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    You are here : Home » MS Research News » Drugs » Aimspro (Goats Serum) » Aimspro Latest News

    Aimspro Latest News

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    Daval International Limited Gains Approval for Phase IIB Trial of Aimspro(R)
    Daval International Limited, a UK private company, announces MHRA and IRB (Ethics Committee) approval of a London based Phase IIB trial of Aimspro(R), its hyperimmune caprine serum derivative.

    This double-blind placebo-controlled cross-over study will seek to detect a beneficial effect on bladder function in patients with Secondary Progressive Multiple Sclerosis, following open-label observations over several years in a number of informed consent, "compassionate basis" patients.

    Aimspro has an "export only" listing on the Australian Registry of Therapeutic Goods and a TGA Orphan Status Designation for the treatment of Krabbe's disease. An IND application is being lodged for a further MS trial in the United States.

    Aimspro is a frozen medication, given as a 1ml sub-cutaneous injection every 4 days. It is believed to have a pronounced and sustained anti-inflammatory action with an associated, novel effect of lowering sodium channel triggering voltages in nerve fibres. MHRA applications for two further clinical trials are to be lodged within the next 3months.

    Daval International Ltd. has recently been accepted as a member of the Association of the British Pharmaceutical Industry. "APBI"
    Daval International Limited.

    Daval International Limited is a privately owned British pharmaceutical company, which, since 2001, has been developing an immunologically active human and veterinary medication derived from goat serum. Some 20.000 doses of Aimspro have been administered, mainly to human subjects with multiple sclerosis, with an excellent safety and tolerance profile.

    Source: Daval International Ltd (27/11/07)

    Can goats' blood help beat MS? My mother is walking proof it can
    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 100,000 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 wheelchairs.

    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 first.'

    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 specials licence.

    '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 market.

    '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 they did.

    '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?'

    Source: The Daily Mail ©2007 Associated Newspapers Ltd (19/06/07)

    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

    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.

    Source: Guardian Unlimited © Guardian News and Media Limited 2007 (11/06/07)

    Serum will give me back my life
    A multiple sclerosis patient is appealing for help to buy a medication based on goat serum that she says is giving her back her life.

    Former probation service secretary Angela Garrett, 49, of New Milton, was diagnosed with MS in 1985. The condition affects the protective sheath around the nerve fibres of the central nervous system, interfering with messages between the brain and other parts of the body. The disease remained fairly stable until Angela's husband died of heart failure at the age of 52, then began to progress rapidly until she ended up having to use a wheelchair to get around the house.

    "I would walk into the kitchen a couple of times a day. That was all I had the strength for. I spent the rest of the day lying on the bed looking at the television or phoning people for a chat. That's all there was in my life," she said.

    Three years ago, she heard about a new MS treatment called Aimspro. She has now been having the injections for the last seven months, funding the £182 a week cost from her savings, which have now run out.

    Aimspro is not licensed in the UK, and can only be prescribed to named individual patients, with supply arranged by a doctor and the Sussex-based manufacturer Daval International.

    The MS Society says: "Despite anecdotal evidence that suggests Aimspro is beneficial for some people, there have not yet been sufficient clinical trials to assess its safety and efficacy."

    But Angie says she noticed an improvement in her mobility within three weeks of starting the treatment. With the help of a private physiotherapist, she is continuing to improve.

    She now dreams of walking in the countryside again, or even around the shops. "I'm having remission for the first time since December 2004," she said.

    "I can hardly believe the difference the medication has made and live in hope that it continues this way. Even if I don't walk again, I'm much more mobile than I was. At one stage, I couldn't even turn on my electric toothbrush because I was so weak. I had to get people to cut up my dinner for me - you feel like a silly little child."

    Source: Daily Echo Online © Copyright 2001-2007 Newsquest Media Group (29/04/07)

    Trial protocol submitted for Aimspro - Bladder symptoms in secondary progressive multiple sclerosis.
    Daval International Limited anounced it now has links with a number of key clinical and scientific researchers worldwide, with a growing level of interest being shown in the setting up of randomised double-blind, placebo controlled clinical trials of AIMSPRO.

