http://www.davalinternational.com/news/ ... php?nid=23
22/05/07 - The MS Society
We are aware that it is a common practice for those who are interested in learning more about Aimspro to make enquiries of the MS Society. Whilst we approve of the desire to understand our product, we do not consider that the MS Society will be able to provide the level of assistance that is required.
The very nature of our product means that we have to work with the utmost secrecy. Accordingly, details of our activities are only provided to those individuals and organisations that enter into a non-disclosure agreement. The MS Society has not entered into such an agreement and therefore has minimal knowledge of the activities of the company, the trials that are being planned and the feedback from those taking Aimspro.
If you would like to know more about Aimspro or Daval please contact us and, subject to being satisfied as to he reason for your enquiry, and you entering into a on-disclosure agreement we will endeavour to answer all of your enquiries.
http://www.davalinternational.com/news/ ... php?nid=24
22/05/07 - Clinical Trials
The UK based manufacturer of Aimspro has now been awarded an Investigational Medicinal Product (IMP) Manufacturing Authorisation. This will enable activation of Competent Authority and Ethics Committee applications for a UK based multiple sclerosis trial. UK applications for a trial in two rare conditions, namely, one of the leukodystrophies and a rare rheumatological disorder, will then be lodged.
Further trials in two non-UK European countries, North America and Australasia are in the planning phases. Once arrangements have been completed, these trial protocols will also be submitted to the relevant authorities for approval.
This is from today's Guardian newspaper in the UK
On sale in the UK: unproven goats' blood treatment for MS patients
• Remedy 'promoted like a religion' by charity
• Patients paying £19,000 a year for unproven product
Sarah Boseley, health editor
Monday June 11, 2007
Multiple sclerosis sufferers are spending their life savings and running up large debts to pay for a treatment derived from goats' blood that is being sold in Britain without any scientific proof that it works.
The MS Society is concerned about promotion and sales of the treatment, called Aimspro, to people with the progressive disease who have few other options. It has called on the firm selling it, Daval International, to put the drug through trials.
There are also concerns about a registered charity called Proventus, which was set up to lobby for greater access to Aimspro, but now says that it has broadened its field to a range of largely alternative products for MS.
Proventus, many of whose trustees and officers have small shareholdings in Daval, organises road shows to talk about Aimspro to people with MS. A recent event in Wimborne, Dorset, was described by one man who attended as reminiscent of a religious rally. "It was a very evangelical meeting. Others who were there said it was like a Billy Graham sermon," said Tim Worner, who runs a support group in Bournemouth for people with MS and invited Proventus to speak to it.
"A guy at the back of the hall stood up and said he took Aimspro once a week and was better. He said he had been in a wheelchair and used two sticks. He walked to the front and gave us a short talk on how he spent £180 to inject it once a week and how he wished he could afford to spend twice that. That's a good-sized mortgage payment."
Aimspro is made of the blood of goats that have been injected with killed HIV virus. The theory is that the antibodies produced stimulate the body's immune system against MS and other neurological and inflammatory diseases.
In the seven years since Daval was set up only two very small trials of Aimspro have been done. One was inconclusive and the other was stopped early.
Daval insists it will soon launch another small-scale trial, but in the meantime supplies of the drug - which has to be kept in a freezer until just before it is injected under the skin - are being shipped around the country to patients who pay £180 a vial. Two injections a week are recommended, which means some patients are paying out almost £19,000 a year.
Proventus estimates that around 300 people are taking Aimspro, although as many as 500 may have tried it. "The society has always said that Daval International, like any other organisation that wishes to bring a therapeutic product to market, has to go through the current processes like anybody else," said Lee Dunster of the MS Society.
"There is a structure in place to protect people. There has been almost a flat refusal to go down that route.
To make this available off-licence to people who are vulnerable borders on exploitation."
The MS Society accuses Daval of exploiting a loophole in the law to sell the drug. Aimspro has a "specials" licence, which means it can be supplied to an individual named patient if the patient's doctor agrees to write a prescription. It received the licence because it has an "orphan drug" status in Australia - granted after it was tried in four children with a rare and fatal disease called Krabbe's, for which there is no treatment. But a "specials" licence exists so that a drug can be manufactured to the specific needs of a single patient at the behest of a doctor - and is not intended for general marketing.
The Medicines and Healthcare Products Regulatory Authority, which grants licences and oversees drug safety, said that the company was under investigation, but could not comment further.
