology industry.

Daval has a growing number of supporters who are assisting its progress with their varied skills and the Board is most grateful for their continuing encouragement during this crucial development period.”

Brian Quick. July 2004

Looks like they are trying to get help from the UK patients and apply peer pressure.

Regards to all.
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Re: Latest Statement from the MD of Daval

Postby Daunted » Tue Jul 20, 2004 10:24 am

I'm guessing a barrage of letters would not hurt. I'll write one.

What is the appropriate regulatory agency in England?

I'm going to write one to the FDA, also.
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Postby Felly » Tue Jul 20, 2004 11:02 am

The NICE committee (far from nice) make recommendations on treatments

http://www.nice.org.uk/

It may be worth contacting the MS society to ask them who to direct letters as NICE only meet twice a year or so.

They have an article on the site with the name of the MS society contact for information about the drug - you could hassle her.

http://www.mssociety.org.uk/news_events ... _drug.html

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Re: Latest Statement from the MD of Daval

Postby adjanimals » Tue Jul 20, 2004 1:44 pm

Excellent,
Something out there that's working. This needs to be pushed.
If only the US-NMSS would take a look at this.
Knowing them they'll find some way of discrediting it like they did with LDN.
Reading other info on Goat serum, to me this a positive deal, bad thing is it will take years to get into the pipeline. I was dx in 1993, I'm tired of waiting, I'll try it no matter what. Hats off to the teams in the UK. at least your doing something. Funny how the goats are raised in the US and nobody over here did anything. I live in the US.
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Re: Latest Statement from the MD of Daval

Postby finn » Wed Jul 21, 2004 9:20 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 9:26 am, edited 1 time in total.
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Re: Latest Statement from the MD of Daval

Postby Daunted » Wed Jul 21, 2004 12:25 pm

finn wrote:I hate to be a killjoy, but I believe that at the moment Goat Serum is very easy to discredit if one wishes to do so. So far there is no preclinical or clinical data about the drug, only anecdotal evidence.

But hopefully it will be as effective as the hype around it has made us hope it is, and also available sooner than thought.

-finn


Finn, you are technically correct about the science surrounding Goat Serum. But there are few things I find about Goat Serum that I find especially intriguing, and which may give us some reason to hope.





The experiments they were describing where people could see better immediately after injection, are also intruiging.

I think this is what people with MS want- a drug that will actually improve their quality of life. I know the ABCR drugs are often credited with this, but it's mostly through studies that are pretty suspect in my opinion. What I usually hear from people on ABCR drugs is, "I don't know if it's doing anything for me, but I take it because it is supposed to help."

With Goat Serum, it appears that for some people it might be obviously helpful.





So I'm hopeful for those reasons. If the trial of 40 people is a success, they need to follow it up with a long-term large multi-national trial. (Of course if it shows obvious success in 40 people, that means the drug works pretty well).

If it appears safe after this initial trial, I'm hopeful that the various regulatory agencies will be reasonable about this unconventional drug.

Something else to ponder- if it really does work well, but people have difficulty accessing it because of regulatory agencies, we might have a situation where there is a black-market for Goat Serum, much like AZT in the 1980s. I hope we can avoid that.

But I'd pay a lot of money to take 8 or 10 injections and see what it did to me.

But overall Finn is correct in reminding us that this trial- of only 40 people - could indeed fail, and that we need much more evidence.
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Postby markchip » Fri Jul 23, 2004 1:41 pm

Hi All,

Firstly some personal background on me... one of those 150 from the informed consent pre-trial days.

The "goat-serum" was first known as Caprivax but has been renamed Aimspro quite recently. It was initially developed as an HIV treatment but an incredible range of other conditions respond even better as it has turned out. MS happens to be the first one to get explored much deeper and things are looking very promising.

Aimspro has not been licensed yet but we hope that it won't take long and that means that any practitioner or neurologist can't prescribe it as yet. People who use Aimspro are either those on trials or from the pre-trial days as guinea pigs (such as myself). The treatment has been free for those on the trials - the company uses the money from investors and shareholders to treat people until the product is licensed in addition to its trial and other responsibilities.

I am one of the worst, if not the worst responding case so far! And I'm as happy as Larry to be on it! For me it started 6 years ago with a very severe balance disturbance with leg weakness and although the balance improved over the next few weeks, the legs never did. Over the following 3 years I went from walking awkwardly to using a wheelchair, with big downward steps in times of stress. My diagnosis was one of secondary progressive ms.