    A European leader in the study and treatment of multiple sclerosis has recently submitted a trial protocol for consideration by an Institutional Ethics Committee and the Competent Authority.

    This long term study will focus on bladder symptoms in secondary progressive multiple sclerosis.

    Source; Daval International (24/04/07)

    Daval Aimspro (Sunday Times) Statement 30/11/06
    30/11/06 - Managing Director's statement regarding The Sunday Times

    In response to the misreporting in The Sunday Times, dated November 26 2006, regarding Aimspro and Daval International Ltd., I wish to disseminate more widely the information made available to shareholders at last Tuesday's Annual General Meeting.

    The MS sufferer in Lincolnshire had, at her husband's request, one free treatment of Aimspro in 2004 and her own medical team has confirmed that there was no change in her condition following this treatment. Therefore no adverse report by her clinicians was necessary and there is no MHRA investigation into the matter. The article is a malicious fabrication and a complaint has been lodged with the Press Complaints Commission.

    With regard to the sensational headline regarding a criminal probe into the "MS wonder drug" it is untrue that the MHRA are looking into the way that Aimspro is being sold and marketed. It is true that following a complaint made to the MHRA by a known source earlier this year, we cooperated with the regulators in an investigation which they were duty bound to make. Because we have not received any subsequent notification from the MHRA this incident may be loosely described as "ongoing" but it has nothing to do with Aimspro being prescribed by doctors as a "special" nor its safety.

    It is in everybody's interest, and particularly Daval's, for Aimspro to be the subject of further independently conducted trials. Protocols for new trials to be held in the UK and Australia have been developed and it is hoped that they will be underway in the first quarter of 2007.

    (01/12/06)

    Criminal probe into MS ‘wonder drug’
    A DRUG company is under criminal investigation for the way it has marketed an unproven “wonder” treatment for multiple sclerosis to thousands of patients.

    The firm, Daval International, chaired by a discharged bankrupt described by a High Court judge in 2002 as a liar, has been promoting its drug as a “major scientific breakthrough”.

    It is being distributed across Britain using a licence granted by a government agency last year despite serious concerns from doctors and multiple sclerosis (MS) experts.

    A Sunday Times investigation has found claims that the company misrepresented research to present the drug, Aimspro, in a more positive light.

    The Department of Trade and Industry has expressed concern that the company is trading “on future hope” — taking money from vulnerable investors in the expectation that it will become a clinically proven drug.

    So far the drug, which is based on a serum from goats injected with inactive HIV virus, has never been properly tested in full clinical trials to assess its safety and efficacy.

    However, the Medicines and Healthcare Products Regulatory Agency (MHRA) and government ministers have allowed it to be sold under a “specials” licence which is not designed for the marketing of drugs.

    The MHRA was the body that authorised the so-called “elephant man” drugs trial at Northwick Park hospital, which left six healthy young men critically ill.

    A key figure lobbying for the drug has been Lord Elder, a friend of Gordon Brown since their school days and former adviser to Tony Blair. The peer, who has £300,000 worth of shares in the company and acts as its paid adviser, attended meetings between Daval executives, Brown and other ministers.

    This weekend, following The Sunday Times inquiries, the MHRA disclosed that it had been investigating the drug for some time. It is now understood to be looking into the way Aimspro has been sold and marketed to patients in possible breach of the Medicines Act.

    The statement said: “The MHRA is conducting a criminal investigation into an unlicensed medicinal product known as Aimspro which is promoted by Daval International Limited.”

    Daval has built significant demand for Aimspro among Britain’s 100,000 MS patients. Last month, a petition with more than 20,000 signatures was presented to Downing Street calling for NHS backing for the drug.