Bryan Youl, Daval's clinical director, told the Guardian that he had applied to the MHRA for a trial in January to study the effects of Aimspro in alleviating bladder symptoms of MS. "It has taken a long time. The documentation is pretty complex." He was waiting for a response from the MHRA, and planned further studies. "It has not been through lack of intention that we haven't trialled this."
Dr Youl added Aimspro was not an MS cure, but a palliative medicine, intended to treat symptoms. He said it was not unusual for medicines to be made available to patients "off-label" - outside the terms of the licence. "It is up to the doctor prescribing it to decide whether the patient truly requires the medication," he said.
The Charity Commission is looking into Proventus. Concerns have been raised with the commission over its administration and management, and possible conflicts of interest. In a statement the commission said: "We are currently considering these concerns to determine what action, if any, it might be appropriate for us to take." It is understood to have particular concern about the role of Proventus in public appeals for funds by MS patients who desperately want to buy Aimspro.
A Dorset newspaper ran a story about a woman who was dependent on benefits and had spent all her savings on the drug. At the foot of the article a request was made for cheques to be sent to Proventus.
Dr Dunster also went to a Proventus rally. "It clearly was a sales pitch - no bones about it at all."
"They had someone in the audience who talked about how much of a difference goat's serum makes to them. The guy walked to the front and said that was not possible a few years ago. I am really sad and disappointed that this kind of activity goes on. When you are sitting in an audience of 50-60 people, the majority of whom have a progressive condition, with inexorable decline in mobility ... it gives a very hopeful message for individuals who have very little else at the moment."
John Slack, Proventus's chairman of the trustees, was diagnosed with MS 15 years ago and says he believes Aimspro helped him. "We are a group of volunteers who are desperately trying to find a treatment for MS sufferers. There is virtually nothing out there - that is the sad thing. There are 100,000 people with MS in this country. We feel as if we are totally forgotten. If we are promoting Aimspro, we're simply saying there is a future out there because there is something on the horizon." He had a few shares in Daval - but had bought them out of gratitude when he was supplied with Aimspro for nothing as one of the earliest patients by the managing director, David Shotton. He now has to pay.
A guy at the back of the hall stood up and said he took Aimspro once a week and was better. He said he had been in a wheelchair and used two sticks. He walked to the front and gave us a short talk on how he spent £180 to inject it once a week and how he wished he could afford to spend twice that. That's a good-sized mortgage payment."
SPMS, 54 yrs old
Taking it day by day
http://www.mssociety.org.uk/news_events ... rdian.html
Unproven goat serum treatment under the microscope
11 Jun 2007
The Guardian today looks into concerns raised by the MS Society about the promotion and sale of Aimpsro - a treatment derived from goat serum that is currently available on a specials licence to people with MS who are prepared to pay for it.
Today's Guardian story, 'On sale in the UK: unproven goats' blood treatment for MS patients' focuses on the ways in which the drug has continued to be promoted and sold to people affected by MS, despite a lack of any trial data supporting its safety and efficacy.
MS Society chief executive Simon Gillespie said: "The MS Society has been calling on Daval International, who make Aimspro, to put it through proper trials for more than two years. During that period, hundreds of people with MS have been paying to use the treatment.
"The safety of this product for human use has not been proven, and there is a distinct lack of evidence for its effectiveness. Without rigorous proof of safety in clinical trials, no drug can be approved for sale by the regulators. The need to prove safety and efficay in clinical trials before bringing a drug to market has been circumvented and Aimspro is being sold direct to hundreds of people with MS as a safe and effective drug.
"We are particularly concerned that people with severe MS - who have few or no alternative options - are being urged to run up debt to pay for something that has not been proven to work. This is simply not acceptable."
A charity, Proventus, has been holding 'roadshows' throughout this time advocating the use of the drug. MS Society members have attended a number of these and raised concerns with the Society about the tone and content, which were borne out when our research team attended sessions to see for themselves.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has been aware of the MS Society's concerns for two years and has confirmed that Daval are under investigation, but has so far not taken any action.
Simon added: "We would like to see the regulator take some action."
12/06/07 - MORE SLOPPY MEDIA REPORTING ON AIMSPRO
The Monday 11th June edition of The Guardian carries a piece on Aimspro written by Sarah Boseley which is largely inaccurate and in part is based on mischievous and near slanderous comment the paper apparently received from the Multiple Sclerosis Society.