I was introduced to Daval via a friend and thought, "What the hell - I've nothing to lose!", so I became a guinea pig. 2 days after my first shot, I was able to turn in bed for the first time in over a year and a wide range of other small changes started to happen. Anything from fewer leg tremors to improved speech and being able to stand at the toilet without wobbling or holding on! (It's a guy-thing I'm sure you will empathise with!!)

So I did improve but not nearly as dramatically as others who were able to walk after years in wheelchairs, throw away frames or sticks, stop worrying about bladder and bowel control, etc., etc.. Several cases have been quoted in the press this year - I'm sure you will have read about them. For the past 3 years since I've been on the serum my downhill progress has been utterly halted and even reversed in some areas. I now use a walking frame rather than a wheelchair and I'm still driving - something I was sure I was going to have had to give up by now. Just recently I have taken unaided steps for the first time, I walked into the living room and back into the kitchen - around 30 (very slow and cautious) steps! I have had good improvements all round. Mind you, with MS any improvement is a good one! My legs are generally a lot stronger, I don't get tired as I used to, my appetite has returned too and I am very positive for the future as I expect more improvement as soon as my divorce is behind me (as the stress is accepted as often the single most damaging event for MS sufferers). I am now living with my partner and we want to get married as soon as we can, something I never thought would happen to me! I had resigned myself to a life of ever more limited scope, decreasing fun and increasing disability and loss of independence. I now know that this doesn't have to be the case - at all!!

I was seen by Prof. Angus Dalgleish, one of the lead scientists with Daval and a world leader in his field, when I started the treatment and he told me that even if my progress was only halted and not reversed then this would constitute a minor miracle. Well I'm living proof of miracles then!

I shouldn't really get your hopes too high just yet as there are still legal hoops to jump through and then the process of selling the license, then production and distribution, so it will take a while yet. That said, when Aimspro gets licensed there will be no time lost in getting it to market.




I thought you might also like to know about a meeting I went to two nights ago. It was about starting a lobbying and support group to help speed up the process of getting Aimspro into circulation, as one of its aims.

The good news is that we have agreed to open invitations to all parties to participate, with the exclusion of Daval and trial personnel for obvious conflict of interest reasons.

What we are proposing to get off the ground asap is an organisation to lobby for the promotion of the trials, licensing and general awareness of Aimspro, the serum. Naturally we cannot fund-raise for Daval - that area would have to be limited to funding for our own cost of operations which, we hope, will be quite low. There is still a lot else we can do, from lobbying our MPs and other influential people to asking questions of our GPs and consultants. This is where ordinary people like us (sufferers, family and friends on the informed consent pre-trial list - like me, patients on the trials themselves and equally those who would might have an interest in speeding up the process of making it available to the general population) can have a big impact because "people power" is a very effective tool indeed.

We are expecting to include in our short-term aims a website with general information on the treatment (downloadable), press articles, case histories, individual contacts (mainly patients) who would be willing to talk or email with public enquiries about treatment, others who could handle media enquiries and similarly to re-direct enquiries about investment. Other suggestions, such as a discussion board, charitable status and organisational fundraising, are also being looked at.

Regards, Mark


I will submit a posting when the website is up but in the meantime a "barrage of letters" demanding action from the authorities may help but also bear in mind that Daval, as a very small company with an awful lot on their plate right now, won't realistically be able to respond to such letters and the careline now in operation can't absorb a deluge of enquiries either. Those of you who might want scientific data will be disappointed as nothing will come out before the trial results are published (some before the end of the year?) and intellectual property can be safeguarded - there's a lot at stake here!
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Postby Daunted » Sat Jul 24, 2004 4:05 pm

I haven't seen this question raised yet...the answer will have to be quite speculative, but I'm still wondering if anyone has a guess, at least:

Any idea how much Aimspro will cost monthly?

(i.e., will it be $1200 a month like Copaxone, or something more reasonable..)

Since they are going for license in England first and the NHS will be purchasing most of it initially, I suspect they would want to show a clear cost improvement as opposed to the ABCR drugs, so I wonder if that will keep the price lower.

Just wondering.
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Postby markchip » Sun Jul 25, 2004 5:53 am

Regarding the cost of Aimspro...