    Daval and its supporters claim that Aimspro “dramatically” alleviates the symptoms of MS, a chronic disease that attacks the central nervous system. Over the past two years a number of stories have appeared in the media claiming patients have regained eyesight and thrown away their walking sticks after taking the drug. During this time, Daval has raised almost £4m from investors on the promise that Aimspro will one day become a clinically proven drug.

    David Shotton, Daval’s chairman and main shareholder, was discharged from bankruptcy shortly before he set up the company. The company’s finance director, Graham Ralph, is also a discharged bankrupt.

    Shotton, 65, has twice been castigated by High Court judges. In a 1995 case over a disputed bank loan the judge said he was a “wholly unreliable witness” who had a “willingness to advance claims he knew were unjustified”.

    Seven years later another judge found that he had lied to attract funding for business schemes. The judge described Shotton as a “most unsatisfactory and untruthful witness . . . well practised in the use of lies and half truths”.

    Asked to comment on his suitability as chairman of a drugs company, Mr Shotton said last week he had been truthful and “it was unfortunate that the judges preferred the evidence of others”.

    In six years the company has commissioned only two proper clinical trials of Aimspro. The first, at St George’s hospital, south London, was aborted half way through after a dispute between the hospital and Daval. The other, at the Radcliffe hospital, Oxford, was too small to establish the drug’s safety.

    At the time, Daval was claiming that even severe damage to the optic nerve could be repaired by treatment with Aimspro. But the Oxford trial found no evidence to substantiate this.

    Nonetheless, a year later Daval wrote to the government claiming that “clinical, scientific and empirical evidence clearly establishes our clients have a product which will bring substantial relief to thousands of sufferers”. It emphasised that the Oxford trial had been “significant” and “successful”.

    A key researcher from the Oxford study said last week the results had been “wholly misrepresented” by Daval. Dr Nikos Evangelou, a consultant neurologist at Queen’s medical centre, Nottingham, is also critical of the lack of research: “It’s inappropriate to promote miraculous patient stories without trial results.” Daval said last week it had never claimed that Aimspro could restore damaged eyesight.

    The product has been made available to hundreds of patients through GPs who have been prescribing it on an “informed consent” basis. Daval claims that none of these patients has ever reported an adverse reaction.

    But The Sunday Times has spoken to the husband of an MS patient in Lincolnshire who sent a 30,000-word complaint to the MHRA about the drug. The husband, who does not wish to be named, claims Daval offered his wife free treatment with Aimspro after he agreed to buy £5,000 worth of its shares.

    He claims his wife’s condition deteriorated rapidly after she had been given the drug by Dr Ian Brooman, a GP who was also a director of the company. “Within hours there was a reaction and she started going downhill,” he recalls. “It was as if she had been poisoned.”

    His wife’s sight grew worse, she had spasms on her left side and suffered severe pain, according to his statement. But Daval refused to believe that the drug was responsible. Later Dr Brooman returned to take a blood test and retrieved the couple’s supplies of Aimspro.

    The husband has passed his documents and tapes to the MHRA. However, last week Dr Brooman, who still administers Aimspro and has shares in Daval, said he was “not aware” of any “reported adverse reaction” from his patients.

    The complaint was made in late 2004 and the MHRA is still investigating. Last week Daval said: “Clinicians are currently treating over 200 patients with Aimspro and there have been no reports of adverse reactions.”

    The drug has been the subject of an extensive lobbying campaign. In March 2003, Lord Elder attended a meeting at the Treasury in which Shotton and his team met the chancellor for talks. In the meetings, Daval directors described the product and its “remarkable performance”. The purpose of the talks was to obtain government funding for further research and to “fast-track” the drug to approval by the regulator.

    Discussions were arranged in 2004 with Lord Warner, the health minister who was then responsible for the MHRA, and Liam Donaldson, the government’s chief medical adviser.

    Last November Daval had a breakthrough when the firm it uses to manufacture the drug was given a “specials” licence by the MHRA. “Specials” are intended to certify that a manufacturer can safely make a drug on the request of a doctor as a one-off for a specific patient.