The MS Society is reported as saying that it accuses Daval of exploiting a loophole in the law to sell Aimspro and despite their calling upon Daval to conduct clinical trials, there has been almost a flat refusal to do so. This is so far from the truth that one wonders whether the MS Soc has an ulterior motive for continually sniping at Daval and Aimspro. They have previously acknowledged that they receive funding from major pharmaceuticals.
Remarkably, within hours of publication, the MS Soc web-site draws prominent attention to this article and it's Chief Executive states that the need to prove safety and efficacy in clinical trials has been circumvented!
Rather than addressing all the inaccuracies in the article we would just like to make the following points:
1. The biochemical and immunological effects of Aimspro have been demonstrated scientifically in a range of both in vitro and in vivo investigations. These studies indicate that Aimspro can modulate the immune response and provide a mechanism by which this occurs.
2. A complete characterisation of the product has been communicated to the Medicines and Healthcare Products Regulatory Agency as required by Clinical Trial applications, the first of which is currently being considered.
3. Daval does not hold a specials licence. The manufacturer has such a licence granted to it by the MHRA for the specific purpose of preparing Aimspro. Further, the manufacturer has in the past few weeks been granted a licence to prepare Aimspro as an Investigational Medicinal Product for clinical trials.
4. Aimspro is not made available "off licence" as that could only apply to a product which has a marketing licence.
5. Safety is a prime concern of Daval. To date over 19,000 individual doses have been administered by doctors and under the "yellow card " system no ill effects have been reported by these doctors to the MHRA as would be required by law.
Can goats' blood help beat MS? My mother is walking proof it can
By VICTORIA LAMBERT - More by this author »
Last updated at 11:08am on 19th June 2007
<http://www.dailymail.co.uk/pages/live/a ... rtComments>
Trial: Jackie Llewellyn-Bowen with her husband Laurence
When her mother, Diana, began taking an unlicensed experimental drug made from
goats' blood for multiple sclerosis, you might imagine Jackie Llewellyn-Bowen
would have had a few nagging doubts.
But if she did, these were quickly allayed. 'Three weeks after she started
taking it, I went to my parents' home. My mother was standing in the hallway,'
says Jackie, wife of Laurence Llewellyn- Bowen.
'She beamed at me and said: "Look - no stick!" She wasn't using a frame,
hobbling or grabbing at furniture to find her balance. She had gone back to the
mobility she had the year before.'
All over the country, sufferers of MS and their families were hearing of Aimspro
and clamouring for it. Some were able to get hold of it, although no one has
ever established how many.
Yet, just three years later, its true value is being challenged by medical
experts and charities, many of whom are unable to speak publicly because they
are involved in complicated litigation with Daval International, the
pharmaceutical company behind the drug.
Most significantly, the MS Society has just revealed it is concerned that users
of Aimspro, a potential anti-inflammatory treatment, are spending their life
savings and placing too much faith in a drug that is untried and not properly
tested. As the drug has not been formally evaluated, it is impossible to judge
whether it works.
Moreover, the Society is raising concerns that the drug is being promoted in an
evangelical fashion by the charity Proventus (set up to lobby for wider access
to drugs such as Aimspro).
MS is a debilitating and incurable neurological condition - the result of damage
to the nervous system. Vital messages are not transmitted properly from the
brain to the body. There are 85,000 people diagnosed with it, with varying
degrees of severity.
There are four types of MS. Benign MS accounts for 20 per cent of cases and
causes a few mild attacks but no longterm symptoms. Relapsing remitting MS
causes sporadic attacks from which there are periods of total remission.
Secondary progressive MS often starts with these clear-cut attacks and
remissions, but over ten to 15 years becomes more disabling.
Finally, primary/progressive MS affects 12 per cent of sufferers and has a slow
onset, beginning with walking difficulties but progressing steadily.
Authorised treatments include betainterferon and Copaxone, disease-modifying
drugs, which some patients find reduces the likelihood of relapse by one-third.
A cannabis spray called Sativex recently became available to be prescribed on a
'named patient' basis: it is not licensed for general use but can be made
available for a specific patient or need.
Some sufferers find it alleviates the worst symptoms. But most find day-to-day
management of their condition a challenge. And for those with
primary/progressive MS, no drugs are available to help.
Aimspro is derived from purified serum extracted from the blood of goats, which
have been injected with dead, harmless HIV-infected cells created in the lab
rather than taken from humans. It is thought this creates antibodies, which
appear in the serum and can help reduce the inflammation likely to be at the
root of many major illnesses including MS.