At the moment the product is effectively "handmade" and therefore very expensive. However we (the patients and other investors) have been reliably told that costs of the serum in mass production will be VERY much cheaper indeed. One of Daval's aims is to be able to reach a very large proportion of those it can benefit and that will have to include the implications of cost. I believe that cost will therefore not be a major problem in the uptake of Aimspro. Beta interferon is without doubt rather expensive and, benefits aside, that factor in itself has been a problem for healthcare providers in the UK. It is anticipated that Aimspro will not face the same problems of high cost.

That said, we are not at that stage yet - Aimspro needs for the trial results to be published first and then a license to be granted.

Regards, Mark
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Postby Daunted » Sun Jul 25, 2004 2:58 pm

markchip wrote:Regarding the cost of Aimspro...

At the moment the product is effectively "handmade" and therefore very expensive. However we (the patients and other investors) have been reliably told that costs of the serum in mass production will be VERY much cheaper indeed. One of Daval's aims is to be able to reach a very large proportion of those it can benefit and that will have to include the implications of cost. I believe that cost will therefore not be a major problem in the uptake of Aimspro. Beta interferon is without doubt rather expensive and, benefits aside, that factor in itself has been a problem for healthcare providers in the UK. It is anticipated that Aimspro will not face the same problems of high cost.

That said, we are not at that stage yet - Aimspro needs for the trial results to be published first and then a license to be granted.

Regards, Mark


Mark,

Thanks for the information, tentative as it all must be at this point.

You mentioned, "patients and other investors". Are all the informed-consent patients also investors in Daval?

That seems like an unusual arrangment if true.
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Postby markchip » Sun Jul 25, 2004 4:50 pm

Not all patients on the informed consent list are investors by any means. I am not one myself, but that's simply because I don't have the wherewithall at the moment (I wish it was otherwise!). There is absolutely no connection between the two. There are patients, there are investors and there are those who are both. That said, when it became possible to buy in a lot of patients had absolutely no hesitation! It should be a good move financially but for many of us who were patients first and investors second it was a matter of doing our bit to help support the company that has done so much for us already. As I said, the handmade nature of the product as it is now (before mass-production) makes it expensive and Daval has never asked for any payment from any of us. It has been a matter of doing the research to get to the point of successful licensing, initially by informed consent and latterly by full-blown clinical trials.

Regards, Mark
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Postby Arron » Thu Jul 29, 2004 3:31 pm

posted on the front page... thanks Nemotoday for pointing this one out to us!
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AIMSPRO

Postby fryerbj » Sat Mar 19, 2005 9:04 am



Hi All
It seems such a long time since anything new was added to this thread.

The trial at St Georges was cancelled but no one seems quite sure of why.
So much speculation but no real facts.

I guess we cannot be told at this time due to legal reasons but I am sure it will be published sometime in the future.

There was a report from Daval saying the Oxford trial was sucessfull but did not say what the trial was for ?.

Has anybody out there got any late news to share

Regard to you all Brian
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Postby DRWHO » Mon Mar 21, 2005 8:42 pm

Great postings on Aimspro. I am interested in the final cost of the drug as the ABCs Rebif and Novantrone are outpriced and as far as I can see they don't deliver much to the majority of patients that use them...by their own data, 34 to 36 percent of the individuals that use the drugs, stay the same or get better, leaving aproximately 65 percent getting worse or perhaps worse at a slower rate. The Aimspro study with only 40 patients might not seem significant but one must consider that initial studies for approval of Copaxon only had a total of 50 patients. Later and larger studies brought the results into the same range as the other available drugs, Avonex and Betaseron. My concern about the cost of any drug that has to compete with the existing drugs is that it to will be subject to the Orphan Drug laws if it is to me marketed in the USA. What this means is that to be brought to market it will have to be proven to be significantly better than the existing drugs that are protected under the law. To produce the data to show that it is significantly better it will be subjected to the same rigourous testing that the ABCR&N have undergone. That testing, the drug companies claim, costs 100's of millions of dollars. I am interested in how Aimspro could get around this and still bring an affordable drug to market. My wife who has MS desperately needs something better than what is commonly availabe and I am hopeful that Aimspo would be that something. In my opinion the double blind study has to go and they simply need to monitor change in condition of a large body of patients while considering that the placebo effect is going to account for 25 to 30 percent of the statistic.
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Postby fryerbj » Tue Mar 22, 2005 1:22 am



HI All
There was so much news yesterday from the media on AIMSPRO.
The results of the Oxford trial was published in the Mail also there was a long bit on ITV news.

The full report is published on the web site of Daval.

It was great of Daval to give us all a bit of good news . Brian
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