    Documents seen by The Sunday Times indicate that Daval was encouraged by health ministers and the MHRA to go down this route. The “specials” licence is now being used by Daval to make widespread sales of the drug, by-passing the higher regulatory standards of a full marketing licence. It promotes the product on its website at £3,000 for a two-month course.

    A source at the MHRA last week described this as “licensing through the back door”. This raises questions about why the company was apparently encouraged to use the “specials” system.

    The decision is all the more remarkable as the DTI’s companies investigation branch has been looking into Daval and its chairman for over two years.

    The Sunday Times has seen a letter sent to Daval by a Treasury solicitor on behalf of the department in March 2005 which expresses concern about Daval’s relations with investors with MS who, it says, “may be led to understand that making an investment in Daval shares would give them accelerated and/or privileged access to (Aimspro)”. Daval claims this allegation was unfounded.

    Daval, which holds its AGM on Tuesday, said last week it had no knowledge of the MHRA investigation. It added: “Over the last 18 months work has gone into improving Aimspro and ensuring it complies with good manufacturing process. Full clinical trials are imminent.”

    Yesterday the MS Society came out publicly against the drug: “We advise people against seeking the treatment until (clinical trial) evidence is published and have become increasingly concerned that the drug continues to be promoted and used without it.”

    Professor Gavin Giovannoni, an MS specialist at Barts and the London hospitals, said: “This is a very vulnerable group of desperate patients who have a chronic illness. They’re prepared to try anything, and that’s the tragedy of the situation.”

    Source: The Sunday Times Copywrite Times Newspapers 2006 (26/11/06)

    Cash appeal for MS 'miracle drug'
    A Kent woman with multiple sclerosis is trying to persuade the government to fund a new treatment for MS patients.

    Hilary Price, from Knockholt, was in a group who took a petition to Downing Street calling for the drug Aimspro to be made available on the NHS.

    It is derived from goat's blood and has been developed by Daval International, in Eastbourne, East Sussex.

    Mrs Price, 57, who is permanently in a wheelchair, said the "miracle drug" had enabled her to have a normal life.

    The mother-of-two was diagnosed with secondary progressive MS 14 years ago and needs a mechanical hoist just to get out of bed.

    However, after regular doses of the drug Aimspro, which cost £180 each, she said much of her mobility returns and the pain goes away.

    But the effects wear off and the doses need to be repeated.

    Multiple sclerosis is a disease of the central nervous system and affects one in 700 people.

    Its symptoms include pain, immense fatigue, and problems with sight, mobility and co-ordination.

    'Minimal side effects'

    On Saturday, Mrs Price and her husband joined other MS patients and carers to hand over more than 20,000 signatures on behalf of the MS charity, Proventus.

    Testing is in its third and final stage and members of Proventus want the government to speed up adoption.

    They claim that out of 15,000 doses administered so far, no one has suffered any significant side effects.

    The Multiple Sclerosis Society, however, said it wanted MS patients to have proper assurances about the effects of the drug.

    Spokesman Matthew Smith said: "There have not yet been sufficient clinical trials to assess its safety and its efficacy."

    Source: BBC News Copywrite BBC 2006 (01/11/06)

    WHY SHOULD WE FORK OUT £19K A YEAR FOR DRUG TO MAKE ALL OUR LIVES MORE BEARABLE?
    Tiger Tim in plea over life-changing MS jab.

    Radio DJ Tiger Tim has told of his battle to have a miracle drug made available on prescription - after revealing he spends thousands of pounds a year on life-improving jabs.

    The multiple sclerosis patient - real name Tim Stevens - was astounded by the effect that Aimspro had on his illness.

    But the American-made drug has still to get a full licence in Britain - and buying it privately for the recommended two injections a week costs a staggering £19,000 a year.

    Each jab costs £180 and Tim can only afford one injection a week.