The stories about its efficacy that first emerged seemed miraculous: men and
women were apparently throwing down their walking sticks and turning over their
Alan Osmond of Seventies pop fame tried it and abandoned his leg brace, saying:
'Almost immediately I could walk faster, better, quicker.'
A trial got under way at St George's, Tooting, a leading London hospital. GPs
sought ways to get their patients a free course from Daval. And patients
clamoured for a chance to try it, even if they had to pay for the £180-a-time,
twice-weekly injection privately.
Those who did get the drug couldn't wait to tell their stories: they were
feeling less pain, their eyesight improved, they had more energy, some found
physical sensations were renewed, others just felt better in themselves. Perhaps
this drug really was the breakthrough all had hoped for.
The Llewellyn-Bowens thought so. Diana had fallen ill three years previously,
aged 65. After suffering a slipped disc in her back, she had felt increasing
pain in her left leg which was causing her to limp.
She was diagnosed with primary/ progressive MS, which meant her condition was
likely to decline rapidly. Jackie discovered the trial at St George's and tried
to get her mother on it.
When told it was full, she found Dr David Maziels, a Kent GP, who agreed to
prescribe it as part of another trial group.
There was just one thing missing - the link that meant Aimspro could be assessed
by the National Institute for Clinical Excellence and become available to all: a
clinical peer-reviewed trial. Instead, the trial under way at St George's was
suddenly brought to a halt by Daval and without explanation.
A hospital spokesman said: 'A trial to establish the safety of a drug consisting
of HIV-inoculated goat serum on patients with secondary progressive MS was
stopped by Daval in March 2005, without consultation or investigation, after
nurses found a small number of treatments were defrosting too rapidly to be
given to patients.
'The trial was not endangered in any way, as back-up supplies of the drug were
given to the patients.
'The trial had been conducted according to an agreed clinical protocol and
without problems for nearly a year.
'We were surprised by the abrupt decision to withhold supplies of the drug based
on this one instance after so many months of work without discussing it with us
Daval has continued to supply the drug privately. Doctors are still able to
prescribe Aimspro because it is produced under a specials licence under the
Medicines and Healthcare products Regulatory Agency (MHRA).
It does not approve the medicine itself, but gives a licence to a pharmaceutical
site, its staff and approves its basic ingredients.
The responsibility for ordering the drug is then down to a GP who is comfortable
to prescribe it.
The MHRA is clearly not happy with the current situation. It has an ongoing
investigation into Daval for offences under the Medicines Act 1968, including
illegal sale, supply, manufacture and advertising of an unlicensed medicine.
The lack of a clinical trial is a concern for the MS Society. Dr Lee Dunster,
head of research for the Society, says: 'There have been no safety and efficacy
trials which runs against standard practice for a company that wants to bring a
therapeutic agent to market.
'We have been told that the company intends to get trials under way but there is
a huge difference between intention and action.'
Dr Dunster is not attempting to prejudge the results of any trial - he is aware
that many MS sufferers are happy with the drug.
He said: 'If it is safe and proven, that is great for everyone. Until then we
cannot support it. We know there have been some adverse reactions to the drug.
What we don't know is what this might do to the body over time.'
However, Brian Quick, managing director of Daval International, denies the
suggestion the company is dragging its heels over testing or trying to abuse a
'All I want to do is the get the trials under way and done,' he says.
'The MS Society know that we are trying to do this; and that we concluded a
small one in Oxford which found the product safe. We stopped the trial at St
George's, as we felt the product was not being handled carefully enough, which
would have affected both its efficacy and the trial results.
'It's not in our interests not to do trials; we want to get this drug on to the
'The application is with the MHRA, we hope to have a positive response within
three to four weeks, and we are lined up now to begin clinical trials in
September or October this year.'
The MHRA investigation, he says, is 'a minor matter'.
'We would like the MHRA to pursue their investigations and get this over with.
We are not selling the product illegally.'
It's been two years since Diana took Aimspro - the family took a joint decision
that it was too difficult to get hold of and too expensive for the results it gave.
Jackie is sure her mother got some benefit, but says it's impossible to know
what would have happened if they hadn't gone down that route. But she is glad
'Aimspro has no serious side effects, no toxicity, so why shouldn't people give
it a go? 'My mother is still getting around now. But you can't say if it is a
longterm effect of the Aimspro.'
Where she and Dr Dunster agree is on the need to examine the serum more closely.
She says: 'From what I have seen, this drug offers hope. Why not investigate it
further and then judge it?'
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