    Now he plans to enlist the help of the Queen when he gets an MBE next month.

    Tim said: "The minute I have the injection, I feel alive again. I just find it ridiculous that there are all these people wanting to be on it and they can't afford it."

    Drug company Daval International say Aimspro - which is made from goat blood - can help repair damage to nerve coatings that causes the symptoms of MS.

    For Tim the effects have been clear. He said: "Before the treatment I couldn't use my left hand at all and as I'm left-handed it was a bit of a problem.

    "Just after my first injection, I was in the shower and I started getting the feeling and power back and I was even able to wash my hair."

    Tim's bladder control also improved as well as his speech and energy levels.

    He said: "My skin got better, my legs got stronger and my waterworks were better too. I was getting very incontinent but now they are back in order again.

    "My vision and speech improved dramatically and I had a zest for life again.

    "I'd stopped doing all the work for charity and had just been concentrating on my job at Radio Clyde.

    "Without the treatment, I was going downhill and would probably have had to quit the radio two years ago but all of sudden I was able to get out and about.

    "Now I'm doing Radio Lollipop for sick kids at Yorkhill Hospital in Glasgow and charity balls at night for MS. I'm now able to do things for charity every weekend.

    "It's been a lifeline for me professionally and personally. You can't make yourself understood if you are slabbering but now all that has cleared up."

    But it is the plight of fellow MS patients who can't afford the drug which makes Tim angry.

    He said: "At £180 a jag, it's a heck of a lot of money, it's stupid and it's hard going. It's a lot but then what price is life?

    "You are meant to have two a week but I have only one a week because it's so dear. I have to fork out £3000 a time which is hard because, at the back of your mind, there's always the question of how long I can keep working. When I pick up my MBE, I'm hoping to speak to the Queen about it - if I get the chance.

    "Ninety-nine per cent of people I speak to can't afford it. I get emails and phone calls about people contacting bank managers trying to get hold of the money.

    "I've been doing charity work to raise funds for others to get it and I raised over £32,000 last week.

    "It makes me feel bad when people ask, 'How do I get it?' and they're looking at you with begging eyes.

    "It's terrible because there are people a lot worse off than me and my heart goes out to them. It needs to pass through government. It seems to take years before things get looked at."

    Tim, 57, first started taking the drug on an informed consent trial basis late in 2003.

    He said: "Over the last 13 years, I've tried everything. It wasn't so bad for the first six years but gradually my health worsened, year upon year.

    "When you're in that situation you'll try anything and I tried Chinese medicine and reflexology amongst other things.

    "When Aimspro came along I thought, 'Let's try it'. I was not expecting anything incredible.

    "But all the patients I knew on the informed consent trials improved in some way or another. None of them have since gone back to the way they were before.

    "Aimspro repairs the myelin sheaths in the spine - the protective coating which becomes scarred with MS."

    A spokesman for the MS Society said: "We are aware of significant anecdotal evidence that people who have used Aimspro have reported benefits from it.

    "But from the society's perspective, we want to see the results of properly controlled trials into its effectiveness and safety as we would with any potential treatment for a very variable and fluctuating condition like MS."

    Source: The Daily Record (02/10/06)

    Smiling through the pain at emotional meeting
    Thanks to the kindness of one stranger, Steve Kew now has the chance to live longer.

    The Multiple Sclerosis patient had never met Teresa Marsh, but she has become the main reason why his five children could see their dad's life extended.

    Mrs Marsh was so moved after reading of his plight in The News she stumped up the £3,000 he needs for a course of experimental drugs.

    Despite his pain, Mr Kew, of Fratton, Portsmouth, beamed with delight as he met Mrs Marsh for the first time, while his benefactor broke down in tears at finally seeing the man she was helping so much.

    The money she has donated will now pay for a course of Aimspro, a new drug which is derived from goat's blood and offers hope of relief from the symptoms which have left him bedridden.

    Mrs Marsh, 76, of Kirby Road, Copnor, said: 'We did it because we felt he needed it, and because we thought we could make a difference to his life. We just hope some good comes of it.'

    Source: Portsmouth.co.uk All rights reserved © 2006 Johnston Press Digital Publishing.(02/07/06)

    Daval International issued this statement last night, 22/05/06, with regards "Internet Prescriptions"


    Internet prescriptions

    "It seems that a small number of prescriptions for Aimspro , written under the UK "Specials" provisions , may have been issued via the internet without direct patient supervision . We regard this lack of clinical involvement unethical and unacceptable under GMC guidelines , given Aimspro's status as an unlicenced medication about to undergo further clinical trials .

    The maintenance of an excellent safety record is Daval's over-riding priority and so in those cases where we are able to establish that there has been no direct contact between prescriber and patient , Aimspro will not be dispensed ."

    Aimspro now available in UK
    Aimspro is available now , on the Specials Named Patient Basis , which is when a doctor writes a prescription for the UNLICENSED medication and the patient covers the cost.

    All information on this can only be sent to a doctor if they write to Daval International requesting the pack.

    The main points to remember are: 

    • The procedure: Go to your own GP and ask him or her to write to Daval at their Eastbourne address (below) and ask for the doctor's pack.
    • In that pack is a prescription form for Aimspro for 15 phials.
    • -This prescription must be sent to the pharmacy listed in the Pack.
    • The Aimspro can either be collected in person from this pharmacy in London, or sent by post, but as it needs to remain frozen it is unclear how this will be done.
    • At present, each phial costs £182. They expect the price to come down in time.
    • The dose is twice a week.(£364 a week!)
    • It's very easy to inject yourself - tummy or arm is fine. Or someone else can do it for you.

    Daval will also be arranging three further Clinical Trials in the very near future, details of these, if passed by the health authorities, will appear on the Daval International website.

    To contact Daval:

    Daval International Ltd,
    4a Gildredge Road,
    Eastbourne,
    East Sussex,
    BN21 4RL

    Tel: 0800 328 3793
    Fax: 0845 603 1190 
    Email: [email protected]

    (27/04/06)

    Goat serum product “Aimspro” restores conduction in demyelinated human optic nerve fibres

    Abstract

    Acute optic neuritis is a common manifestation of multiple sclerosis. It presents as an episode of monocular blurring of central vision, with a pronounced effect on colour discrimination. While spontaneous resolution usually follows, successive attacks may result in irreversible and often, slowly progressive, visual loss. No medication has yet been available to improve visual function in these chronically affected patients. Here we present evidence of a promising approach to therapy along with electrophysiological indications of a remarkable rapidity of onset.

    For the full paper from the Journal of Clinical Neuroscience click here (23/03/06)

    The first batch of Australian sourced serum has been manufactured and vialled in the United Kingdom
    Following sterility testing Aimspro will be available to those Primary Care Trusts and doctors who have already registered their interest and information packs have been dispatched to them today.

    On receipt of prescriptions, Daval expects to begin delivering Aimspro during the first two weeks of April.

    Source: Daval International Announcement (23/03/06)

    Aimspro on the verge of availability in the UK?
    It is reported that in February or March 2006, Aimspro will finally be imported to the UK from Australia, where it is now being produced.

    Australia, unlike the US, is free of BSE, and patient safety has been of paramount importance to Daval International, the company developing the medication. Immunisation of the goats started in October 2005 and the active serum is now being stockpiled.

    Daval has not been in a position to discuss any aspects of pricing of Aimspro but Proventus say they would expect that the cost of Aimspro will start at not less than £180 per vial. It is hoped that this will come down with increased volume of production.

    All patients who were prescribed Aimspro on an Informed Consent basis, and all those who have already applied, through their doctors, to go on Aimspro on a ‘Specials’ basis will receive a detailed letter of reply from Daval International in February informing them how Aimspro can be obtained.

    It is emphasised that as an unlicensed medical product, availability is subject to prescription, on a limited named patient basis, by a general practitioner or specialist.

    A double blind, controlled trial is planned for MS, to be carried out in the near future. This will look specifically at bladder function and other aspects of quality of life, rather than relapse rate.

    Daval were required to meet very stringent new (2004) UK and EU drug manufacturing regulations, which is why Aimspro was temporarily withdrawn. All aspects of the production of Aimspro now conform to Good Medical Practice – the gold standard of pharmaceutical production.

    Source: Proventus (26/01/06)

    Proventus Aimspro Presentation - 14th December 2005

    Proventus Aimspro Presentation

    The next Proventus Aismpro presentation will be at The Samson Centre, Riverside, Guildford GU1 1LW, on Wednesday 14th December 2005 at 7:00pm.

    Tickets for the presentation are £3 each. Spaces are limited, so if you would like to go please ring 01483 415043. Doors open at 6.30pm, there is disabled access and facilities.

    For directions, please go to the Proventus website

    The Guest Speaker, Chris Moore, is a Consultant Clinical Neurophysicist with extensive knowledge of Aimspro. Current Aimspro patients will also be present to talk about their experiences of using the drug.

    The meeting will be an open forum, with opportunities to ask questions of the expert and current patients.

    Breaking AIMSPRO News - 23rd August 2005
    Breaking News
    The Therapeutic Goods Administration in Australia has awarded Aimspro “Orphan Drug Status” in the treatment of Krabbe’s Leukodystrophy, a serious inherited disease of the nervous system. This condition is characterised by the failure of the myelin sheaths surrounding nerve fibres to develop normally.

    Formal controlled, double blinded trials will now take place in Australia to assess the medication’s efficacy in treating this rare, disabling condition.

    Source: Daval International Press Release (23/08/05)

    Oxford Optic Neuritis Trial Statement by Daval - 18th August 2005

    Daval International have just issued this statement with regards the Oxford Optic Neuritis Trial : Daval Statement

    MHRA Statement on Aimspro 21st April 2005

    The MHRA (Medicines and Healthcare Regulatory Agency) has issued a press statement on Aimspro.

    The relevant talks are being held between Daval International and the MHRA with regard to the "specials" licensing.

    MSRC remain assured by Daval International that they are in "constant and constructive contact with the MHRA".

    Aimspro Update 14th April 2005
    Over the past few weeks the subject of Aimspro has been at the forefront of many people's thoughts.  There is a great deal of speculation and conjecture about what is happening with this therapy, the company involved and the MHRA.

    Proventus, the support group for Aimspro users and those attempting to receive this treatment, have placed a statement on their website www.proventus.org.uk.

    Whilst there is no doubt that the situation with Daval International and the MHRA is complex, MSRC have been assured by the company that the MHRA are working with Daval International to resolve the current difficulties.  The MHRA are intending to meet with Daval International early next week (w/c 18th April) to work out the production side of Aimspro.  The 'issues' have arisen as a result of the change in the GMP (Good Manufacturing Practice) rules from the EU in May 2004.  The position, as understood at the moment, is that the company "falls between two stools" within this set of regulations and therefore the MHRA is having to look at this as a stand-alone case.

    All people receiving Aimspro under the "informed consent" rules are receiving a letter from the company explaining the current situation and what they are doing to resolve it.

    MSRC remain in regular contact with Daval International and Proventus and will continue to provide updates as and when any new information is available.

    Daval Statement - 8th April 2005

    Please click on the link below for a statement from Daval International

    Daval Statement - 8th April 2005

    Aimspro Halt St George's Hospital Trial -29th March 2005

    For the latest Statement from Daval International concerning the halting of the St. George's Hospital Trial Click Here

    © Multiple Sclerosis Resource Centre

    Related Items
    Aimspro - Oxford Optic Neuritis Trial
    Aimspro - Published Research Papers


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